Publications by authors named "Michael Bubenheim"

54 Publications

A regimen with caplacizumab, immunosuppression, and plasma exchange prevents unfavorable outcomes in immune-mediated TTP.

Blood 2021 Feb;137(6):733-742

Centre de Référence des Microangiopathies Thrombotiques, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France.

The anti-von Willebrand factor nanobody caplacizumab was licensed for adults with immune-mediated thrombotic thrombocytopenic purpura (iTTP) based on prospective controlled trials. However, few data are available on postmarketing surveillance. We treated 90 iTTP patients with a compassionate frontline triplet regimen associating therapeutic plasma exchange (TPE), immunosuppression with corticosteroids and rituximab, and caplacizumab. Outcomes were compared with 180 historical patients treated with the standard frontline treatment (TPE and corticosteroids, with rituximab as salvage therapy). The primary outcome was a composite of refractoriness and death within 30 days since diagnosis. Key secondary outcomes were exacerbations, time to platelet count recovery, the number of TPE, and the volume of plasma required to achieve durable remission. The percentage of patients in the triplet regimen with the composite primary outcome was 2.2% vs 12.2% in historical patients (P = .01). One elderly patient in the triplet regimen died of pulmonary embolism. Patients from this cohort experienced less exacerbations (3.4% vs 44%, P < .01); they recovered durable platelet count 1.8 times faster than historical patients (95% confidence interval, 1.41-2.36; P < .01), with fewer TPE sessions and lower plasma volumes (P < .01 both). The number of days in hospital was 41% lower in the triplet regimen than in the historical cohort (13 vs 22 days; P < .01). Caplacizumab-related adverse events occurred in 46 patients (51%), including 13 major or clinically relevant nonmajor hemorrhagic events. Associating caplacizumab to TPE and immunosuppression, by addressing the 3 processes of iTTP pathophysiology, prevents unfavorable outcomes and alleviates the burden of care.
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http://dx.doi.org/10.1182/blood.2020008021DOI Listing
February 2021

Risk of early progression according to circulating ESR1 mutation, CA-15.3 and cfDNA increases under first-line anti-aromatase treatment in metastatic breast cancer.

Breast Cancer Res 2020 05 28;22(1):56. Epub 2020 May 28.

Department of Medical Oncology, Centre Henri Becquerel, Rouen, France.

Background: Endocrine therapy is recommended as a first-line treatment for hormone receptor-positive metastatic breast cancer (HR+MBC) patients. No biomarker has been validated to predict tumor progression in that setting. We aimed to prospectively compare the risk of early progression according to circulating ESR1 mutations, CA-15.3, and circulating cell-free DNA in MBC patients treated with a first-line aromatase inhibitor (AI).

Methods: Patients with MBC treated with a first-line AI were prospectively included. Circulating biomarker assessment was performed every 3 months. The primary objective was to determine the risk of progression or death at the next follow-up visit (after 3 months) in case of circulating ESR1 mutation detection among patients treated with a first-line AI for HR+MBC.

Results: Overall, 103 patients were included, and 70 (68%) had progressive disease (PD). Circulating ESR1 mutations were detected in 22/70 patients with PD and in 0/33 patients without progression (p < 0.001). Among the ESR1-mutated patients, 18/22 had a detectable mutation prior to progression, with a median delay of 110 days from first detection to PD. The detection of circulating ESR1 mutations was associated with a 4.9-fold (95% CI 3.0-8.0) increase in the risk of PD at 3 months. Using a threshold value of 25% or 100%, a CA-15.3 increase was also correlated with progression (p < 0.001 and p = 0.003, respectively). In contrast to ESR1, the CA-15.3 increase occurred concomitantly with PD in most cases, in 27/47 (57%) with a 25% threshold and in 21/25 (84%) with a 100% threshold. Using a threshold value of either 25% or 100%, cfDNA increase was not correlated with progression.

Conclusion: The emergence of circulating ESR1 mutations is associated with a 4.9-fold increase in the risk of early PD during AI treatment in HR+MBC. Our results also highlighted that tracking circulating ESR1 mutations is more relevant than tracking CA-15.3 or cfDNA increase to predict progression in this setting.

Trial Registration: ClinicalTrials.gov, NCT02473120. Registered 16 June 2015-retrospectively registered after one inclusion (first inclusion 1 June 2015).
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http://dx.doi.org/10.1186/s13058-020-01290-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7254698PMC
May 2020

Early Postoperative Renal Dysfunction Predicts Long-Term Renal Function Degradation after Type IV Thoracoabdominal Aortic Aneurysm Surgical Repair.

Ann Vasc Surg 2020 Oct 18;68:316-325. Epub 2020 May 18.

Department of Vascular Surgery, Rouen University Hospital, Rouen, France.

Background: Type IV thoracoabdominal aortic aneurysm surgical repair is often complicated by postoperative acute kidney injury. The aim was to evaluate early renal injury influence on long-term renal function.

Methods: All type IV thoracoabdominal surgical repair performed between January 2000 and January 2014 in our tertiary hospital were included in this retrospective observational study. All procedures were performed through a retroperitoneal approach with at least suprarenal aortic cross-clamping. Cold Ringer Lactate was used to perfuse the kidneys. Serum creatinine (Scr.) and glomerular filtration rate (GFR) were recorded preoperatively, daily until discharge and at least annually during follow-up. Postoperative renal dysfunction was classified using the RIFLE score. Predictors of long-term renal decline were identified by logistic regression and a Cox model.

Results: Of total, 80 patients were included. Aortic clamping level was suprarenal (10%), supramesenteric (37%) or supracoeliac (53%). Ischemic durations were 29 ± 9 min for the gastrointestinal tract and the right kidney, 54 ± 28 min for the left kidney. Three patients died postoperatively. At discharge, 31 (38.8%) patients did not have a postoperative renal impairment (RIFLE-), compared with 49 (61.2%) who had a renal dysfunction (RIFLE+). GFR was 89 ± 29 ml/min vs 68 ± 37 ml/min, respectively (P < 0.01). In the RIFLE + group, Scr. was increased by x1.5 (Risk) for 22 patients, x2 (Injury) for 19 patients, and ×3 (Failure) for 8 patients. Mean follow-up was 59 months. Eighteen patients died, and 2 patients started permanent dialysis at 46 and 118 months during follow-up. The only predictive factor of long-term GFR degradation was a postoperative GFR below 45 ml/min (OR: 16.5; 95%; P < 0.001).

Conclusions: Postoperative renal dysfunction was a frequent complication, associated with long-term renal function degradation.
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http://dx.doi.org/10.1016/j.avsg.2020.04.072DOI Listing
October 2020

Peritoneal Carcinomatosis Risk and Long-Term Survival Following Hepatectomy for Spontaneous Hepatocellular Carcinoma Rupture: Results of a Multicenter French Study (FRENCH-AFC).

Ann Surg Oncol 2020 Sep 13;27(9):3383-3392. Epub 2020 Apr 13.

Department of Digestive Surgery, Hôpital Charles Nicolle, Rouen University Hospital, Rouen Cedex, France.

Background: Spontaneous rupture of hepatocellular carcinoma (HCC) remains a life-threatening complication, with a reported mortality rate of between 16 and 30% and an incidence rate of approximately 3% in Europe. Survival data and risk factors after ruptured HCC are lacking, especially for peritoneal metastasis (PM).

