Publications by authors named "Stefano Merigliano"

74 Publications

Multimodal treatment of radiation-induced esophageal cancer: Results of a case-matched comparative study from a single center.

Int J Surg 2022 Mar 18;99:106268. Epub 2022 Feb 18.

Center for Esophageal Diseases - Department of Surgical, Oncological and Gastroenterological Sciences - University of Padova, Padova, Italy.

Purpose: Radiation-induced esophageal cancer (RIEC) is a rare but severe late consequence of radiotherapy. The literature regarding this topic is predominately limited in describing the risk of this disease. Tumor behavior, treatment strategies, and prognosis of this cancer remain poorly defined.

Patients And Methods: We collected data of patients who were referred to our unit between 2000 and 2020 for RIEC. After tumor board discussion, upfront surgery or neoadjuvant therapy and surgery were indicated as the main treatment. Preoperative characteristics, long-term and short-term postoperative outcomes of RIEC patients were compared with a 1:1 clustering-matched cohort of patients affected by primary esophageal cancer (PEC).

Results: At pre-matching, 54 RIEC and 936 PEC patients were enrolled. The median time between primary irradiation and diagnosis of RIEC was 13.5 years, and the median primary radiation dose was 60 Gy. Compared to the unmatched cohort of PECs, RIEC patients were more frequently female (p = 0.0007), had earlier detection of disease (p = 0.03) and presented more frequently with upper esophageal cancers (p < 0.0001). Neoadjuvant treatment was used less frequently in RIEC patients (p < 0.0001). After matching, the 51 RIEC and 50 PEC patients showed comparable results in terms of exposure to neoadjuvant treatment, surgical radicality and survival outcomes. RIEC patients had more severe postoperative complications (p = 0.04) and a higher proportion of pulmonary complications (p = 0.04).

Conclusions: Curative treatments are feasible for RIEC. Neoadjuvant chemotherapy or chemoradiation can be used in this subgroup, treatment response and long-term outcomes are comparable to those of PEC. The risk of postoperative complications is probably related to the detrimental effect of primary irradiation on lung function.
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http://dx.doi.org/10.1016/j.ijsu.2022.106268DOI Listing
March 2022

Association of CLDN18 Protein Expression with Clinicopathological Features and Prognosis in Advanced Gastric and Gastroesophageal Junction Adenocarcinomas.

J Pers Med 2021 Oct 26;11(11). Epub 2021 Oct 26.

Surgical Pathology Unit, Department of Medicine (DIMED), University of Padua, 35122 Padua, Italy.

The tight junction protein claudin-18 (CLDN18), is often expressed in various cancer types including gastric (GC) and gastroesophageal adenocarcinomas (GECs). In the last years, the isoform CLDN18.2 emerged as a potential drug target in metastatic GCs, leading to the development of monoclonal antibodies against this protein. CLDN18.2 is the dominant isoform of CLDN18 in normal gastric and gastric cancer tissues. In this work, we evaluated the immunohistochemical (IHC) profile of CLDN18 and its correlation with clinical and histopathological features including p53, E-cadherin, MSH2, MSH6, MLH1, PMS2, HER2, EBER and PD-L1 combined positive score, in a large real-world and mono-institutional series of advanced GCs ( = 280) and GECs ( = 70). The association of IHC results with survival outcomes was also investigated. High membranous CLDN18 expression (2+ and 3+ intensity ≥75%) was found in 117/350 (33.4%) samples analyzed. CLDN18 expression correlated with age <70 ( = 0.0035), positive EBV status ( = 0.002), high stage (III, IV) at diagnosis ( = 0.003), peritoneal involvement ( < 0.001) and lower incidence of liver metastases ( = 0.013). CLDN18 did not correlate with overall survival. The predictive value of response of CLDN18 to targeted agents is under investigation in several clinical trials and further studies will be needed to select patients who could benefit from these therapies.
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http://dx.doi.org/10.3390/jpm11111095DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8624955PMC
October 2021

The ERG1A K Channel Is More Abundant in Muscle from Cancer Patients Than that from Healthy Humans.

Diagnostics (Basel) 2021 Oct 12;11(10). Epub 2021 Oct 12.

Anatomy Department, Southern Illinois University School of Medicine, Carbondale, IL 62902, USA.

Background: The potassium channel encoded by the (a) has been detected in the atrophying skeletal muscle of mice experiencing either muscle disuse or cancer cachexia and further evidenced to contribute to muscle deterioration by enhancing ubiquitin proteolysis; however, to our knowledge, ERG1A has not been reported in human skeletal muscle.

Methods And Results: Here, using immunohistochemistry, we detect ERG1A immunofluorescence in human skeletal muscle sarcolemma. Further, using single point brightness data, we report the detection of ERG1A immunofluorescence at low levels in the muscle sarcolemma of young adult humans and show that it trends toward greater levels (10.6%) in healthy aged adults. Interestingly, we detect ERG1A immunofluorescence at a statistically greater level (53.6%; < 0.05) in the skeletal muscle of older cancer patients than in age-matched healthy adults. Importantly, using immunoblot, we reveal that lower mass ERG1A protein is 61.5% ( < 0.05) more abundant in the skeletal muscle of cachectic older adults than in healthy age-matched controls. Additionally, we report that the ERG1A protein is detected in a cultured human rhabdomyosarcoma line that may be a good in vitro model for the study of ERG1A in muscle.

Conclusions: The data demonstrate that ERG1A is detected more abundantly in the atrophied skeletal muscle of cancer patients, suggesting it may be related to muscle loss in humans as it has been shown to be in mice experiencing muscle atrophy as a result of malignant tumors.
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http://dx.doi.org/10.3390/diagnostics11101879DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8534910PMC
October 2021

Could the Pittsburgh Severity Score guide the treatment of esophageal perforation? Experience of a single referral center.

J Trauma Acute Care Surg 2022 01;92(1):108-116

From the Clinica Chirurgica 3, Department of Surgical, Oncological and Gastroenterological Sciences, Università di Padova, Padova, Italy.

