Publications by authors named "Benoit Coffin"

82 Publications

Circulating bile acids concentration is predictive of coronary artery disease in human.

Sci Rep 2021 11 22;11(1):22661. Epub 2021 Nov 22.

Centre de Recherche Sur I'inflammation, Inserm, UMR 1149, Université de Paris, 75018, Paris, France.

Synthetized by the liver and metabolized by the gut microbiota, BA are involved in metabolic liver diseases that are associated with cardiovascular disorders. Animal models of atheroma documented a powerful anti-atherosclerotic effect of bile acids (BA). This prospective study examined whether variations in circulating BA are predictive of coronary artery disease (CAD) in human. Consecutive patients undergoing coronary angiography were enrolled. Circulating and fecal BA were measured by high pressure liquid chromatography and tandem mass spectrometry. Of 406 screened patients, 80 were prospectively included and divided in two groups with (n = 45) and without (n = 35) CAD. The mean serum concentration of total BA was twice lower in patients with, versus without CAD (P = 0.005). Adjusted for gender and age, this decrease was an independent predictor of CAD. In a subgroup of 17 patients, statin therapy doubled the serum BA concentration. Decreased serum concentrations of BA were predictors of CAD in humans. A subgroup analysis showed a possible correction by statins. With respect to the anti-atherosclerotic effect of BA in animal models, and their role in human lipid metabolism, this study describe a new metabolic disturbance associated to CAD in human.
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http://dx.doi.org/10.1038/s41598-021-02144-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8608912PMC
November 2021

Bariatric Surgery in Patients With Inflammatory Bowel Disease: A Case-Control Study from the GETAID.

Inflamm Bowel Dis 2021 Oct 12. Epub 2021 Oct 12.

AP-HP, Hôpital Louis Mourier, DMU ESPRIT, Service de Gastroentérologie, Université de Paris, Colombes, France.

Background: The prevalence of obesity and the number of bariatric surgeries in both the general population and in patients with inflammatory bowel disease (IBD) have increased significantly in recent years. Due to small sample sizes and the lack of adequate controls, no definite conclusions can be drawn from the available studies on the safety and efficacy of bariatric surgery (BS) in patients with IBD. Our aim was to assess safety, weight loss, and deficiencies in patients with IBD and obesity who underwent BS and compare findings to a control group.

Methods: Patients with IBD and a history of BS were retrospectively recruited to centers belonging to the Groupe d'Etude Thérapeutique des Affections Inflammatoires du Tube Digestif (GETAID). Patients were matched 1:2 for age, sex, body mass index (BMI), hospital of surgery, and type of BS with non-IBD patients who underwent BS. Complications, rehospitalizations, weight, and deficiencies after BS were collected in cases and controls.

Results: We included 88 procedures in 85 patients (64 Crohn's disease, 20 ulcerative colitis, 1 unclassified IBD) with a mean BMI of 41.6 ± 5.9 kg/m2. Bariatric surgery included Roux-en-Y gastric bypass (n = 3), sleeve gastrectomy (n = 73), and gastric banding (n = 12). Eight (9%) complications were reported, including 4 (5%) requiring surgery. At a mean follow-up of 34 months, mean weight was 88.6 ± 22.4 kg. No difference was observed between cases and controls for postoperative complications (P = .31), proportion of weight loss (P = .27), or postoperative deficiencies (P = .99).

Conclusions: Bariatric surgery is a safe and effective procedure in patients with IBD and obesity; outcomes in this patient group were similar to those observed in a control population.
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http://dx.doi.org/10.1093/ibd/izab249DOI Listing
October 2021

Maintenance of a Gastric Pacemaker in the Excluded Stomach During a Roux-en-Y Gastric Bypass Procedure in a Patient with Obesity, Type 1 Diabetes and Refractory Gastroparesis.

Obes Surg 2021 Dec 6;31(12):5497-5499. Epub 2021 Oct 6.

Centre Hospitalier Universitaire Ambroise Paré, Service d'Endocrinologie Diabétologie et Nutrition, Assistance Publique-Hôpitaux de Paris, 9 avenue Charles De Gaulle, 92100, Boulogne Billancourt, France.