Objectives: The aims of this study were to evaluate the pattern of recurrence and mortality after hepatectomy for ruptured HCC, and to focus on PM.

Methods: We retrospectively reviewed the files of patients admitted to 14 French surgical centers for spontaneous rupture of HCC between May 2000 and May 2012.

Results: Overall, 135 patients were included in this study. The median disease-free survival and overall survival (OS) rates were 16.1 (11.0-21.1) and 28.7 (26.0-31.5) months, respectively, and the median follow-up period was 29 months. At last follow-up, recurrences were observed in 65.1% of patients (n = 88). The overall rate of PM following ruptured HCC was 12% (n = 16). Surgical management of PM was performed for six patients, with a median OS of 36.6 months. An α-fetoprotein level > 30 ng/mL (p = 0.0009), tumor size at rupture > 70 mm (p = 0.0009), and vascular involvement (p < 0.0001) were found to be independently associated with an increased likelihood of recurrence. No risk factor for PM was observed.

Conclusion: This large-cohort French study confirmed that 12% of patients had PM after ruptured HCC. A curative approach may be an option for highly selected patients with exclusive PD because of the survival benefit it could provide.
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http://dx.doi.org/10.1245/s10434-020-08442-5DOI Listing
September 2020

Randomised phase II trial evaluating the safety of peripherally inserted catheters versus implanted port catheters during adjuvant chemotherapy in patients with early breast cancer.

Eur J Cancer 2020 02 10;126:116-124. Epub 2020 Jan 10.

Department of Medical Oncology, Centre Henri Becquerel, Rouen, France; Department of Digestive Oncology, Rouen University Hospital, Rouen, France.

Background: Both peripherally inserted central catheters (PICCs) and implanted port catheters (PORTs) are used for adjuvant chemotherapy (ACT) administration in patients with early breast cancer (EBC). We aimed to compare the safety between PICCs and PORTs in this setting.

Patients And Methods: This monocentric phase II randomised trial (NCT02095743) included patients with EBC who were eligible for ACT. Patients with curative anticoagulation therapy were excluded. The primary objective was to identify which device has a lower probability of catheter-related significant adverse events (CR-SAEs) within the 35 weeks after device implantation. The secondary objective was to evaluate quality of life (QoL) and patient satisfaction.

Results: From February 2014 to May 2018, 256 patients were included, and 253 (99%) were analysed. Overall, 31 patients (12.2%) experienced CR-SAEs, which mainly included thromboembolic events. In an intention-to-treat analysis, the probability that a CR-SAE would occur was 7.8% (10 events) with PORTs versus 16.6% (21 events) with PICCs (hazard ratio [HR] = 2.2 [1.03-4.62], P = 0.036). In a per-protocol analysis, PICCs were also associated with a higher risk of CR-SAEs than PORTs (HR = 2.82 [1.26-6.25], P = 0.007). Regarding the secondary objectives, if there was no difference in QoL between the arms, then significantly more discomfort was reported among patients with PICCs than among patients with PORTs (P = 0.002 after implantation and P < 0.001 at mid-treatment or at the end of treatment).

Conclusions: CR-SAEs in patients with EBC are frequent but rarely impact the ACT process. Compared with PORTs, PICCs are associated with a significantly higher risk of CR-SAEs and more discomfort. PORTs should be preferred for ACT administration in patients with EBC.
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http://dx.doi.org/10.1016/j.ejca.2019.11.022DOI Listing
February 2020

Excision versus colorectal resection in deep endometriosis infiltrating the rectum: 5-year follow-up of patients enrolled in a randomized controlled trial.

Hum Reprod 2019 12;34(12):2362-2371

Department of Public Health and Management, Carol Davila University of Medicine and Pharmacy Bucharest, Romania.

Study Question: Is there a difference in functional outcomes and recurrence rate between conservative versus radical rectal surgery in patients with large deep endometriosis infiltrating the rectum 5 years postoperatively?

Summary Answer: No evidence was found that long-term outcomes differed when nodule excision was compared to rectal resection for deeply invasive endometriosis involving the bowel.

What Is Known Already: Functional outcomes of nodule excision and rectal resection for deeply invasive endometriosis involving the bowel are comparable 2 years after surgery. Despite numerous previously reported case series enrolling patients managed for colorectal endometriosis, long-term data remain scarce in the literature.

Study Design, Size, Duration: From March 2011 to August 2013, we performed a two-arm randomized trial, enrolling 60 patients with deep endometriosis infiltrating the rectum up to 15 cm from the anus, measuring >20 mm in length, involving at least the muscular layer in depth, and up to 50% of rectal circumference. Among them, 55 women were enrolled at one tertial referral centre in endometriosis, using a randomization list drawn up separately for this centre. Institute review board approval was obtained to continue follow-up to 10 years postoperatively. One patient requested to stop the follow-up 2 years after surgery.

Participants/materials, Setting, Methods: Patients underwent either nodule excision by shaving or disc excision, or segmental resection. Randomization was performed preoperatively using sequentially numbered, opaque, sealed envelopes, and patients were informed of randomization results. The primary endpoint was the proportion of patients experiencing one of the following symptoms: constipation (1 stool/>5 consecutive days), frequent bowel movements (≥3 stools/day), anal incontinence, dysuria or bladder atony requiring self-catheterization 24 months postoperatively. Secondary endpoints were values taken from the Knowles-Eccersley-Scott-symptom questionnaire (KESS), the gastrointestinal quality of life index (GIQLI), the Wexner scale, the urinary symptom profile (USP) and the Short Form 36 Health Survey (SF36).

Main Results And The Role Of Chance: Fifty-five patients were enrolled. Among the 27 patients in the excision arm, two were converted to segmental resection (7.4%). One patient managed by segmental resection withdrew from the study 2 years postoperatively, presuming that associated pain of other aetiologies may have jeopardized the outcomes. The 5 year-recurrence rate for excision and resection was 3.7% versus 0% (P = 1), respectively. For excision and resection, the primary endpoint was present in 44.4% versus 60.7% of patients (P = 0.29), respectively, while 55.6% versus 53.6% of patients subjectively reported normal bowel movements (P = 1). An intention-to-treat comparison of overall KESS, GIQLI, Wexner, USP and SF36 scores did not reveal significant differences between the two arms 5 years postoperatively. Statistically significant improvement was observed shortly after surgery with no further improvement or impairment recorded 1-5 years postoperatively. During the 5-year follow-up, additional surgical procedures were performed in 25.9% versus 28.6% of patients who had undergone excision or resection (P = 0.80), respectively.

Limitations, Reasons For Caution: The presumption of a 40% difference concerning postoperative functional outcomes in favour of nodule excision resulted in a lack of power for demonstration of the primary endpoint difference.

Wider Implications Of The Findings: Five-year follow-up data do not show statistically significant differences between conservative and radical rectal surgery for long-term functional digestive and urinary outcomes in this specific population of women with large involvement of the rectum.

Study Funding/competing Interest(s): No specific funding was received. Patient enrolment and follow-up until 2 years postoperatively was supported by a grant from the clinical research programme for hospitals in France. The authors declare no competing interests related to this study.

Trial Registration Number: This randomized study is registered with ClinicalTrials.gov, number NCT01291576.

Trial Registration Date: 31 January 2011.