Background: Esophageal perforation (EP) is characterized by high morbidity and mortality. The Pittsburgh Severity Score (PSS) is a scoring system based on clinical factors at the time of EP presentation, intended to guide treatment. The aim of the study is to verify PSS usefulness in stratifying EP severity and in guiding clinical decisions.

Methods: All patients referred to our unit for EP between January 2005 and January 2020 were enrolled. Patients were stratified according to their PSS into three groups (PSS ≤ 2, 3-5, and >5): the postoperative outcomes were compared. The predictive value of the PSS was evaluated by simple linear and logistic regression for the following outcomes: need for surgery, complications, in-hospital mortality, intensive care unit (ICU) and hospital stay, time to refeeding, and need for reintervention.

Results: Seventy-three patients were referred for EP (male/female, 46/27). Perforations were more frequently iatrogenic (41.1%) or spontaneous (38.3%). The median PSS was 4 (interquartile range, 2-6). Surgery was required in 60.3% of cases. Pittsburgh Severity Score was associated with ICU admission, hospital stay, need for surgery and reintervention, postperforation complications and mortality. After regression analysis, PSS was significantly predictive of postperforation complications (p < 0.01), in-hospital mortality (p = 0.01), ICU admission (p < 0.01), need for surgical treatment (p < 0.01), and need for reintervention (p = 0.02).

Conclusion: Pittsburgh Severity Score is useful in stratifying patients in risk groups with different morbidity and mortality. It is also useful in guiding the therapeutic conduct, selecting patients for nonoperative management. Prospective studies are needed to confirm the role of the PSS in the treatment of esophageal perforation.

Level Of Evidence: Management, Therapeutic/Care; level IV.
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http://dx.doi.org/10.1097/TA.0000000000003417DOI Listing
January 2022

Perturbed BMP signaling and denervation promote muscle wasting in cancer cachexia.

Sci Transl Med 2021 08;13(605)

Baker Heart and Diabetes Institute, Melbourne, VIC 3004, Australia.

Most patients with advanced solid cancers exhibit features of cachexia, a debilitating syndrome characterized by progressive loss of skeletal muscle mass and strength. Because the underlying mechanisms of this multifactorial syndrome are incompletely defined, effective therapeutics have yet to be developed. Here, we show that diminished bone morphogenetic protein (BMP) signaling is observed early in the onset of skeletal muscle wasting associated with cancer cachexia in mouse models and in patients with cancer. Cancer-mediated factors including Activin A and IL-6 trigger the expression of the BMP inhibitor Noggin in muscle, which blocks the actions of BMPs on muscle fibers and motor nerves, subsequently causing disruption of the neuromuscular junction (NMJ), denervation, and muscle wasting. Increasing BMP signaling in the muscles of tumor-bearing mice by gene delivery or pharmacological means can prevent muscle wasting and preserve measures of NMJ function. The data identify perturbed BMP signaling and denervation of muscle fibers as important pathogenic mechanisms of muscle wasting associated with tumor growth. Collectively, these findings present interventions that promote BMP-mediated signaling as an attractive strategy to counteract the loss of functional musculature in patients with cancer.
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http://dx.doi.org/10.1126/scitranslmed.aay9592DOI Listing
August 2021

The Prognostic Value of Low Muscle Mass in Pancreatic Cancer Patients: A Systematic Review and Meta-Analysis.

J Clin Med 2021 Jul 7;10(14). Epub 2021 Jul 7.

Department of Surgery, Oncology and Gastroenterology, 3rd Surgical Clinic, University of Padua, Via Giustiniani 2, 35128 Padua, Italy.

Low muscle mass is associated with reduced survival in patients with different cancer types. The interest in preoperative sarcopenia and pancreatic cancer has risen in the last decade as muscle mass loss seems to be associated with poorer survival, higher postoperative morbidity, and mortality. The aim of the present study was to review the literature to compare the impact of low muscle mass on the outcomes of patients undergoing surgery for pancreatic adenocarcinoma. An extensive literature review was conducted according to the 2009 Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and 10 articles were analyzed in detail and included in the meta-analysis. Data were retrieved on 2811 patients undergoing surgery for pancreatic cancer. Meta-analysis identified that patients with low muscle mass demonstrated a significantly reduced OS when compared to patients without alterations of the muscle mass (ROM 0.86; 95% CI: 0.81-0.91, < 0.001), resulting in a 14% loss for the former. Meta-analysis failed to identify an increase in the postoperative complications and length of stay of patients with low muscle mass. Our analysis confirms the role of low muscle mass in influencing oncologic outcomes in pancreatic cancer. Its role on surgical outcomes remains to be established.
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http://dx.doi.org/10.3390/jcm10143033DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8306134PMC
July 2021

SARS-CoV-2 antibody dynamics and transmission from community-wide serological testing in the Italian municipality of Vo'.

Nat Commun 2021 07 19;12(1):4383. Epub 2021 Jul 19.

Department of Medicine, University of Padova, Padova, Italy.

In February and March 2020, two mass swab testing campaigns were conducted in Vo', Italy. In May 2020, we tested 86% of the Vo' population with three immuno-assays detecting antibodies against the spike and nucleocapsid antigens, a neutralisation assay and Polymerase Chain Reaction (PCR). Subjects testing positive to PCR in February/March or a serological assay in May were tested again in November. Here we report on the results of the analysis of the May and November surveys. We estimate a seroprevalence of 3.5% (95% Credible Interval (CrI): 2.8-4.3%) in May. In November, 98.8% (95% Confidence Interval (CI): 93.7-100.0%) of sera which tested positive in May still reacted against at least one antigen; 18.6% (95% CI: 11.0-28.5%) showed an increase of antibody or neutralisation reactivity from May. Analysis of the serostatus of the members of 1,118 households indicates a 26.0% (95% CrI: 17.2-36.9%) Susceptible-Infectious Transmission Probability. Contact tracing had limited impact on epidemic suppression.
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http://dx.doi.org/10.1038/s41467-021-24622-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8289856PMC
July 2021

Forensic Implications of Anatomical Education and Surgical Training With Cadavers.

Front Surg 2021 23;8:641581. Epub 2021 Jun 23.

Department of Neurosciences, Institute of Human Anatomy, University of Padova, Padova, Italy.