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http://dx.doi.org/10.1007/s11695-021-05726-xDOI Listing
December 2021

United European Gastroenterology (UEG) and European Society for Neurogastroenterology and Motility (ESNM) consensus on functional dyspepsia.

Neurogastroenterol Motil 2021 09;33(9):e14238

Gastroenterology Unit, Departmento of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy.

Background: Functional dyspepsia (FD) is one of the most common conditions in clinical practice. In spite of its prevalence, FD is associated with major uncertainties in terms of its definition, underlying pathophysiology, diagnosis, treatment, and prognosis.

Methods: A Delphi consensus was initiated with 41 experts from 22 European countries who conducted a literature summary and voting process on 87 statements. Quality of evidence was evaluated using the grading of recommendations, assessment, development, and evaluation (GRADE) criteria. Consensus (defined as >80% agreement) was reached for 36 statements.

Results: The panel agreed with the definition in terms of its cardinal symptoms (early satiation, postprandial fullness, epigastric pain, and epigastric burning), its subdivision into epigastric pain syndrome and postprandial distress syndrome, and the presence of accessory symptoms (upper abdominal bloating, nausea, belching), and overlapping conditions. Also, well accepted are the female predominance of FD, its impact on quality of life and health costs, and acute gastrointestinal infections, and anxiety as risk factors. In terms of pathophysiological mechanisms, the consensus supports a role for impaired gastric accommodation, delayed gastric emptying, hypersensitivity to gastric distention, Helicobacter pylori infection, and altered central processing of signals from the gastroduodenal region. There is consensus that endoscopy is mandatory for establishing a firm diagnosis of FD, but that in primary care, patients without alarm symptoms or risk factors can be managed without endoscopy. There is consensus that H. pylori status should be determined in every patient with dyspeptic symptoms and H. pylori positive patients should receive eradication therapy. Also, proton pump inhibitor therapy is considered an effective therapy for FD, but no other treatment approach reached a consensus. The long-term prognosis and life expectancy are favorable.

Conclusions And Inferences: A multinational group of European experts summarized the current state of consensus on the definition, diagnosis and management of FD.
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http://dx.doi.org/10.1111/nmo.14238DOI Listing
September 2021

Gastroparesis in Parkinson Disease: Pathophysiology, and Clinical Management.

Brain Sci 2021 Jun 23;11(7). Epub 2021 Jun 23.

Centre Hospitalo-Universitaire de Rouen, INSERM UMR 1073, CIC-CRB 1404, 76000 Rouen, France.

Patients with Parkinson disease (PD) experience a range of non-motor symptoms, including gastrointestinal symptoms. These symptoms can be present in the prodromal phase of the disease. Recent advances in pathophysiology reveal that α-synuclein aggregates that form Lewy bodies and neurites, the hallmark of PD, are present in the enteric nervous system and may precede motor symptoms. Gastroparesis is one of the gastrointestinal involvements of PD and is characterized by delayed gastric emptying of solid food in the absence of mechanical obstruction. Gastroparesis has been reported in nearly 45% of PD. The cardinal symptoms include early satiety, postprandial fullness, nausea, and vomiting. The diagnosis requires an appropriate test to confirm delayed gastric emptying, such as gastric scintigraphy, or breath test. Gastroparesis can lead to malnutrition and impairment of quality of life. Moreover, it might interfere with the absorption of antiparkinsonian drugs. The treatment includes dietary modifications, and pharmacologic agents both to accelerate gastric emptying and relieve symptoms. Alternative treatments have been recently developed in the management of gastroparesis, and their use in patients with PD will be reported in this review.
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http://dx.doi.org/10.3390/brainsci11070831DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8301889PMC
June 2021

The Intestinal Gas Questionnaire (IGQ): Psychometric validation of a new instrument for measuring gas-related symptoms and their impact on daily life among general population and irritable bowel syndrome.

Neurogastroenterol Motil 2021 Jun 18:e14202. Epub 2021 Jun 18.

Patient-Centered Reported Outcomes, Paris-Diderot University, Paris, France.