Date Of First Patient’s Enrolment: 7 March 2011.
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http://dx.doi.org/10.1093/humrep/dez217DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6936722PMC
December 2019

Baseline severe constipation negatively impacts functional outcomes of surgery for deep endometriosis infiltrating the rectum: Results of the ENDORE randomized trial.

J Gynecol Obstet Hum Reprod 2019 Oct 19;48(8):625-629. Epub 2019 Mar 19.

Department of Surgery, Rouen University Hospital, 76031 Rouen, France.

Background: Predictive factors of functional outcomes after the surgery of rectal endometriosis are not well identified. Our recent randomized trial did not find significant differences between functional outcomes in patients managed by radical or conservative rectal surgery.

Objective: To identify preoperative factors which determine functional outcomes of surgery in patients with rectal endometriosis.

Study Design: We performed a cohort study on the population of a 2-arm randomised trial, from March 2011 to August 2013. Patients were enrolled in three French university hospitals and had either conservative surgery by shaving or disc excision, or radical rectal surgery by segmental resection. The primary endpoint was the proportion of patients experiencing one of the following symptoms: constipation, frequent bowel movements, anal incontinence, dysuria or bladder atony requiring self-catheterisation 24 months postoperatively. Secondary endpoints were the values of the Knowles-Eccersley-Scott-Symptom Questionnaire (KESS), the Gastrointestinal Quality of Life Index (GIQLI), the Wexner scale, the Urinary Symptom Profile (USP) and the Short Form 36 Health Survey (SF36). A logistic regression model based on backward selection was used to screen for baseline factors that could impact the primary endpoint. A generalized estimating equations model for repeated measures was used to assess whether a trend could be observed over the follow-up period as regards gastrointestinal and quality of life scores.

Results: 60 patients with deep endometriosis infiltrating the rectum were managed by conservative surgery (27 cases) and segmental colorectal resection (33 cases). The primary endpoint was recorded in 26 patients (48.1% for conservative surgery vs. 39.4% for radical surgery, OR = 0.70, 95% CI 0.22-2.21). There was a significant improvement in values of all gastrointestinal, quality of life and urinary scores after surgery. Comparing patients with KESS scores < 10 (reference) to those with scores between 10 and 17 (OR = 2.1, 95%CI 0.4-12.2), as well as those with scores >17 (OR = 11.1, 95%CI 2.2-20.5), revealed that the odds to record the primary endpoint are significantly higher in the latter group. Trend analyses suggest that the odds of an elevated KESS score are significantly higher at baseline than at 6 months, but significantly lower after 12 months.

Conclusions: Patients with severe preoperative constipation are less likely to achieve normal bowel movements after surgery for rectal endometriosis, using either radical or conservative rectal procedures.
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http://dx.doi.org/10.1016/j.jogoh.2019.03.013DOI Listing
October 2019

Impact of prehabilitation on morbidity and mortality after pulmonary lobectomy by minimally invasive surgery: a cohort study.

J Thorac Dis 2018 Apr;10(4):2240-2248

Normandie Univ, UNIROUEN, INSERM U1096, Rouen University Hospital, Rouen, France.

Background: Thoracic surgery is currently the optimal treatment for non-small cell lung cancer (NSCLC). However, it may be responsible for numerous postoperative complications and is often used in patients with multi co morbidities. In recent years, the optimization of a patient's physical capacity before surgery has been the subject of several studies. The objective of this study was to determine whether participation in a prehabilitation program would improve outcomes after surgery and lower morbidity according to the Clavien-Dindo classification.

Methods: This retrospective cohort study was performed between 1st January 2014 and 31st January 2016 at Rouen University Hospital. All adult patients with NSCLC (IIIa or <) who had pulmonary lobectomy by minimally invasive surgery and cardiopulmonary exercise testing [CPET (VO2max ≤20 mL/min/kg)] were included.

Results: The cohort included 38 patients. Two groups were formed: one group with prehabilitation (n=19) and one group without prehabilitation (n=19). Four patients were not included leaving 34 patients for the final analysis. Most patients with a Clavien-Dindo grade of ≤2 had received prehabilitation compared to patients who had not received prehabilitation, respectively 17/19 8/15; P=0.0252. Patients who had received prehabilitation had fewer postoperative complications than patients who had not received prehabilitation, respectively 8/19 12/15; P=0.0382.

Conclusions: We have shown that prehabilitation has a positive impact on the occurrence and severity of postoperative complications after pulmonary lobectomy by minimally invasive surgery. Further studies conducted in larger populations are warranted to confirm these results.
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http://dx.doi.org/10.21037/jtd.2018.03.161DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5949464PMC
April 2018

Conservative surgery versus colorectal resection in deep endometriosis infiltrating the rectum: a randomized trial.

Hum Reprod 2018 01;33(1):47-57

Department of Surgery, Rouen University Hospital, 76031 Rouen, France.

Study Question: Is there a difference in functional outcome between conservative versus radical rectal surgery in patients with large deep endometriosis infiltrating the rectum 2 years postoperatively?

Summary Answer: No evidence was found that functional outcomes differed when conservative surgery was compared to radical rectal surgery for deeply invasive endometriosis involving the bowel.

What Is Known Already: Adopting a conservative approach to the surgical management of deep endometriosis infiltrating the rectum, by employing shaving or disc excision, appears to yield improved digestive functional outcomes. However, previous comparative studies were not randomized, introducing a possible bias regarding the presumed superiority of conservative techniques due to the inclusion of patients with more severe deep endometriosis who underwent colorectal resection.

Study Design Size, Duration: From March 2011 to August 2013, we performed a 2-arm randomized trial, enroling 60 patients with deep endometriosis infiltrating the rectum up to 15 cm from the anus, measuring more than 20 mm in length, involving at least the muscular layer in depth and up to 50% of rectal circumference. No women were lost to follow-up.

Participants/materials, Setting, Methods: Patients were enroled in three French university hospitals and had either conservative surgery, by shaving or disc excision, or radical rectal surgery, by segmental resection. Randomization was performed preoperatively using sequentially numbered, opaque, sealed envelopes, and patients were informed of the results of randomization. The primary endpoint was the proportion of patients experiencing one of the following symptoms: constipation (1 stool/>5 consecutive days), frequent bowel movements (≥3 stools/day), defecation pain, anal incontinence, dysuria or bladder atony requiring self-catheterization 24 months postoperatively. Secondary endpoints were the values of the Visual Analog Scale (VAS), Knowles-Eccersley-Scott-Symptom Questionnaire (KESS), the Gastrointestinal Quality of Life Index (GIQLI), the Wexner scale, the Urinary Symptom Profile (USP) and the Short Form 36 Health Survey (SF36).

Main Results And The Role Of Chance: A total of 60 patients were enroled. Among the 27 patients in the conservative surgery arm, two were converted to segmental resection (7.4%). In each group, 13 presented with at least one functional problem at 24 months after surgery (48.1 versus 39.4%, OR = 0.70, 95% CI 0.22-2.21). The intention-to-treat comparison of the overall scores on KESS, GIQLI, Wexner, USP and SF36 did not reveal significant differences between the two arms. Segmental resection was associated with a significant risk of bowel stenosis.

Limitations Reasons For Caution: The inclusion of only large infiltrations of the rectum does not allow the extrapolation of conclusions to small nodules of <20 mm in length. The presumption of a 40% difference favourable to conservative surgery in terms of postoperative functional outcomes resulted in a lack of power to demonstrate a difference for the primary endpoint.