Anatomical education and surgical training with cadavers are usually considered an appropriate method of teaching, above all for all surgeons at various levels. Indeed, in such a way they put into practice and exercise a procedure before performing it live, reducing the learning curve in a safe environment and the risks for the patients. Really, up to now it is not clear if the nonuse of the cadavers for anatomical education and surgical training can have also forensic implications. A substantial literature research was used for this review, based on PubMed and Web of Science database. From this review, it is clear that the cadaveric training could be considered mandatory, both for surgeons and for medical students, leading to a series of questions with forensic implications. Indeed, there are many evidences that a cadaver lab can improve the learning curve of a surgeon, above all in the first part of the curve, in which frequent and severe complications are possible. Consequently, a medical responsibility for residents and surgeons which perform a procedure without adequate training could be advised, but also for hospital, that has to guarantee a sufficient training for its surgeons and other specialists through cadaver labs. Surely, this type of training could help to improve the practical skills of surgeons working in small hospitals, where some procedures are rare. Cadaver studies can permit a better evaluation of safety and efficacy of new surgical devices by surgeons, avoiding using patients as ≪guinea pigs≫. Indeed, a legal responsibility for a surgeon and other specialists could exist in the use of a new device without an apparent regulatory oversight. For a good medical practice, the surgeons should communicate to the patient the unsure procedural risks, making sure the patients' full understanding about the novelty of the procedure and that they have used this technique on few, if any, patients before. Cadaver training could represent a shortcut in the standard training process, increasing both the surgeon learning curve and patient confidence. Forensic clinical anatomy can supervise and support all these aspects of the formation and of the use of cadaver training.
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http://dx.doi.org/10.3389/fsurg.2021.641581DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8260677PMC
June 2021

Manometric pattern progression in esophageal achalasia in the era of high-resolution manometry.

Ann Transl Med 2021 May;9(10):906

Department of Surgery, Oncology and Gastroenterology, School of Medicine, University of Padova, Padova, Italy.

Esophageal manometry represents the gold standard technique for the diagnosis of esophageal achalasia because it can detect both the lack of lower esophageal sphincter (LES) relaxation and abnormal peristalsis. From the manometric standpoint, cases of achalasia can be segregated on the grounds of three clinically relevant patterns according to the Chicago Classification v3.0. It is currently unclear whether they represent distinct entities or are part of a disease continuum with the possibility of transition from a pattern to another one. The four cases described in the present report could provide further insights on this topic because the manometric pattern changed from type III to type II in all patients-without any invasive treatment. The cases described here support the hypothesis that the different manometric patterns of achalasia represent different stages in the evolution of the same disease, type III being the early stage, type II an intermediate stage, and type I probably the end stage of achalasia.
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http://dx.doi.org/10.21037/atm.2020.03.149DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8184468PMC
May 2021

Optimal Treatment of cT2N0 Esophageal Carcinoma: Is Upfront Surgery Really the Way?

Ann Surg Oncol 2021 Dec 17;28(13):8387-8397. Epub 2021 Jun 17.

Clinica Chirurgica 3, Department of Surgical, Oncological and Gastroenterological Sciences, Università di Padova, Padova, Italy.

Background: Staging is inaccurate for cT2N0 esophageal cancer, and patients often are clinically mis-staged. This study aimed to evaluate the outcome after upfront surgery or neoadjuvant therapy, considering the impact of clinical "mis-staging."

Methods: This study reviewed patients with squamous cell carcinoma (SCC) or adenocarcinoma (ADK) of the esophagus who underwent upfront surgery (S group) or neoadjuvant treatment (chemoradiotherapy [CRT] group) for cT2N0 cancer. Overall survival (OS), disease-free survival (DFS), morbidity, and mortality were evaluated. Correctly staged (cTNM = pTNM), understaged (cTNM < pTNM), and overstaged (cTNM > pTNM) patients in the S group and the CRT group were analyzed. Risk factors for unexpected lymph-node involvement were identified in the S group and for cancer-related death in the whole study cohort.

Results: The study enrolled 229 patients with cT2N0 esophageal cancer. The 5-year OS rate was 34.2% in the S group versus 55.7% in the CRT group (p = 0.0088). The DFS also was significantly higher (p = 0.01). The morbidity and mortality rates were similar. In the S group, the cTNM was correctly staged for 21.4% and understaged for 63.4% of the patients, with 48.7% of the patients showing unexpected nodal involvement. A tumor length of 3 cm or more was an independent predictor of nodal metastases in SCC (p = 0.03), as was lymphovascular invasion (LVI) in ADK (p < 0.01). Cancer-related mortality was independently associated with lymph-node metastases (p = 0.03) and treatment by upfront surgery (p = 0.01).

Conclusion: Given the high rate of understaged patients in this study (63.4%), the authors advocate for combining the induction therapy with surgery in cT2N0, achieving better survival with similar morbidity and mortality.
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http://dx.doi.org/10.1245/s10434-021-10194-9DOI Listing
December 2021

Laparoscopic Revisional Surgery After Failed Heller Myotomy for Esophageal Achalasia: Long-Term Outcome at a Single Tertiary Center.

J Gastrointest Surg 2021 09 7;25(9):2208-2217. Epub 2021 Jun 7.

Clinica Chirurgica 3, Department of Surgical, Oncological and Gastroenterological Sciences, Università di Padova, Via Giustiniani, 2, 35128, Padova, Italy.

Background: Laparoscopic Heller myotomy (HM) has gained acceptance as the gold standard of treatment for achalasia. However, 10-20% of the patients will experience symptom recurrence, thus requiring further treatment including pneumodilations (PD) or revisional surgery. The aim of our study was to assess the long-term outcome of laparoscopic redo HM.

Methods: Patients who underwent redo HM at our center between 2000 and 2019 were enrolled. Postoperative outcomes of redo HM patients (redo group) were compared with that of patients who underwent primary laparoscopic HM in the same time span (control group). For the control group, we randomly selected patients matched for age, sex, FU time, Eckardt score (ES), previous PD, and radiological stage. Failure was defined as an Eckardt score > 3 or the need for re-treatment.