Background: Gas-related symptoms (GRS) are common in the general population (GPop) and among patients with disorders of gut-brain interactions but there is no patient-reported outcome evaluating these symptoms and their impact on daily life. We have previously developed a 43-item intestinal gas questionnaire (IGQ). The aim of the present study is to perform a psychometric validation of this instrument.

Methods: Participants (119 from the GPop and 186 irritable bowel syndrome (IBS) patients) were recruited from 3 countries (UK, Spain, France). IBS patients fulfilled ROME IV criteria with an IBS severity score between 150 and 300. Participants completed the IGQ, the functional Digestive Disorders Quality of Life (FDDQL), and the EQ-5D. A subgroup (n = 90) repeated the IGQ completion after 7 days on paper or electronically.

Results: From the original IGQ questionnaire, 26 items were deleted because of poor performance. Confirmatory factorial analysis on the remaining 17 items (7 symptom and 10 impact items) yielded a 6-factor structure accounting for 67% of the variance for bloating (6 items), flatulence (3), belching (2), bad breath (2), stomach rumbling (2), and difficult gas evacuation (2). Global score (0-100) was worse among IBS vs GPop (40 ± 15 vs 33 ± 17; p = 0.0016). At the second visit, the intraclass correlation coefficient of IGQ scores was between 0.71 and 0.86 (n = 67) for test-retest reliability and 0.61-0.87 (n = 64) for equivalence between electronic and paper versions of IGQ.

Conclusion: The IGQ available in paper and electronic versions in 3 languages is a robust instrument for capturing and measuring GRS and their impact on daily life.
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http://dx.doi.org/10.1111/nmo.14202DOI Listing
June 2021

United European Gastroenterology (UEG) and European Society for Neurogastroenterology and Motility (ESNM) consensus on functional dyspepsia.

United European Gastroenterol J 2021 04;9(3):307-331

Gastroenterology Unit, Departmento of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy.

Background: Functional dyspepsia (FD) is one of the most common conditions in clinical practice. In spite of its prevalence, FD is associated with major uncertainties in terms of its definition, underlying pathophysiology, diagnosis, treatment, and prognosis.

Methods: A Delphi consensus was initiated with 41 experts from 22 European countries who conducted a literature summary and voting process on 87 statements. Quality of evidence was evaluated using the grading of recommendations, assessment, development, and evaluation (GRADE) criteria. Consensus (defined as >80% agreement) was reached for 36 statements.

Results: The panel agreed with the definition in terms of its cardinal symptoms (early satiation, postprandial fullness, epigastric pain, and epigastric burning), its subdivision into epigastric pain syndrome and postprandial distress syndrome, and the presence of accessory symptoms (upper abdominal bloating, nausea, belching), and overlapping conditions. Also, well accepted are the female predominance of FD, its impact on quality of life and health costs, and acute gastrointestinal infections, and anxiety as risk factors. In terms of pathophysiological mechanisms, the consensus supports a role for impaired gastric accommodation, delayed gastric emptying, hypersensitivity to gastric distention, Helicobacter pylori infection, and altered central processing of signals from the gastroduodenal region. There is consensus that endoscopy is mandatory for establishing a firm diagnosis of FD, but that in primary care, patients without alarm symptoms or risk factors can be managed without endoscopy. There is consensus that H. pylori status should be determined in every patient with dyspeptic symptoms and H. pylori positive patients should receive eradication therapy. Also, proton pump inhibitor therapy is considered an effective therapy for FD, but no other treatment approach reached a consensus. The long-term prognosis and life expectancy are favorable.

Conclusions And Inferences: A multinational group of European experts summarized the current state of consensus on the definition, diagnosis and management of FD.
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http://dx.doi.org/10.1002/ueg2.12061DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8259261PMC
April 2021

Do Preoperative Esophageal pH Monitoring and High-Resolution Manometry Predict Symptoms of GERD After Sleeve Gastrectomy?

Obes Surg 2021 08 20;31(8):3490-3497. Epub 2021 Apr 20.

Centre de Recherche sur l'Inflammation, Inserm UMRS 1149, Université de Paris, 75018, Paris, France.