Wider Implications Of The Findings: Conservative surgery is feasible in patients managed for large deep rectal endometriosis. The trial does not show a statistically significant superiority of conservative surgery for mid-term functional digestive and urinary outcomes in this specific population of women with large involvement of the rectum. There is a higher risk of rectal stenosis after segmental resection, requiring additional endoscopic or surgical procedures.

Study Funding/competing Interest(s): This work was supported by a grant from the clinical research programme for hospitals (PHRC) in France. The authors declare no competing interests related to this study.

Trial Registration Number: This study is registered with ClinicalTrials.gov, number NCT 01291576.

Trial Registration Date: 31 January 2011.

Date Of First Patient’s Enrolment: 7 March 2011.
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http://dx.doi.org/10.1093/humrep/dex336DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5850309PMC
January 2018

Bleeding Recurrence and Mortality Following Interventional Management of Spontaneous HCC Rupture: Results of a Multicenter European Study.

World J Surg 2018 01;42(1):225-232

Department of General Surgery and Liver Transplantation, APHM, Hôpital de la Conception, Marseille University Hospital, Marseille, France.

Background: The incidence of spontaneous rupture of hepatocellular carcinoma (HCC) is low in Europe, at less than 3%. HCC rupture remains a life-threatening complication, with mortality reported between 16 and 30%. The risk of bleeding recurrence has never been clearly evaluated in such clinical situation. The objectives of this study were to evaluate the current risk of mortality related to HCC rupture and to focus on the risk of bleeding recurrence following interventional management.

Methods: All patients admitted to 14 French-Italian surgical centers for spontaneous rupture of HCC between May 2000 and May 2012 were retrospectively included. Clinical data, imaging features, relevant laboratory data, treatment strategies, and prognoses were analyzed.

Results: Overall, 58 of the 138 included patients (42%) had cirrhosis. Thirty-five patients (25%) presented with hemorrhagic shock, and 19% with organ(s) dysfunction. Bleeding control was obtained by interventional hemostasis, emergency liver resection, and conservative medical management in 86 (62%), 24 (18%), and 21 (15%) patients, respectively. Best supportive care was chosen for 7 (5%) patients. The mortality rate following rupture was 24%. The bleeding recurrence rate was 22% with related mortality of 52%. In multivariate analysis, a bilirubin level >17 micromol/L (HR 3.768; p = 0.006), bleeding recurrence (HR 5.400; p < 0.0001), and ICU admission after initial management (HR 8.199; p < 0.0001) were associated with in-hospital mortality.

Conclusion: This European, multicenter, large-cohort study confirmed that the prognosis of ruptured HCC is poor with an overall mortality rate of 24%, despite important advances in endovascular techniques. Overall, the rate of bleeding recurrence was more than 20%, with a related high risk of mortality.
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http://dx.doi.org/10.1007/s00268-017-4163-8DOI Listing
January 2018

The Interest of Performing "On-Demand Chest X-rays" after Lung Resection by Minimally Invasive Surgery.

Thorac Cardiovasc Surg 2017 Oct 11;65(7):572-580. Epub 2017 Apr 11.

Unit of Thoracic Surgery, University Hospital of Rouen, Rouen, France.

 There is a lack of consensus in hospital centers regarding costly daily routine chest X-rays after lung resection by minimally invasive surgery. Indeed, there is no evidence that performing daily chest X-rays prevents postoperative complications. Our objective was to compare chest X-rays performed on demand when there was clinical suspicion of postoperative complications and chest X-rays performed systematically in daily routine practice.  This prospective single-center study compared 55 patients who had on-demand chest X-rays and patients in the literature who had daily routine chest X-rays. Our primary evaluation criterion was length of hospitalization.  The length of hospitalization was 5.3 ± 3.3 days for patients who had on-demand X-rays, compared with 4 to 9.7 days for patients who had daily routine X-rays. Time to chest tube removal (4.34 days), overall complication rate (27.2%), reoperation rate (3.6%), and mortality rate (1.8%) were comparable to those in the literature. On average, our patients only had 1.22 ± 1.8 on-demand X-rays, compared with 3.3 X-rays if daily routine protocol had been applied. Patients with complications had more X-rays (3.4 ± 1.8) than patients without complications (0.4 ± 0.7).  On-demand chest X-rays do not seem to delay the diagnosis of postoperative complications or increase morbidity-mortality rates. Performing on-demand chest X-rays could not only simplify surgical practice but also have a positive impact on health care expenses. However, a broader randomized study is warranted to validate this work and ultimately lead to national consensus.
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http://dx.doi.org/10.1055/s-0037-1599793DOI Listing
October 2017

Maintenance nifedipine therapy for preterm symptomatic placenta previa: A randomized, multicenter, double-blind, placebo-controlled trial.

PLoS One 2017 23;12(3):e0173717. Epub 2017 Mar 23.

Inserm U657, University of Rouen and Biostatistics, Rouen, France.

Objective: To assess the impact of maintenance nifedipine therapy on pregnancy duration in women with preterm placenta previa bleeding.

Methods: PPADAL was a randomized, double-blind, placebo-controlled trial conducted between 05/2008 and 05/2012 in five French hospitals. The trial included 109 women, aged ≥ 18 years, with at least one episode of placenta previa bleeding, intact membranes and no other pregnancy complication, at gestational age 24 to 34 weeks and after 48 hours of complete acute tocolysis. Women were randomly allocated to receive either 20 mg of slow-release nifedipine three times daily (n = 54) or placebo (n = 55) until 36 + 6 weeks of gestation. The primary outcome for the trial was length of pregnancy measured in days after enrolment. Main secondary outcomes were rates of recurrent bleeding, cesarean delivery due to hemorrhage, blood transfusion, maternal side effects, gestational age at delivery and adverse perinatal outcomes (perinatal death, chronic lung disease, neonatal sepsis, intraventricular hemorrhage > grade 2, perventricular leukomalacia > grade 1, or necrotizing enterocolitis). Analysis was by intention to treat.

Results: Mean (SD) prolongation of pregnancy was not different between the nifedipine (n = 54) and the placebo (n = 55) group; 42.5 days ± 23.8 versus 44.2 days ± 24.5, p = 0.70. Cesarean due to hemorrhage performed before 37 weeks occurred more frequently in the nifedipine group in comparison with the placebo group (RR, 1.66; 95% confidence interval, 1.05-2.72). Adverse perinatal outcomes were comparable between groups; 3.8% for nifedipine versus 5.5% for placebo (relative risk, 0.52; 95% confidence interval 0.10-2.61). No maternal mortality or perinatal death occurred.

Conclusion: Maintenance oral nifedipine neither prolongs duration of pregnancy nor improves maternal or perinatal outcomes.

Trial Registration: ClinicalTrials.gov NCT00620724.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0173717PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5363821PMC
August 2017

Excess Body Mass Index Loss at 3 Months: A Predictive Factor of Long-Term Result after Sleeve Gastrectomy.

J Obes 2017 29;2017:2107157. Epub 2017 Jan 29.

Department of Digestive Surgery, Rouen University Hospital, 1 rue de Germont, 76031 Rouen, France.