Results: Forty-nine patients underwent laparoscopic redo HM after failed primary HM. A new myotomy on the right lateral wall of the EGJ was the procedure of choice in the majority of patients (83.7%). In 36 patients (73.5%) an anti-reflux procedure was deemed necessary. Postoperative outcomes were somewhat less satisfactory, albeit comparable to the control group; the incidence of postoperative GERD was higher in the redo group (p < 0.01). At a median 5-year FU time, a good outcome was obtained in 71.4% of patients in the redo group; further 5 patients (10.2%) obtained a long-term symptom control after complementary PD, thus bringing the overall success rate to 81.6%. Stage IV disease at presentation was independently associated with a poor outcome of revisional LHD (p = 0.003).

Conclusions: This study reports the largest case series of laparoscopic redo HM to date. The procedure, albeit difficult, is safe and effective in relieving symptoms in this group of patients with a highly refractory disease. The failure rate, albeit not significantly, and the post-operative reflux are higher than after primary HM. Patients with stage IV disease are at high risk of esophagectomy.
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http://dx.doi.org/10.1007/s11605-021-05041-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8484080PMC
September 2021

Laparoscopic Heller-Dor Is an Effective Treatment for Esophageal-Gastric Junction Outflow Obstruction.

J Gastrointest Surg 2021 09 6;25(9):2201-2207. Epub 2021 May 6.

Department of Surgical, Oncological and Gastroenterological Sciences, University of Padova, School of Medicine, Clinica Chirurgica 3, Azienda Ospedale Università di Padova, Padova, Italy.

Background: The treatment of esophagogastric junction outflow obstruction (EGJOO) currently mirrors that of achalasia, but this is based on only a few studies on small case series. The aim of this prospective, controlled study was to assess the outcome of laparoscopic Heller-Dor (LHD) in patients with EGJOO, as compared with patients with esophageal achalasia.

Materials And Methods: Between 2016 and 2019, patients with manometric diagnosis of idiopathic EGJOO and patients with radiological stage I achalasia, both treated with LHD, were compared. The achalasia group was further analyzed by subgrouping the patients based on the manometric pattern. Treatment failure was defined as the persistence or reoccurrence of an Eckardt score > 3 or the need for retreatment.

Results: During the study period, 150 patients were enrolled: 25 patients had EGJOO and 125 had radiological stage I achalasia (25 pattern I, 74 pattern II, and 26 pattern III). The median follow-up was 24 months (IQR: 34-16). Treatment was successful in 96% of patients in the EGJOO group and in 96% of achalasia patients with pattern I, 98.7% in those with pattern II, and 96.2% of those with pattern III (p=0.50). High-resolution manometry showed a reduction in the LES resting pressure and integrated relaxation pressure for all patients in all 4 groups (p<0.001).

Conclusion: This is the first comparative study based on prospective data collection to assess the outcome of LHD in patients with EGJOO. LHD emerged as an effective treatment for EGJOO, with an excellent success rate, comparable with the procedure's efficacy in treating early-stage achalasia.
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http://dx.doi.org/10.1007/s11605-021-05021-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8484249PMC
September 2021

Pharyngo-Esophageal Perforation Following Anterior Cervical Spine Surgery: A Single Center Experience and a Systematic Review of the Literature.

Global Spine J 2022 May 23;12(4):719-731. Epub 2021 Apr 23.

Department of Surgical, Oncological and Gastroenterological Sciences, University of Padova, Clinica Chirurgica 3°, Via Giustiniani 2, Padova, Italy.

Study Design: Case series and systematic review of the Literature.

Objectives: Pharyngo-esophageal perforation (PEP) is a rare, life-threatening complication of anterior cervical spine surgery (ACSS). Best management of these patients remains poorly defined. The aim of this study is to present our experience with this entity and to perform a systematic Literature review to better clarify the appropriate treatment of these patients.

Methods: Patients referred to our center for PEP following ACSS (January 2002-December 2018) were identified from our database. Moreover, an extensive review of the English Literature was conducted according to the 2009 PRISMA guidelines.

Results: Twelve patients were referred to our Institution for PEP following ACSS. Indications for ACSS were trauma (n = 10), vertebral metastases (n = 1) and disc herniation (n = 1). All patients underwent hardware placement at the time of ACSS. There were 6 early and 6 delayed PEP. Surgical treatment was performed in 11 patients with total or partial removal of spine fixation devices, autologous bone graft insertion or plate/cage replacement, anatomical suture of the fistula and suture line reinforcement with myoplasty. Complete resolution of PEP was observed in 6 patients. Five patients experienced PEP persistence, requiring further surgical management in 2 cases. At a median follow-up of 18.8 months, all patients exhibited permanent resolution of the perforation.

Conclusions: PEP following ACSS is a rare but dreadful complication. Partial or total removal of the fixation devices, direct suture of the esophageal defect and coverage with tissue flaps seems to be an effective surgical approach in these patients.
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http://dx.doi.org/10.1177/21925682211005737DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9109565PMC
May 2022

Does Pathological Stage and Nodal Involvement Influence Long Term Oncological Outcomes after CROSS Regimen for Adenocarcinoma of the Esophagogastric Junction? A Multicenter Retrospective Analysis.

Cancers (Basel) 2021 Feb 7;13(4). Epub 2021 Feb 7.

Department of Surgery, European Institute of Oncology IRCCS, 20141 Milan, Italy.