Background: Predictive factors of evolution or appearance of gastroesophageal reflux disease (GERD) after sleeve gastrectomy (SG) have not been identified to date. We aimed to assess the evolution of GERD symptoms 1 year after SG and to determine preoperative predictive factors using high-resolution manometry (HRM) and ambulatory 24-h esophageal pH monitoring (APM).

Methods: We included 160 patients who underwent SG between 2013 and 2017 and performed preoperative APM and HRM. Positive APM was defined according to the Lyon consensus. Symptoms of GERD, proton pump inhibitors (PPI) use, weight loss (WL), and diet were recorded in all patients before and 1 year after surgery.

Results: One year after surgery, 58 patients (36.3%) complained of GERD symptoms compared to 52 patients (32.5%) preoperatively (p=0.48). Among patients with preoperative GERD symptoms, only 26/52 patients (50%) still had symptoms, whereas 32/108 (29.6%) asymptomatic patients developed de novo GERD symptoms after surgery. PPI use increased after surgery reaching 36.9% of patients against 15.0% before (p<0.0001). Only preoperative symptoms of GERD were predictive of postoperative symptoms (OR= 2.47 [1.14-5.45]; p=0.023) in multivariate analysis. Preoperative manometric parameters, postoperative diet, and WL were not related to postoperative symptoms. In asymptomatic patients before surgery, silent GERD (positive APM without symptom) was predictive of postoperative GERD symptoms (OR=2.69 [1.00-7.25]; p=0.049).

Conclusion: Evolution of GERD symptoms after SG reveals improvement for half of the patients and de novo GERD symptoms in one-third of patients. Predictive factors of postoperative symptoms are preoperative symptoms and positive preoperative APM in asymptomatic patients.
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http://dx.doi.org/10.1007/s11695-021-05427-5DOI Listing
August 2021

A Sengstaken-Blakemore tube to rescue respiratory failure due to oesophageal-pulmonary fistula.

Intensive Care Med 2021 06 9;47(6):702-703. Epub 2021 Mar 9.

AP-HP, Hôpital Louis Mourier, Médecine intensive Réanimation, 92700, Colombes, France.

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http://dx.doi.org/10.1007/s00134-021-06376-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7942525PMC
June 2021

Are bedside colonoscopies performed in intensive care unit really useful?

J Crit Care 2021 06 10;63:56-61. Epub 2021 Feb 10.

Université de Paris, CRI Inserm UMRS 1149, IAME Inserm UMR 1137, PHERE UMRS 1152, F-75018 Paris, France; APHP, Hôpital Bichat, Service de Pneumologie B et Transplantation Pulmonaire, F-75018 Paris, France. Electronic address:

Purpose: Effectiveness of bedside Colonoscopies in Intensive Care Unit (CICU) might be limited by the poor quality of colonic preparation, and their feasibility. We sought to describe the indications and the profitability of CICU.

Methods: Retrospective, bicenter observational study (2004-2015) in unselected critically ill patients. We questioned the clinical profitability of CICU, according to its indications and preparation.

Results: One hundred and eleven CICU were performed in 84 patients (sex ratio 1.4, 49 M/35F; age 72.9 years [61.7-84.7]), for lower gastro-intestinal bleeding in 67 patients (LGIB, 60.3%) and for other causes in 44 (39.6%). The profitability was more frequent when CICU was performed for another reason than LGIB (75% vs 28.3%; p < 0.0001). Preparation was good in 47 procedures (42.3%) and allowed 33 complete CICU (29.7%). Fifty-six CICU (50.4%) were performed as a 2nd investigation after a contrast enhanced computed tomography. Three CICU were complicated by 3 hemodynamic and 2 respiratory failures, but none of them were fatal.

Conclusions: CICU is clinically useful in half of cases, in the diagnostic and the therapeutic management of critically ill patients. Its profitability is close to scheduled colonoscopies and superior in non-lower gastro-intestinal bleeding indications.
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http://dx.doi.org/10.1016/j.jcrc.2021.02.001DOI Listing
June 2021

Intrahepatic cholestasis of pregnancy associated with azathioprine: A case series.