Laparoscopic Sleeve Gastrectomy (SG) is considered as successful if the percentage of Excess Body Mass Index Loss (% EBMIL) remains constant over 50% with long-term follow-up. The aim of this study was to evaluate whether early % EBMIL was predictive of success after SG. This retrospective study included patients who had SG with two years of follow-up. Patients had follow-up appointments at 3 (M3), 6, 12, and 24 months (M24). Data as weight and Body Mass Index (BMI) were collected systematically. We estimated the % EBMIL necessary to establish a correlation between M3 and M24 compared to % EBMIL speeds and calculated a limit value of % EBMIL predictive of success. Data at operative time, M3, and M24 were available for 128 patients. Pearson test showed a correlation between % EBMIL at M3 and that at M24 ( = 0.74; < 0.0001). % EBMIL speed between surgery and M3 ( = 0.0011) was significant but not between M3 and M24. A linear regression analysis proved that % EBMIL over 20.1% at M3 ( < 0.0001) predicted a final % EBMIL over 50%. % EBMIL at M3 after SG is correlated with % EBMIL in the long term. % EBMIL speed was significant in the first 3 months. % EBMIL over 20.1% at M3 leads to the success of SG.
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http://dx.doi.org/10.1155/2017/2107157DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5303591PMC
September 2017

Use of water-soluble contrast medium (gastrografin) does not decrease the need for operative intervention nor the duration of hospital stay in uncomplicated acute adhesive small bowel obstruction? A multicenter, randomized, clinical trial (Adhesive Small Bowel Obstruction Study) and systematic review.

Surgery 2017 05 10;161(5):1315-1325. Epub 2017 Jan 10.

Digestive and Oncological Surgery Department, Amiens University Medical Center, Amiens, France; EA 4292, Jules Verne University of Picardy, Amiens, France; Clinical Research Center, Amiens University Medical Center, Amiens, France. Electronic address:

Background: This study evaluated the association between oral gastrografin administration and the need for operative intervention in patients with presumed adhesive small bowel obstruction.

Methods: Between October 2006 and August 2009, 242 patients with uncomplicated acute adhesive small bowel obstruction were included in a randomized, controlled trial (the Adhesive Small Bowel Obstruction Study, NCT00389116) and allocated to a gastrografin arm or a saline solution arm. The primary end point was the need for operative intervention within 48 hours of randomization. The secondary end points were the resection rate, the time interval between the initial computed tomography and operative intervention, the time interval between oral refeeding and discharge, risk factors for the failure of nonoperative management, in-hospital mortality, duration of stay, and recurrence or death after discharge. We performed a systematic review of the literature in order to evaluate the relationship between use of gastrografin as a diagnostic/therapeutic measure, the need for operative intervention, and the duration of stay.

Results: In the gastrografin and saline solution arms, the rate of operative intervention was 24% and 20%, respectively, the bowel resection rate was 8% and 4%, the time interval between the initial computed tomography and operative intervention, and the time interval between oral refeeding and discharge were similar in the 2 arms. Only age was identified as a potential risk factor for the failure of nonoperative management. The in-hospital mortality was 2.5%, the duration of stay was 3.8 days for patients in the gastrografin arm and 3.5 days for those in the saline solution arm (P = .19), and the recurrence rate of adhesive small bowel obstruction was 7%. These results and those of 10 published studies suggest that gastrografin did not decrease either the rate of operative intervention (21% in the saline solution arm vs 26% in the gastrografin arm) or the number of days from the initial computed tomography to discharge (3.5 vs 3.5; P = NS for both).

Conclusion: The results of the present study and those of our systematic review suggest that gastrografin administration is of no benefit in patients with adhesive small bowel obstruction.
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http://dx.doi.org/10.1016/j.surg.2016.11.026DOI Listing
May 2017

Kinetics, prognostic and predictive values of ESR1 circulating mutations in metastatic breast cancer patients progressing on aromatase inhibitor.

Oncotarget 2016 11;7(46):74448-74459

Department of Medical Oncology, Henri Becquerel Centre, Rouen, France.

Purpose: To assess the prognostic and predictive value of circulating ESR1 mutation and its kinetics before and after progression on aromatase inhibitor (AI) treatment.

Patients And Methods: ESR1 circulating D538G and Y537S/N/C mutations were retrospectively analyzed by digital droplet PCR after first-line AI failure in patients treated consecutively from 2010 to 2012 for hormone receptor-positive metastatic breast cancer. Progression-free survival (PFS) and overall survival (OS) were analyzed according to circulating mutational status and subsequent lines of treatment. The kinetics of ESR1 mutation before (3 and 6 months) and after (3 months) AI progression were determined in the available archive plasmas.

Results: Circulating ESR1 mutations were found at AI progression in 44/144 patients included (30.6%). Median follow-up from AI initiation was 40 months (range 4-94). The median OS was decreased in patients with circulating ESR1 mutation than in patients without mutation (15.5 versus 23.8 months, P=0.0006). The median PFS was also significantly decreased in patients with ESR1 mutation than in patients without mutation (5.9 vs 7 months, P=0.002). After AI failure, there was no difference in outcome for patients receiving chemotherapy (n = 58) versus non-AI endocrine therapy (n=51) in patients with and without ESR1 mutation. ESR1 circulating mutations were detectable in 75% of all cases before AI progression, whereas the kinetics 3 months after progression did not correlate with outcome.

Conclusion: ESR1 circulating mutations are independent risk factors for poor outcome after AI failure, and are frequently detectable before clinical progression. Interventional studies based on ESR1 circulating status are warranted.
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http://dx.doi.org/10.18632/oncotarget.12950DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5342678PMC
November 2016

No Evidence That Azathioprine Increases Risk of Cholangiocarcinoma in Patients With Primary Sclerosing Cholangitis.

Clin Gastroenterol Hepatol 2016 12 10;14(12):1806-1812. Epub 2016 Aug 10.

1st Department of Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. Electronic address:

Background & Aims: Patients with primary sclerosing cholangitis (PSC) are at increased risk for developing cholangiocarcinoma (CCA). Patients with PSC also can have inflammatory bowel diseases (IBDs) or features of autoimmune hepatitis (AIH), and therefore are treated with azathioprine. Azathioprine has been associated with an increased risk for malignancy, therefore we investigated whether azathioprine use affects the risk of CCA in persons with PSC.

Methods: We performed a retrospective study of well-defined patients with PSC using data collected from 3 large-volume, tertiary care centers in Germany and Norway. We analyzed data from 638 patients (70% men; 5900 patient-years of follow-up evaluation); 91 patients had received azathioprine therapy (considered to be effective at 90 days after first intake). Risk analysis was performed using the Cox proportional hazard model when risks competing with study end points were present.

Results: Of patients who received azathioprine treatment, 3.3% developed CCA, compared with 6.8% of patients without azathioprine treatment. However, azathioprine did not significantly affect the risk for CCA (hazard ratio, 0.96; 95% confidence interval, 0.29-3.13; P = .94). The only factor associated with an increased risk of CCA was age 35 years or older at PSC diagnosis (hazard ratio, 3.87; 95% confidence interval, 1.96-7.67; P < .01). Patient sex, concomitant IBD, or AIH did not affect the risk of CCA. Overall, the cumulative 10-year incidence of CCA was 4.6% and the cumulative 15-year incidence was 7.7%.