After the results reported by the "Chemoradiotherapy for esophageal Cancer Followed by Surgery Study" (CROSS) trial, neo-adjuvant chemoradiotherapy became the standard treatment for locally advanced cancers of esophagus and gastroesophageal junction (GEJ). Excellent results were reported for squamocellular carcinomas (SCCs). Since the advent of the CROSS regimen, the results of surgery for esophageal adenocarcinomas (EAC) have cast some doubts about its efficacy on overall survival (OS) even in the presence of local response. This study evaluated the relation between pathological (yp) stage after CROSS regimen followed by surgery for adenocarcinoma of cardia and overall (OS) and disease-free survival (DFS). Sites of relapse after surgery were also analyzed. Patients submitted to the CROSS regimen for locally advanced EAC of the cardia followed by transthoracic esophagectomy were analyzed. Actuarial OS and DFS were analyzed and stratified according to yp stage. The site of relapse, distal and local, was also analyzed. The study included 132 patients. The 50-month OS and DFS were 45% and 6.7%, respectively. No differences emerged analyzing OS according to yp stage. Time to relapse was significantly longer for yp Stage I and II, and for yp N0, compared with yp N+. Recurrence occurred in 48 cases (36.3%) with a 9 months median time to relapse. Local and distal relapse were 10 (7.5%) and 38 (28.7%) cases, respectively ( ≦ 0.001). Pathological stage after CROSS regimen does not relate to OS and DFS. Time to recurrence is significantly longer for yp Stages I and II and ypN0. Chemoradiotherapy in a neoadjuvant setting may influence the site of relapse, significantly reducing local recurrences.
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http://dx.doi.org/10.3390/cancers13040666DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7915215PMC
February 2021

Foodborne botulism presenting as small bowel obstruction: a case report.

BMC Infect Dis 2021 Jan 12;21(1):55. Epub 2021 Jan 12.

Department of Surgery, Oncology and Gastroenterology, 3rd Surgical Clinic, University of Padua, via Giustiniani 2, 35128, Padova, Italy.

Background: Small bowel obstruction is one of the leading reasons for accessing to the Emergency Department. Food poisoning from Clostridium botulinum has emerged as a very rare potential cause of small bowel obstruction. The relevance of this case report regards the subtle onset of pathognomonic neurological symptoms, which can delay diagnosis and subsequent life-saving treatment.

Case Presentation: A 24-year-old man came to our Emergency Department complaining of abdominal pain, fever and sporadic self-limiting episodes of diplopia, starting 4 days earlier. Clinical presentation and radiological imaging suggested a case of small bowel obstruction. Non-operative management was adopted, which was followed by worsening of neurological signs. On specifically questioning the patient, we discovered that his parents had experienced similar, but milder symptoms. The patient also recalled eating home-made preserves some days earlier. A clinical diagnosis of foodborne botulism was established and antitoxin was promptly administered with rapid clinical resolution.

Conclusions: Though very rare, botulism can mimic small bowel obstruction, and could be associated with a rapid clinical deterioration if misdiagnosed. An accurate family history, frequent clinical reassessments and involvement of different specialists can guide to identify this unexpected diagnosis.
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http://dx.doi.org/10.1186/s12879-020-05759-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7801865PMC
January 2021

Impact of COVID-19 outbreak on esophageal cancer surgery in Northern Italy: lessons learned from a multicentric snapshot.

Dis Esophagus 2021 Jun;34(6)

General, Esophageal and Gastric Surgery Unit, University Hospital of Verona, Verona, Italy.

Coronavirus Disease-19 (COVID-19) outbreak has significantly burdened healthcare systems worldwide, leading to reorganization of healthcare services and reallocation of resources. The Italian Society for Study of Esophageal Diseases (SISME) conducted a national survey to evaluate changes in esophageal cancer management in a region severely struck by COVID-19 pandemic. A web-based questionnaire (26 items) was sent to 12 SISME units. Short-term outcomes of esophageal resections performed during the lockdown were compared with those achieved in the same period of 2019. Six (50%) centers had significant restrictions in their activity. However, overall number of resections did not decrease compared to 2019, while a higher rate of open esophageal resections was observed (40 vs. 21.7%; P = 0.034). Surgery was delayed in 24 (36.9%) patients in 6 (50%) centers, mostly due to shortage of anesthesiologists, and occupation of intensive care unit beds from intubated COVID-19 patients. Indications for neoadjuvant chemo (radio) therapy were extended in 14% of patients. Separate COVID-19 hospital pathways were active in 11 (91.7%) units. COVID-19 screening protocols included nasopharyngeal swab in 91.7%, chest computed tomography scan in 8.3% and selective use of lung ultrasound in 75% of units. Postoperative interstitial pneumonia occurred in 1 (1.5%) patient. Recovery from COVID-19 pandemic was characterized by screening of patients in all units, and follow-up outpatient visits in only 33% of units. This survey shows that clinical strategies differed considerably among the 12 SISME centers. Evidence-based guidelines are needed to support the surgical esophageal community and to standardize clinical practice in case of further pandemics.
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http://dx.doi.org/10.1093/dote/doaa124DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7717178PMC
June 2021

Histology of the spleen in immune thrombocytopenia: clinical-pathological characterization and prognostic implications.

Eur J Haematol 2021 Feb 2;106(2):281-289. Epub 2020 Dec 2.

Surgical Pathology and Cytopathology Unit, Department of Medicine-DIMED, University of Padova, Padova, Italy.

Objective: Immune thrombocytopenia (ITP) is an acquired disorder, characterized by immune-mediated platelet destruction. The spleen plays a key pathogenic role in ITP and splenectomy is a valuable second-line therapy for this disease. Little is known on ITP spleen histology and response to splenectomy is unpredictable. This study aims to characterize ITP spleen histology and assess possible predictors of splenectomy outcome.

Methods: A series of 23 ITP spleens were retrospectively assessed for the following histological parameters: density of lymphoid follicles (LFs), marginal zones (MZs), T helper and cytotoxic T cells; presence of reactive germinal centers (GCs); width of perivascular T cell sheaths; and red pulp features. Clinical and histological data were matched with postsplenectomy platelet counts to assess their prognostic relevance.

Results: Three histological patterns were documented: a hyperplastic white pulp pattern, a non-activated white pulp pattern (lacking GCs), and a white pulp-depleted pattern. Poor surgical responses were associated with presplenectomy high-dose steroid administration, autoimmune comorbidities and low T follicular helper cell density. The combination of such parameters stratified patients into different splenectomy response groups. The removal of accessory spleens was also associated with better outcome.

Conclusion: ITP spleens are histologically heterogeneous and clinical-pathological parameters may help predict the splenectomy outcome.
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http://dx.doi.org/10.1111/ejh.13547DOI Listing
February 2021

Labelled micelles for the delivery of cytotoxic Cu(II) and Ru(III) compounds in the treatment of aggressive orphan cancers: Design and biological in vitro data.