J Gynecol Obstet Hum Reprod 2021 Apr 15;50(4):102083. Epub 2021 Feb 15.

Fetal Medicine Department, Armand-Trousseau Hospital, Paris, France. Electronic address:

Background: Intrahepatic cholestasis of pregnancy (ICP) is characterised by otherwise unexplained maternal pruritus, increased serum bile acid concentration over 10 μmol/L and spontaneous relief of symptoms and liver abnormalities after delivery. It occurs most frequently during the third trimester and is usually not induced by medication. Besides, azathioprine is recommended as first-line immunosuppressant in patients with steroid-dependent inflammatory bowel disease and is allowed during pregnancy, in order to stabilize maternal disease.

Methods: We reviewed all cases of ICP between 2010 and 2018 in two French perinatal centers.

Results: We encountered eight pregnancies complicated by atypical ICP among patients treated with azathioprine. ICP associated with azathioprine appears to be biologically more severe and to occur earlier than "standard" ICP. Furthermore, clinical and biochemical abnormalities related to ICP disappear when azathioprine is discontinued. Azathioprine safety should be reconsidered and practitioners advised to discuss discontinuing this drug as soon as ICP diagnosis is established.
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http://dx.doi.org/10.1016/j.jogoh.2021.102083DOI Listing
April 2021

Impact of Gastric Electrical Stimulation on Economic Burden of Refractory Vomiting: A French Nationwide Multicentre Study.

Clin Gastroenterol Hepatol 2020 Nov 13. Epub 2020 Nov 13.

Nancy University Hospital, Nancy, France.

Background & Aims: Medico-economic data of patients suffering from chronic nausea and vomiting are lacking. In these patients, gastric electrical stimulation (GES) is an effective, but costly treatment. The aim of this study was to assess the efficacy, safety and medico-economic impact of Enterra therapy in patients with chronic medically refractory nausea and vomiting.

Methods: Data were collected prospectively from patients with medically refractory nausea and/or vomiting, implanted with an Enterra device and followed for two years. Gastrointestinal quality of life index (GIQLI) score, vomiting frequency, nutritional status and safety were evaluated. Direct and indirect expenditure data were prospectively collected in diaries.

Results: Complete clinical data were available for142 patients (60 diabetic, 82 non-diabetic) and medico-economic data were available for 96 patients (36 diabetic, 60 non-diabetic), 24 months after implantation. GIQLI score increased by 12.1 ± 25.0 points (p < .001), with a more significant improvement in non-diabetic than in diabetic patients (+15.8 ± 25.0 points, p < .001 versus 7.3 ± 24.5 points, p = .027, respectively). The proportion of patients vomiting less than once per month increased by 25.5% (p < .001). Hospitalisations, time off work and transport were the main sources of costs. Enterra therapy decreased mean overall healthcare costs from 8873 US$ to 5525 US$ /patient/year (p = .001), representing a saving of 3348 US$ per patient and per year. Savings were greater for diabetic patients (4096 US$ /patient/year) than for non-diabetic patients (2900 US$ /patient/year).

Conclusions: Enterra therapy is an effective, safe and cost-effective option for patients with refractory nausea and vomiting. ClinicalTrials.gov Identifier: NCT00903799.
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http://dx.doi.org/10.1016/j.cgh.2020.11.011DOI Listing
November 2020

Long-term outcome of Crohn's disease patients with upper gastrointestinal stricture: A GETAID study.

Dig Liver Dis 2020 11 20;52(11):1323-1330. Epub 2020 Sep 20.

Department of Gastroenterology, Claude Huriez hospital, University of Lille, Lille, France; Inserm Unit 995, University of Lille 2, Lille, France. Electronic address:

Background: There are few data concerning patients with Crohn's disease (CD) complicated by a stricture of the upper gastrointestinal tract (UGT).

Aims: We evaluated the outcome and management of CD patients complicated by a stricture of the UGT.

Methods: We performed a retrospective multicenter study including all CD patients with a non-passable symptomatic UGT stricture on endoscopy. Primary outcome measure was surgery-free survival from diagnosis of stricture. Efficacy of medical, endoscopic, and surgical treatments, and identification of predictors of surgery were also evaluated.