Conclusions: A retrospective analysis of patients with PSC treated at tertiary centers in Europe found no evidence that azathioprine significantly affects the risk of CCA. Azathioprine therefore should not be withheld from patients with PSC and concomitant IBD and/or AIH.
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http://dx.doi.org/10.1016/j.cgh.2016.07.032DOI Listing
December 2016

Usefulness of video-laryngoscopy with the Airway Scope for intubation performance and learning: an experimental manikin controlled study.

Ann Intensive Care 2016 Dec 26;6(1):83. Epub 2016 Aug 26.

Department of Medical Intensive Care, Rouen University Hospital, Rouen Cedex, France.

Background: Different video-laryngoscopes (VDLs) for endotracheal intubation (ETI) have recently been developed. We compared the performance of the VDL Airway Scope (AWS) with the direct laryngoscopy by Macintosh (DLM) for ETI success, time and learning.

Methods: We performed an experimental manikin controlled study. Twenty experienced (experts) and 40 inexperienced operators (novices) for DLM-ETI were enrolled. None of them had experience with the use of AWS-VDL. Novices were assigned to start learning with DLM or AWS, and two sub-groups of 20 novices were formed. Experts group constituted the control group. Each participant performed 10 ETI attempts with each device on the same standard manikin. The primary endpoint was the ETI success probability. Secondary endpoints were ETI time, technical validity and qualitative evaluation for each technique. We also assessed the learning order and the successive attempts effects for these parameters.

Results: Overall, 1200 ETI attempts were performed. ETI success probability was higher with the AWS than with the DLM for all operators (98 vs. 81 %; p < 0.0001) and for experts compared to novices using devices in the same order (97 vs. 83 %; p = 0.0002). Overall ETI time was shorter with the AWS than with the DLM (13 vs. 20 s; p < 0.0001) and for experts compared to novices using devices in the same order (11 vs. 21 s; p < 0.0001). Among novices, those starting learning with AWS had higher ETI success probability (89 vs. 83 %; p = 0.03) and shorter ETI time (18 vs. 21 s; p = 0.02). Technical validity was found better with the AWS than DLM for all operators. Novices expressed global satisfaction and device preference for the AWS, whereas experts were indifferent.

Conclusions: AWS-VDL permits faster, easier and more reliable ETI compared to the DLM whatever the previous airway ETI experience and could be a useful device for DLM-ETI learning.
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http://dx.doi.org/10.1186/s13613-016-0182-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5001963PMC
December 2016

Adjuvant I-131 Lipiodol After Resection or Radiofrequency Ablation for Hepatocellular Carcinoma.

World J Surg 2016 Aug;40(8):1941-50

Department of Digestive Surgery, Rouen University Hospital-Charles Nicolle, Rouen, France.

Background And Objectives: High rates of recurrence have been observed after curative treatment for hepatocellular carcinoma (HCC). The main aim of this study was to establish the influence of adjuvant transarterial radioembolization-based I-131 lipiodol on survival and recurrence.

Methods: Between 2004 and 2010, 38 patients were treated with adjuvant I-131 lipiodol therapy, at a dosage of 2220 MBq, within 4 months after surgery. This treated cohort was compared to a control cohort consisting of 42 consecutive patients operated prior to the time the I-131 lipiodol treatment became available.

Results: Recurrence-free survival in the control and in the I-131 lipiodol cohort was 12.6 and 18.7 months, respectively (HR = 1.871, p = 0.025). At 2 and 5 years, the cumulative incidence of a first recurrence or death was, respectively, 50 % and 61 % in the treated cohort versus 69 % and 74 % in the control cohort. Median overall survival was 55 and 29 months, respectively (p = 0.051). Among patients with a recurrence at 2 years, more patients had already experienced such recurrence at 1 year in the control cohort (70 % vs 33 %, p = 0.014).

Conclusions: Adjuvant I-131 lipiodol improves disease-free survival in patients with HCC.
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http://dx.doi.org/10.1007/s00268-016-3502-5DOI Listing
August 2016

Perioperative outcomes of video- and robot-assisted segmentectomies.

Asian Cardiovasc Thorac Ann 2016 Feb 12;24(2):145-51. Epub 2016 Jan 12.

Department of General and Thoracic Surgery, Rouen University Hospital, Rouen, France.

Objective: Video-assisted thoracic surgery appears to be technically difficult for segmentectomy. Conversely, robotic surgery could facilitate the performance of segmentectomy. The aim of this study was to compare the early results of video- and robot-assisted segmentectomies.

Methods: Data were collected prospectively on videothoracoscopy from 2010 and on robotic procedures from 2013. Fifty-one patients who were candidates for minimally invasive segmentectomy were included in the study. Perioperative outcomes of video-assisted and robotic segmentectomies were compared.

Results: The minimally invasive segmentectomies included 32 video- and 16 robot-assisted procedures; 3 segmentectomies (2 video-assisted and 1 robot-assisted) were converted to lobectomies. Four conversions to thoracotomy were necessary for anatomical reason or arterial injury, with no uncontrolled bleeding in the robotic arm. There were 7 benign or infectious lesions, 9 pre-invasive lesions, 25 lung cancers, and 10 metastatic diseases. Patient characteristics, type of segment, conversion to thoracotomy, conversion to lobectomy, operative time, postoperative complications, chest tube duration, postoperative stay, and histology were similar in the video and robot groups. Estimated blood loss was significantly higher in the video group (100 vs. 50 mL, p = 0.028).

Conclusions: The morbidity rate of minimally invasive segmentectomy was low. The short-term results of video-assisted and robot-assisted segmentectomies were similar, and more data are required to show any advantages between the two techniques. Long-term oncologic outcomes are necessary to evaluate these new surgical practices.
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http://dx.doi.org/10.1177/0218492315627556DOI Listing
February 2016

Organotypic lung culture: A new model for studying ischemia and ex vivo perfusion in lung transplantation.

Exp Lung Res 2015 ;41(10):564-75

b Inserm U1096, Rouen University , France.

Aim: Donors after cardiac death (DCD) in lung transplantation is considered as a solution for organ shortage. However, it is characterized by warm ischemic period, which could be involved in severe Ischemia-Reperfusion lesion (IR) with early graft dysfunction. We describe a new hybrid model combining in vivo ischemia followed by in vitro reoxygenation using organ-specific culture.

Material And Methods: A hybrid model using in vivo ischemic period followed by in vitro lung slice reoxygenation was set up in rat to mimic DCD in lung transplantation with in vitro perfusion. Different markers (bioenergetics, oxidant stress assays, and histology) were measured to evaluate the viability of lung tissue after different ischemic times (I-0, I-1, I-2, I-4, I-15 hours) and reoxygenation times (R-0, R-1, R-4, R-24 hours).

Results: No differences were found in cell viability, ATP concentrations, extracellular LDH assays or histology, demonstrating extensive viability of up to 4 hours in lung tissue warm ischemia. We found oxidative stress mainly during the ischemic period with no burst at reoxygenation. Cytosolic anti-oxidant system was involved first (I-0,I-1,I-2) followed by mitochondrial anti-oxidant system for extensive ischemia (I-4). Histological features showed differences in this model of ischemia-reoxygenation between bronchial epithelium and lung parenchymal cells, with epithelium regeneration after 2 hours of warm ischemia and 24 hours of perfusion.