J Inorg Biochem 2020 12 2;213:111259. Epub 2020 Oct 2.

Department of Chemical Sciences, University of Padova, Via F. Marzolo 1, 35131 Padova, Italy. Electronic address:

A recent study on our metal-dithiocarbamato complexes pointed out the antiproliferative properties and the druglikeness of some new patented derivatives. In this work, the best compounds have been encapsulated in micellar nanocarriers, being also carbohydrate-functionalized on their hydrophilic surface to investigate the possibility of a cancer-selective delivery. In particular, the nonionic block copolymer Pluronic® F127 (PF127) has been chemically modified with sugars and the derivatives characterized by means of NMR spectroscopy and FT-IR spectrophotometry. Then, the two selected complexes (β-[Ru(PipeDTC)]Cl (PipeDTC = piperidine dithiocarbamate) and [Cu(ProOMeDTC)] (ProOMeDTC = L-proline methyl ester dithiocarbamate)), have been loaded into the hydrophobic core of PF127 micelles and cancer-targeting counterparts. These nanoformulations have been studied for their dimensions (DLS, TEM) and stability, and tested for their cytotoxicity against aggressive human cancer cell lines. The in vitro results were paralleled with mechanistic studies through Confocal Laser Scanning Microscopy and xCELLigence analysis.
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http://dx.doi.org/10.1016/j.jinorgbio.2020.111259DOI Listing
December 2020

COVID-19 challenge: proactive management of a Tertiary University Hospital in Veneto Region, Italy.

Pathog Glob Health 2020 09 23;114(6):309-317. Epub 2020 Aug 23.

Department of Directional Hospital Management, Azienda Ospedale Università Padova , Padua, Italy.

Background: The aim of this study is to describe the successful emergency plan implemented by Padova University Hospital (AOUP) during the COVID-19 pandemic.

Methods: The emergency plan included early implementation of procedures aimed at meeting the increasing demand for testing and care while ensuring safe and timely care of all patients and guaranteeing the safety of healthcare workers.

Results: From 21 February to 1 May 2020, there were 3,862 confirmed cases of SARS-CoV-2 infection in the Province of Padua. A total of 485 patients were hospitalized in AOUP, of which 91 were admitted to the ICU; 12 .6% of admitted patients died. The average bed occupancy rate in the ICU was 61.1% (IQR 43.6%:77.4%). Inpatient surgery and inpatient admissions were kept for 76% and 74%, respectively, compared to March 2019. A total of 123,077 swabs were performed, 19.3% of which (23,725 swabs) to screen AOUP workers. The screening of all staff showed that 137 of 7,649 (1.8%) hospital workers were positive. No healthcare worker died.

Discussion: AOUP strategy demonstrated effective management of the epidemic thanks to the timely implementation of emergency procedures, a well-coordinated effort shared by all hospital Departments, and their continuous adjustment to the ongoing epidemic. Timely screening of all hospital workers proved to be particularly important to defend the hospital, avoiding epidemic clusters due to unknown positive cases.
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http://dx.doi.org/10.1080/20477724.2020.1806614DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7480614PMC
September 2020

Endoscopic diode laser therapy for gastric hyperplastic polyps in cirrhotic patients.

Lasers Med Sci 2021 Jul 19;36(5):975-979. Epub 2020 Aug 19.

Department of Surgery, Oncology and Gastroenterology, Third Surgical Unit, University of Padova, Padua, Italy.

Purpose Endoscopic polypectomy to remove gastric hyperplastic polyps in cirrhotic patients is associated to a high risk of postprocedural bleeding. The current study set out to examine the effect of diode laser therapy used to treat this type of polyps in cirrhotic patients. Methods This single-center study retrospectively examined the data of cirrhotic patients with macroscopic bleeding or anemia who underwent diode laser therapy (940 nm wave length, 30-W power setting in continuous mode) to remove histology-confirmed hyperplastic gastric polyps. Results A total of 222 polyps (mean diameter 10 ± 8 mm) were treated in 55 patients who were included in the study. No complications such as bleeding or perforations were reported. After a mean of 5 ± 4 sessions, 31 patients (56%) were completely healed. In 16 patients (29%), there was only a partial response (mean polyp reduction diameter of 64 ± 15%), while 8 (15%) patients did not respond to treatment. Statistically significant better results were noted in the patients who underwent ≥ 2 laser sessions. Hemoglobin levels and number of blood transfusions required were not statistically different after treatment. After a mean study period of 21 ± 17 months, polyp recurrences were noted in 11 patients (20%), but none of the polyps had degenerated. Conclusion Diode laser therapy was found to be a safe treatment for hyperplastic polyps in cirrhotic patients. Due to the presence of others bleeding lesions in cirrhotic patients, this treatment did not have an impact on anemia and transfusion requirements.
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http://dx.doi.org/10.1007/s10103-020-03127-7DOI Listing
July 2021

Esophageal perforation due to difficult intubation: our experience and review of literature.

Minerva Surg 2021 02 6;76(1):97-98. Epub 2020 Aug 6.

Unit of Endocrine Surgery, Department of Surgery, Istituto Oncologico Veneto (IOV), Padua, Italy.

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http://dx.doi.org/10.23736/S2724-5691.20.08422-9DOI Listing
February 2021

Suppression of a SARS-CoV-2 outbreak in the Italian municipality of Vo'.

Nature 2020 08 30;584(7821):425-429. Epub 2020 Jun 30.

School of Medicine, University of Padova, Padua, Italy.