Results: 60 CD patients with an UGT stricture were included. 60% of the strictures were located in the duodenum. With a median follow-up of 5.5 (IQR: 3.0-12.0) years since stricture diagnosis, surgical-free survival was 75% and 64% at 1 and 5 years, respectively. At the end of the follow up, 27 (45%) patients underwent surgery. 77 endoscopic procedures were performed in 30 patients with an immediate success of 81% and a clinical benefit in 84% of the procedures. In multivariate analysis, anti-TNF treatment initiation was associated with a reduced risk of surgery.

Conclusion: CD UGT strictures are mainly located in the duodenum. Medical and endoscopic treatments allow to avoid surgery in half of the patients.
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http://dx.doi.org/10.1016/j.dld.2020.08.034DOI Listing
November 2020

Evolution of Endoscopic Lesions in Steroid-Refractory Acute Severe Ulcerative Colitis Responding to Infliximab or Cyclosporine.

Clin Gastroenterol Hepatol 2021 06 7;19(6):1180-1188.e4. Epub 2020 Aug 7.

INSERM UMR-S-1153, Equipe ECSTRA, Hôpital Saint-Louis, Paris Diderot University, Paris, France.

Background/aims: Few data on the evolution of endoscopic findings are available in patients with acute severe ulcerative colitis (ASUC). The aim of this study was to describe this evolution in a prospective cohort.

Methods: Patients admitted for a steroid-refractory ASUC and included in a randomized trial comparing infliximab and cyclosporine were eligible if they achieved steroid-free clinical remission at day 98. Flexible sigmoidoscopies were performed at baseline, days 7, 42 and 98. Ulcerative colitis endoscopic index of severity (UCEIS) and its sub-scores - vascular pattern, bleeding and ulceration/erosion - were post-hoc calculated. Global endoscopic remission was defined by a UCEIS of 0, and partial endoscopic remission by any UCEIS sub-score of 0.

Results: Among the 55 patients analyzed (29 infliximab and 26 cyclosporine), 49 (83%) had UCEIS ≥6 at baseline at baseline. Partial endoscopic remission rates were higher for bleeding than for vascular pattern and for ulcerations/erosions at day 7 (20% vs. 4% and 5% (n = 55); p = .004 and p=.04), for bleeding and ulceration/erosion than for vascular pattern at day 42 [63% and 65% vs. 33% (n=54); p<.001 for both] and at day 98 [78% and 92% vs. 56% (n = 50); p = .007 and p < .001]. Global endoscopic remission rates at day 98 were higher in patients treated with infliximab than with cyclosporine [73% vs. 25% (n = 26 and 24); p < .001].

Conclusion: In steroid-refractory ASUC patients responding to a second-line medical therapy, endoscopic remission process started with bleeding remission and was not achieved in half the patients at day 98 for vascular pattern. Infliximab provided a higher endoscopic remission rate than cyclosporine at day 98.
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http://dx.doi.org/10.1016/j.cgh.2020.08.001DOI Listing
June 2021

Randomised clinical trial: oesophageal radiofrequency energy delivery versus sham for PPI-refractory heartburn.

Aliment Pharmacol Ther 2020 08 13;52(4):637-645. Epub 2020 Jul 13.

Gastroenterology Department, CHU de Nantes, Institut des Maladies de l'Appareil Digestif (IMAD), CIC1413, Université de Nantes, Nantes, France.

Background: Oesophageal radiofrequency reduces use of proton pump inhibitors (PPIs) in patients with gastro-oesophageal reflux disease responding to PPIs.

Aim: To determine the efficacy of oesophageal radiofrequency in patients with PPI-refractory heartburn.

Methods: A randomised, double-blind, sham-controlled multicentre study was designed to assess the efficacy of oesophageal radiofrequency in PPI non-responding patients with heartburn. Patients had moderate-to-severe heartburn defined by at least 3 occurrences a week, and not improved by continuous PPI treatment. The primary endpoint was clinical success at week 24, defined by intake of less than 7 PPI doses over the 2 preceding weeks and adequate symptom control determined by the patient.