Conclusion: The results of our hybrid model experiment suggest extensive lung viability of up to 4 hours ischemia. Our model could be an interesting tool to evaluate ex vivo reconditioning techniques after different in vivo lung insults.
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http://dx.doi.org/10.3109/01902148.2015.1123328DOI Listing
September 2016

Criteria Used in Clinical Practice to Guide Immunosuppressive Treatment in Patients with Primary Sclerosing Cholangitis.

PLoS One 2015 21;10(10):e0140525. Epub 2015 Oct 21.

I. Department of Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Background & Aims: Current guidelines recommend immunosuppressive treatment (IT) in patients with primary sclerosing cholangitis (PSC) and elevated aminotransferase levels more than five times the upper limit of normal and elevated serum IgG-levels above twice the upper limit of normal. Since there is no evidence to support this recommendation, we aimed to assess the criteria that guided clinicians in clinical practice to initiate IT in patients with previously diagnosed PSC.

Methods: This is a retrospective analysis of 196 PSC patients from seven German hepatology centers, of whom 36 patients had received IT solely for their liver disease during the course of PSC. Analyses were carried out using methods for competing risks.

Results: A simplified autoimmune hepatitis (AIH) score >5 (HR of 36, p<0.0001) and a modified histological activity index (mHAI) greater than 3/18 points (HR 3.6, p = 0.0274) were associated with the initiation of IT during the course of PSC. Of note, PSC patients who subsequently received IT differed already at the time of PSC diagnosis from those patients, who did not receive IT during follow-up: they presented with increased levels of IgG (p = 0.004) and more frequently had clinical signs of cirrhosis (p = 0.0002).

Conclusions: This is the first study which investigates the parameters associated with IT in patients with PSC in clinical practice. A simplified AIH score >5 and a mHAI score >3, suggesting concomitant features of AIH, influenced the decision to introduce IT during the course of PSC. In German clinical practice, the cutoffs used to guide IT may be lower than recommended by current guidelines.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0140525PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4619354PMC
June 2016

¹⁸F-FDG-PET/CT Imaging in Patients with Febrile Neutropenia and Haematological Malignancies.

Anticancer Res 2015 May;35(5):2999-3005

Department of Haematology, Centre Henri Becquerel, Rouen, France

The aim of the present study was to assess the prevalence of hyper-metabolic infection sites revealed by fluorine-18 ((18)F) fluorodeoxyglucose (FDG) positron-emission tomography (PET) combined with computed tomography (CT) in patients with febrile neutropenia (FN). Forty-eight consecutive patients with haematological malignancies and persistent FN (temperature ≥ 38°C and neutrophil count <500 cells/μl for more than two days) as a consequence of intensive chemotherapy were prospectively included. Pathological FDG uptakes identified 31 foci of infections located in the lungs (n=15, 48.4 %), colon (n=4, 12.9%), pancreas (n=2, 6.5%), skin (n=3, 9.7%), ear-nose-throat area (n=5, 16.1%), central venous catheter tract (n=1, 3.2%) and gallbladder (n=1, 3.2%). These pathological FDG uptakes were observed in half of the 48 patients (n=24). Among the 38 patients with a clinical diagnosis of infection, 23 showed a pathological FDG uptake, resulting in a FDG-PET/CT sensitivity of 61% (95% CI, 43-76%). Our study confirmed the ability of FDG-PET/CT to diagnose infections in patients with persistent FN.
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May 2015

Robot-Assisted Thoracoscopic Surgery versus Video-Assisted Thoracoscopic Surgery for Lung Lobectomy: Can a Robotic Approach Improve Short-Term Outcomes and Operative Safety?

Thorac Cardiovasc Surg 2016 Jun 13;64(4):354-62. Epub 2015 Apr 13.

Department of Thoracic Surgery, Rouen University Hospital, Rouen, France.

Background Minimally invasive surgery has been recently recommended for treatment of early-stage non-small cell lung cancer. Despite the recent increase of robotic surgery, the place and potential advantages of the robot in thoracic surgery has not been well defined until now. Methods We reviewed our prospective database for retrospective comparison of our first 28 video-assisted thoracoscopic surgery lobectomies (V group) and our first 28 robotic lobectomies (R group). Results No significant difference was shown in median operative time between the two groups (185 vs. 190 minutes, p = 0.56). Median preincision time was significantly longer in the R group (80 vs. 60 minutes, P < 0.0001). The rate of emergency conversion for uncontrolled bleeding was lower in the R group (one vs. four). Median length of stay was comparable (6 days in the R group vs. 7 days in the V group, p = 0.4) with no significant difference in the rate of postoperative complications (eight Grade I in both groups, four Grade III or IV in the V group vs. six in the R group, according to the Clavien-Dindo classification, p = 0.93). No postoperative cardiac morbidity was observed in the R group. Median drainage time was similar (5 days, p = 0.78), with a rate of prolonged air leak slightly higher in the R group (25 vs. 17.8%, p = 0.74). Conclusion Perioperative outcomes are similar even in the learning period but robotic approach seems to offer more operative safety with fewer conversions for uncontrolled bleeding.
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http://dx.doi.org/10.1055/s-0035-1548733DOI Listing
June 2016

Association of occupational exposure with features of systemic sclerosis.

J Am Acad Dermatol 2015 Mar 10;72(3):456-64. Epub 2015 Jan 10.

Department of Internal Medicine, Centre Hospitalier Universitaire (CHU) Rouen, and Institut National de la Santé et de la Recherche Biomédicale (INSERM) Unit 905, University of Rouen Institut Fédératif Multidisciplinaire sur les Peptides (IFRMP), Institute for Biochemical Research, Rouen, France.

Background: Occupational exposure is reported as playing a substantial causative role in systemic sclerosis (SSc).

Objective: We sought to compare the characteristics of SSc in patients with and without occupational exposure to crystalline silica/solvents.

Methods: In all, 142 patients with SSc were enrolled in this prospective study. An expert committee performed blind evaluation of occupational exposure to crystalline silica/solvents.

Results: Patients exposed to crystalline silica more often exhibited: diffuse cutaneous SSc (P = .02), digital ulcers (P = .05), interstitial lung disease (P = .0004), myocardial dysfunction (P = .006), and cancer (P = .06). Patients exposed to solvents more frequently developed: diffuse cutaneous SSc (P = .001), digital ulcers (P = .01), interstitial lung disease (P = .02), myocardial dysfunction (P = .04), and cancer (P = .003); in addition, these patients were more frequently anti-Scl 70 positive and anticentromere negative. Under multivariate analysis, significant factors for SSc associated with exposure to silica/solvents were: male gender (odds ratio 19.31, 95% confidence interval 15.34-69.86), cancer (odds ratio 5.97, 95% confidence interval 1.55-23.01), and digital ulcers (odds ratio 2.42, 95% confidence interval 1.05-5.56).

Limitations: The cohort originated from a single geographic region.

Conclusion: Occupational exposure to crystalline silica/solvents is correlated with more severe forms of SSc characterized by: diffuse cutaneous involvement, interstitial lung disease, general microangiopathy (digital ulcers and myocardial dysfunction), and association with cancer. Occupational exposure should be systematically checked in all patients with SSc, as exposed patients seem to develop more severe forms of SSc.
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http://dx.doi.org/10.1016/j.jaad.2014.11.027DOI Listing
March 2015

Antimullerian hormone level and endometrioma ablation using plasma energy.

JSLS 2014 Jul-Sep;18(3)

Department of Gynecology and Obstetrics, University Hospital, Targu Mures, Romania.