On 21 February 2020, a resident of the municipality of Vo', a small town near Padua (Italy), died of pneumonia due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. This was the first coronavirus disease 19 (COVID-19)-related death detected in Italy since the detection of SARS-CoV-2 in the Chinese city of Wuhan, Hubei province. In response, the regional authorities imposed the lockdown of the whole municipality for 14 days. Here we collected information on the demography, clinical presentation, hospitalization, contact network and the presence of SARS-CoV-2 infection in nasopharyngeal swabs for 85.9% and 71.5% of the population of Vo' at two consecutive time points. From the first survey, which was conducted around the time the town lockdown started, we found a prevalence of infection of 2.6% (95% confidence interval (CI): 2.1-3.3%). From the second survey, which was conducted at the end of the lockdown, we found a prevalence of 1.2% (95% CI: 0.8-1.8%). Notably, 42.5% (95% CI: 31.5-54.6%) of the confirmed SARS-CoV-2 infections detected across the two surveys were asymptomatic (that is, did not have symptoms at the time of swab testing and did not develop symptoms afterwards). The mean serial interval was 7.2 days (95% CI: 5.9-9.6). We found no statistically significant difference in the viral load of symptomatic versus asymptomatic infections (P = 0.62 and 0.74 for E and RdRp genes, respectively, exact Wilcoxon-Mann-Whitney test). This study sheds light on the frequency of asymptomatic SARS-CoV-2 infection, their infectivity (as measured by the viral load) and provides insights into its transmission dynamics and the efficacy of the implemented control measures.
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http://dx.doi.org/10.1038/s41586-020-2488-1DOI Listing
August 2020

International guidelines and recommendations for surgery during Covid-19 pandemic: A Systematic Review.

Int J Surg 2020 Jul 23;79:180-188. Epub 2020 May 23.

Department of Surgical, Oncological and Gastroenterological Sciences, University of Padova, Clinica Chirurgica 3, Via Giustiniani 2, 35128, Padova, Italy.

Background: During the COVID-19 pandemic, surgical departments were forced to re-schedule their activity giving priority to urgent procedures and non-deferrable oncological cases. There is a lack of evidence-based literature providing clinical and organizational guidelines for the management of a general surgery department. Aim of our study was to review the available recommendations published by general Surgery Societies and Health Institutions and evaluate the underlying Literature.

Materials And Methods: A review of the English Literature was conducted according to the AMSTAR and to the 2009 Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines.

Results: After eligibility assessment, a total of 22 papers and statements were analyzed. Surgical societies have established criteria for triage and prioritization in order to identify procedures that can be postponed after the pandemic and those that should not. Prioritization among oncologic cases represents a difficult task: clinicians have to balance a possible delay in cancer diagnosis or treatment against the risk for a potential COVID-19 exposure. There is broad agreement among guidelines that indication to proceed with surgery should be discussed in virtual Tumor Boards taking into consideration alternative therapeutic approaches. Several guidelines deal with the role of laparoscopic surgery during the pandemic: a tailored approach is currently suggested, with a case-by-case evaluation provided that appropriate personal protective equipment is available in order to minimize the potential risk of transmission. Finally, there is a considerable agreement in the published Literature concerning the management of the personnel during the peri- and intraoperative phase and on the technical advices regarding the induction, operative and recover maneuvers in COVID-19 cases.

Conclusions: During COVID-19 pandemic, it is of paramount importance to face the emergency in the most effective and efficient manner, retrieving resources from non-essential settings and, at the same time, providing care to high priority non-COVID-19 related diseases.
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http://dx.doi.org/10.1016/j.ijsu.2020.05.061DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7245259PMC
July 2020

An evaluation of trans-anal rectoscopic-assisted minimally invasive surgery (ARAMIS): a new platform for transanal surgery.

Int J Colorectal Dis 2020 Sep 24;35(9):1681-1687. Epub 2020 May 24.

Department of Surgery, Oncology and Gastroenterology, Section of Surgery, University of Padova, Clinica Chirurgica 3^, Sesto Piano Policlinico, Via Giustiniani 2, 35128, Padova, Italy.

Purpose: The study aimed to evaluate the feasibility and safety of a new trans-anal rectoscopic-assisted minimally invasive surgery (ARAMIS) platform to treat rectal lesions.

Methods: ARAMIS was first compared with two transanal minimally invasive surgery platforms (SILS Port and GelPOINT Path) on human cadavers. Surgeons with different experience performed running sutures at different distances, at four quadrants, using the three platforms and gave a score to visibility, safety, and maneuverability. ARAMIS was then utilized on patients affected with rectal neoplasia who met the inclusion criteria. Patients and tumor characteristic and results were prospectively collected. The follow-up examinations included proctoscopy at 3, 6, and 12 months.

Results: According to surgeons' scores, ARAMIS improves visibility and safety with respect to other platforms for distances beyond 10 cm. The procedure, which lasted an average of 59 min, was successfully carried out in 14 patients. No intraoperative or postoperative complications were reported. The mean tumor size was 3 cm; they were located a mean of 11 cm from the anal verge. Complete removal of the lesion was possible in 13/14 patients. There was one case of adenoma recurrence at follow-up.

Conclusion: Study results showed that ARAMIS, which is equipped with an adjustable rectoscope, can be considered a safe, effective platform for transanal surgery. The rectoscope protects the rectum during the procedure, a particularly important consideration when proximal rectal lesions are being treated. Further clinical studies are warranted to confirm these encouraging results.
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http://dx.doi.org/10.1007/s00384-020-03641-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7415033PMC
September 2020

Primary mesenteric vein thrombosis: a case series.

J Surg Case Rep 2020 Mar 24;2020(3):rjaa016. Epub 2020 Mar 24.

Department of Surgical, Oncological and Gastrointestinal Sciences, University of Padova, Padova, Italy.

Mesenteric vein thrombosis (MVT) is a rare condition, often misdiagnosed due to its vague and misleading clinical presentation. It can cause intestinal infarction, peritonitis, and consequently necessitate bowel resection. CT scanning with intravenous contrast enhancement is the gold standard for its diagnosis. Radiologists have an important role in defining the extent of thrombosis and identifying any signs of intestinal infarction influencing the decision whether or not to operate. In patients with no clinical signs of peritonitis or radiological evidence of intestinal infarction, the treatment can be exclusively medical, based on full anticoagulation (initially with low molecular weight heparin, followed by vitamin K antagonists or direct acting oral-anticoagulants). The duration of medical treatment depends on radiological evidence of resolution of thrombosis and the identification of pro-coagulant risk factors.
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http://dx.doi.org/10.1093/jscr/rjaa016DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7092682PMC
March 2020

Poem Versus Laparoscopic Heller Myotomy in the Treatment of Esophageal Achalasia: A Case-Control Study from Two High Volume Centers Using the Propensity Score.