Results: Sixty two patients were randomised, 29 to the oesophageal radiofrequency group and 33 to the sham group. Intention-to-treat analysis showed that 1/29 (3.4%) and 5/33 (15.1%) achieved the primary endpoint in the oesophageal radiofrequency and sham groups, respectively (NS). There was no significant difference between oesophageal radiofrequency and sham regarding the number of days without heartburn, days with PPI consumption in the last 2 weeks, and patients not taking PPIs. No pH-impedance parameter was associated with clinical response. The occurrence of adverse events was similar in both groups.

Conclusion: This sham-controlled, randomised study did not demonstrate any efficacy of oesophageal radiofrequency for the treatment of PPI-refractory heartburn regarding symptom relief or consumption of PPIs. ClinicalTrials.gov NCT01682265.
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http://dx.doi.org/10.1111/apt.15936DOI Listing
August 2020

Jackhammer esophagus: Clinical presentation, manometric diagnosis, and therapeutic results-Results from a multicenter French cohort.

Neurogastroenterol Motil 2020 11 8;32(11):e13918. Epub 2020 Jun 8.

Gastroenterology Unit, AP-HP Hôpital Louis Mourier, Université de Paris, Paris, France.

Background/aims: Jackhammer esophagus (JE) is a hypercontractile esophageal motor disorder defined by at least two swallows with a distal contractile integral (DCI) >8000 mm Hg.s.cm during high-resolution manometry (HRM). The relationship between symptoms and hypercontractility and the response to therapies have been poorly evaluated. The aim of this study was to determine the clinical presentation, manometric diagnosis, and therapeutic results in a large cohort of JE patients.

Methods: Patients with JE diagnosed among the HRM tests performed in nine academic French centers from 01/01/2010 to 08/31/2016 were included. Patient charts were reviewed to collect clinical and therapeutic data.

Results: Among the 16 264 HRM tests performed during this period, 227 patients (60.8 ± 13.8 years, 151 male) had JE (1.7%). Dysphagia was the most frequent symptom (74.6%), followed by regurgitation (37.1%) and chest pain (36.6%); 4.7% of the patients were asymptomatic. The diagnostic workup was heterogeneous, and only a minority of patients had esophageal biopsies. None of the individual symptoms were significantly associated with any of the manometric parameters defined, except for dysphagia, which was significantly associated with the mean of all DCIs >8000 mm Hg.s.cm (P = .04). Additionally, the number of symptoms was not associated with any manometric parameter. Medical treatment and endoscopic treatments had poor efficacy and a high relapse rate.

Conclusion: Jackhammer esophagus is a rare motility disorder. Diagnostic workup is heterogeneous and should be standardized. Symptoms are poorly associated with manometric parameters. The medical treatments and endoscopic therapies currently used are inefficient.
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http://dx.doi.org/10.1111/nmo.13918DOI Listing
November 2020

Disruption of Circadian Rhythms and Gut Motility: An Overview of Underlying Mechanisms and Associated Pathologies.

J Clin Gastroenterol 2020 May/Jun;54(5):405-414

CHU de Rennes, Ille-et-Vilaine, Rennes, France.

Circadian rhythms ensure that physiological processes occur at the most biologically meaningful time. The circadian timing in the gastrointestinal tract involves interlocking transcriptional and translational feedback loops that culminate in the rhythmic expression and activity of a set of clock genes and related hormones. The suprachiasmatic nucleus and peripheral core molecular clocks oscillate every 24 hours and are responsible for the periodic activity of various segments and transit along the gastrointestinal tract. Environmental cues may alter or reset these rhythms to align them with new circumstances. Colonic motility also follows a circadian rhythm with reduced nocturnal activity. Healthy humans have normal bowel motility during the day, frequently following awakening or following a meal, with minimal activity during the night. Maladjusted circadian rhythms in the bowel have been linked to digestive pathologies, including constipation and irritable bowel syndrome. Our advanced knowledge of the link between the circadian clock and gastrointestinal physiology provides potential therapeutic approaches for the treatment of gastrointestinal diseases. This review seeks to establish evidence for the correlation between circadian rhythm, bowel movements and digestive health, and examine the implications of disrupted circadian rhythms on gut physiology.
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http://dx.doi.org/10.1097/MCG.0000000000001333DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7147411PMC
June 2021

The Role of Diet in Functional Dyspepsia Management.