Objective: To investigate the impact of ovarian endometrioma vaporization using plasma energy on antimullerian hormone (AMH) level.

Method: We report a prospective, noncomparative series (NCT01596985). Twenty-two patients with unilateral ovarian endometriomas≥30 mm, with no surgical antecedent and no ongoing pregnancy, underwent vaporization of ovarian endometriomas using plasma energy during the period of November 29, 2010 to November 28, 2012. We assessed AMH levels before surgery, 3 months postoperatively, and at the end of follow-up.

Results: The mean length of postoperative follow-up was 18.2±8 months. AMH level significantly varied through the 3 assessments performed in the study, as the mean values±SD were 3.9±2.6 ng/mL before the surgery, 2.3±1.1 ng/mL at 3 months, and 3.1±2.2 ng/mL at the end of the follow-up (P=.001). There was a significant increase from 3 months postoperatively to the end of follow-up (median change 0.7 ng/mL, P=.01). Seventy-one percent of patients had an AMH level>2 ng/mL at the end of the follow-up versus 76% before the surgery (P=1). During the postoperative follow-up, 11 patients tried to conceive, of whom 8 (73%) became pregnant.

Conclusions: The ablation of unilateral endometriomas is followed in a majority of cases by a significant decrease in AMH level 3 months after surgery. In subsequent months, this level progressively increases, raising questions about the real factors that impact postoperative ovarian AMH production.
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http://dx.doi.org/10.4293/JSLS.2014.00002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4208885PMC
February 2016

Single-source dual-energy CT angiography with reduced iodine load in patients referred for aortoiliofemoral evaluation before transcatheter aortic valve implantation: impact on image quality and radiation dose.

Eur Radiol 2014 Nov 25;24(11):2659-68. Epub 2014 Jun 25.

Department of Radiology, Rouen University Hospital, Cardiac MR/CT Unit, 1 Rue de Germont, 76031, Rouen CEDEX, France.

Objectives: To compare image quality and radiation dose of pre-transcatheter aortic valve implantation (TAVI) aortoiliofemoral CT angiography (AICTA) provided by standard vs. dual-energy mode with reduced iodine load protocols.

Methods: One hundred and sixty-one patients underwent a two-step CTA protocol before TAVI including cardiac CTA with injection of 65 mL of iodinated contrast agent (ICA), immediately followed by AICTA. From this second acquisition, the following three different patient groups were identified: Group 1: 52 patients with standard AICTA (60 mL ICA, 100 kVp, mA automodulation); Group 2: 48 patients with dual-energy AICTA with 50 % iodine load reduction (30 mL ICA, fast kVp switching, 600 mA); Group 3: 61 patients with an identical protocol to Group 2, but exposed to 375 mA. The qualitative/subjective image quality (13-point score) and quantitative/objective image quality (contrast attenuation and image noise) were evaluated. The radiation dose was recorded.

Results: There was no significant difference in non-diagnostic images between the three protocols. Contrast attenuation, signal-to-noise ratio and contrast-to-noise ratio were significantly higher, whereas noise was significantly lower in the standard protocol (all P < 0.05). The radiation dose was lower in the dual-energy protocol at 375 mA (P < 0.05).

Conclusions: Dual-energy AICTA before TAVI results in a reduction of iodine load while maintaining sufficient diagnostic information despite increased noise.

Key Points: • Dual-energy AICTA before TAVI results in a 50 % reduction of iodine load. •The reduction of iodine load maintains sufficient image quality despite increased noise. • Using 375 mA in dual-energy mode results in a reduction of radiation dose. • A high tube current setting (600 mA) should be used in overweight patients.
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http://dx.doi.org/10.1007/s00330-014-3263-1DOI Listing
November 2014

Low risk of hepatocellular carcinoma in patients with primary sclerosing cholangitis with cirrhosis.

Clin Gastroenterol Hepatol 2014 Oct 12;12(10):1733-8. Epub 2014 Feb 12.

First Department of Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. Electronic address:

Background & Aims: Primary sclerosing cholangitis (PSC) is associated with an increased risk of hepatobiliary malignancies. However, little is known about the incidence of hepatocellular carcinoma (HCC) among patients with PSC; current recommendations on screening these patients for HCC are conflicting. We investigated the risk of HCC in patients with PSC with cirrhosis.

Methods: We performed a retrospective study of patients with well-defined PSC from 2 large-volume tertiary care centers in Germany; data were collected from periods of up to 33 years. Liver cirrhosis was based on histology results or the presence of ascites, esophageal varices, or transient elastography values greater than 14 kPa. Statistical analysis was performed using the Kaplan-Meier method and the Cox proportional hazard model. Data from 509 patients (67% male), with a total of 4202 patients-years, were included in the final analysis.

Results: We identified 119 patients with cirrhosis. During 292 patient-years, none of these patients developed HCC. Most HCCs were identified incidentally at the time of liver transplantation. We therefore reviewed data on liver explants from 140 patients who underwent transplantation; none were found to contain HCC. In contrast to the low numbers of HCCs among patients with PSC, 35 patients developed cholangiocarcinoma, 3 patients developed gallbladder cancer, and 9 patients developed colorectal cancer.

Conclusions: Based on a retrospective analysis of more than 500 patients with PSC, we confirm their high risk for hepatobiliary malignancies. However, the risk of HCC, even among patients with cirrhosis, seems to be low--regular HCC surveillance may not be warranted.
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http://dx.doi.org/10.1016/j.cgh.2014.02.008DOI Listing
October 2014

Renal blood oxygenation level-dependent imaging: contribution of R2 to R2* values.

Invest Radiol 2013 Jul;48(7):501-8

NYU Langone Medical Center, Department of Radiology, New York, NY, USA.

Objectives: The aim of this study was to assess the impact of oral water and intravenous furosemide challenges on blood oxygenation level-dependent magnetic resonance imaging measurements in the kidney and to examine the contribution of R2 (=1/T2) to changes in R2* (=1/T2*).

Materials And Methods: This Health Insurance Portability and Accountability Act-compliant study had institutional review board approval, and written informed consent was obtained from all subjects. Nine healthy volunteers were imaged at 3 T on 2 visits. During each visit, a baseline fasting magnetic resonance acquisition was followed by a diuretic challenge: oral water load for the first visit and furosemide for the second. R2* and R2 values in the renal cortex and medulla were measured using multiple gradient echo and multiple spin echo sequences, respectively, and R2' values were computed as R2' = R2* - R2. Timed urinary output was also measured.

Results: Averaged across all subjects, the R2* response to furosemide was greater than to water and greater in the medulla than the cortex. The mean R2 responses exhibited the same trends but were uniformly smaller than the mean R2* responses. The peak changes in R2* and R2 appeared, on average, 10 to 14 minutes before peak urinary output. The median percentage contribution of R2 to R2* changes was 16% in the medulla after both challenges. In the cortex, the median contribution was 48% after water load and 58% after furosemide challenge.

Conclusions: The contributions of R2 to R2* changes after water load and furosemide challenge are not negligible, especially in the renal cortex. In routine clinical practice, R2* could be used alone as a rough surrogate for R2' in the medulla. However, in the cortex, both R2 and R2* should be measured to obtain accurate values of R2'.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5053024PMC
http://dx.doi.org/10.1097/RLI.0b013e3182823591DOI Listing
July 2013