J Gastrointest Surg 2020 03 17;24(3):505-515. Epub 2019 Dec 17.

Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università Cattolica del Sacro Cuore, Center for Endoscopic Research, Therapeutics and Training (CERTT), Rome, 00168, Italy.

Background: POEM has recently had a widespread diffusion, aiming at being the treatment of choice for esophageal achalasia. The results of ongoing RCTs against laparoscopic myotomy are not available, yet. We, therefore, designed this propensity score (PS) case-control study with the aim of evaluating how POEM compares to the long-standing laparoscopic Heller myotomy + Dor fundoplication (LHD) and verifying if it may really replace the latter as the first-line treatment for achalasia.

Methods: Two groups of consecutive patients undergoing treatment for primary achalasia from January 2014 to November 2017 were recruited in two high-volume centers, one with extensive experience with POEM and one with LHD. Patients with previous endoscopic treatment were included, whereas patients with previous LHD or POEM were excluded. A total of 140 patients in both centers were thus matched. LHD and POEM were performed following established techniques. The patients were followed with clinical (Eckardt score), endoscopic, and pH-manometry evaluations.

Results: The procedure was successfully completed in all the patients. POEM required a shorter operation time and postoperative stay compared to LHD (p < 0.001). No mortality was recorded in either group. Seven complications were recorded in the POEM group (five mucosal perforations) and 3 in the LHD group (3 mucosal perforations)(p = 0.33). Two patients in the POEM group and one in the LHD were lost to follow-up. One patient in both groups died during the follow-up for unrelated causes. At a median follow-up of 24 months [15-30] for POEM and 31 months [15-41] for LHD (p < 0.05), 99.3% of the POEM patients and 97.7% of the LHD patients showed an Eckardt score ≤ 3 (p < 0.12). Four years after the treatment, the probability to have symptoms adequately controlled was > 90% for both groups (p = 0.2, Log-rank test). HR-Manometry showed a similar reduction in the LES pressure and 4sIRP; 24-h pH-monitoring showed however an abnormal exposure to acid in 38.4% of POEM patients, as compared to 17.1% of LHD patients (p < 0.01) and esophagitis was found in 37.4% of the POEM and 15.2% of LHD patients (p < 0.05).

Conclusion: POEM provides the same midterm results as LHD. This study confirms, however, a higher incidence of postoperative GERD with the former, even if its real significance needs to be further evaluated.
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http://dx.doi.org/10.1007/s11605-019-04465-wDOI Listing
March 2020

A Technical Modification to the Circular Stapling Anastomosis Technique During Minimally Invasive Ivor Lewis Procedure.

J Laparoendosc Adv Surg Tech A 2019 Dec 3;29(12):1585-1591. Epub 2019 Oct 3.

Department of Surgical, Oncological and Gastroenterological Sciences, University Hospital of Padova Center for Esophageal Diseases, University of Padova, Padova, Italy.

The circular stapled (CS) technique with transoral placement of the anvil is commonly used to perform the esophagogastric anastomosis during minimally invasive esophagectomy (MIE). The procedure is safe, efficient, and highly reproducible; however, the intersection between the circular plane of the stapler and the linear staple line of the esophageal stump can expose the anastomosis to the formation of dog-ears and, therefore, increase the risk of anastomotic leak (AL). We describe a simple modification of the CS technique that consists of folding the linear esophageal transection line with a stitch around the anvil shaft, to include the staple line in the resection during the EEA firing. We prospectively collected data on a small group of patients who underwent MIE for cancer using our modified CS technique. Feasibility has been evaluated as the percentage of cases in which the modified anastomosis technique has been carried out successfully with the formation of a complete anastomotic ring. Safety has been defined as the absence of procedure-related complications. MIE was performed in 10 patients using our modified CS technique. All the procedures were successfully completed with complete resection of the linear esophageal staple line and no intraoperative complications. Only one patient developed a postoperative AL that was only detected by barium swallow and did not cause any symptom or clinical sign. Our modified CS technique is feasible and did successfully prevent the occurrence of clinically relevant ALs in this small case series of patients.
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http://dx.doi.org/10.1089/lap.2019.0461DOI Listing
December 2019

Traction on the septum during transoral septotomy for Zenker diverticulum improves the final outcome.

Laryngoscope 2020 03 25;130(3):637-640. Epub 2019 Apr 25.

Department of Surgical, Oncological and Gastrointestinal Sciences, University of Padova, Clinica Chirurgica 3, Padova, Italy.

Objective: Transoral diverticulostomy/septotomy has become a popular treatment for patients with Zenker diverticulum (ZD). To improve the results of transoral stapler-assisted septotomy, a modification of the technique has been introduced. In this study, we aimed to compare the final outcome of such a modified transoral septotomy (MTS) with the results of traditional transoral septotomy (TTS) in patients with ZD.

Methods: Fifty-two consecutive patients with ZD underwent transoral stapler-assisted septotomy between 2010 and 2018. Symptoms were recorded and scored using a detailed questionnaire. Barium swallow, endoscopy, and manometry were performed before and after the procedure.

Results: Of the 52 patients forming the study population (male:female = 35:17), 25 had TTS and 27 had MTS. The patients' demographic and clinical parameters were similar in the two groups. No intraoperative mucosal lesions were detected, and the mortality was nil. The median time taken to complete the procedure was 25 minutes (interquartile range [IQR]: 22-35) for TTS, and 30 minutes (IQR: 25-36) for MTS (P < 0.07). The median follow-up was 69 months (IQR: 46-95) in the TTS group and 30 months (IQR: 25-35) in the MTS group. All patients in both groups had an improvement in their symptom score after the procedure, but the failure rates were 32% (8 of 25) after TTS and 3.7% (1 of 27) after MTS (P < 0.02). At univariate and multivariate analyses, the procedure was the only predictor of a positive final outcome.

Conclusion: Albeit with the intrinsic limitations of the study (retrospective, different time window, and different follow-up), traction on the septum during transoral septotomy improves the final outcome of this treatment in patients with ZD.

Level Of Evidence: 4 Laryngoscope, 130:637-640, 2020.
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http://dx.doi.org/10.1002/lary.28030DOI Listing
March 2020
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