Front Psychiatry 2020 5;11:23. Epub 2020 Feb 5.

Université de Paris, Paris, France.

Functional dyspepsia is a common functional gastrointestinal disease that is characterized by postprandial fullness, early satiation, epigastric pain, and/or epigastric burning. Eating a meal is a key factor in the occurrence of symptoms during functional dyspepsia, and patients frequently request dietary advice that could relieve these symptoms. Eating behaviors, irregular meal patterns, and moderate-to-fast eating rates are significantly associated with functional dyspepsia. The role of diet is complex; fat ingestion increases the occurrence of symptoms in dyspeptic patients, which might be affected by cognitive factors and palatability. Data concerning the role of carbohydrates are conflicting. Wheat may induce symptoms in patients with nonceliac gluten/wheat sensitivity, and gluten-free diets might be beneficial. Data concerning the role of FODMAPs (Fructo, Oligo, Di-, Monosaccharides, And Polyols) in functional dyspepsia are lacking; however, as there is a frequent overlap between functional dyspepsia and irritable bowel syndrome, a diet that is low in FODMAPs might be useful in relieving some symptoms. Data concerning alcohol are also conflicting. Adherence to a Mediterranean diet seems to be associated with a decrease in dyspepsia symptoms. Finally, data concerning diet modifications are conflicting, and the impact of diet modifications on symptom intensity or frequency has never been reported in randomized prospective studies. Common sense dietary recommendations, such as eating slowly and regularly, as well as decreasing the fat content of meals, can be provided in daily clinical practice.
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http://dx.doi.org/10.3389/fpsyt.2020.00023DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7012988PMC
February 2020

Gastric Electrical Stimulation Reduces Refractory Vomiting in a Randomized Crossover Trial.

Gastroenterology 2020 02 21;158(3):506-514.e2. Epub 2019 Oct 21.

Nancy University Hospital, Nancy, France.

Background & Aims: There have been conflicting results from trials of gastric electrical stimulation (GES) for treatment of refractory vomiting, associated or not with gastroparesis. We performed a large, multicenter, randomized, double-blind trial with crossover to study the efficacy of GES in patients with refractory vomiting, with or without gastroparesis.

Methods: For 4 months, we assessed symptoms in 172 patients (66% women; mean age ± standard deviation, 45 ± 12 years; 133 with gastroparesis) with chronic (>12 months) of refractory vomiting (idiopathic, associated with a type 1 or 2 diabetes, or postsurgical). A GES device was implanted and left unactivated until patients were randomly assigned, in a double-blind manner, to groups that received 4 months of stimulation parameters (14 Hz, 5 mA, pulses of 330 μs) or no stimulation (control); 149 patients then crossed over to the other group for 4 months. Patients were examined at the end of each 4-month period (at 5 and 9 months after implantation). Primary endpoints were vomiting score, ranging from 0 (daily vomiting) to 4 (no vomiting), and the quality of life, assessed by the Gastrointestinal Quality of Life Index scoring system. Secondary endpoints were changes in other digestive symptoms, nutritional status, gastric emptying, and control of diabetes.

Results: During both phases of the crossover study, vomiting scores were higher in the group with the device on (median score, 2) than the control group (median score, 1; P < .001), in diabetic and nondiabetic patients. Vomiting scores increased significantly when the device was ON in patients with delayed (P < .01) or normal gastric emptying (P = .05). Gastric emptying was not accelerated during the ON period compared with the OFF period. Having the GES turned on was not associated with increased quality of life.

Conclusions: In a randomized crossover study, we found that GES reduced the frequency of refractory vomiting in patients with and without diabetes, although it did not accelerate gastric emptying or increase of quality of life. Clinicaltrials.gov, Number: NCT00903799.
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http://dx.doi.org/10.1053/j.gastro.2019.10.018DOI Listing
February 2020

Economic burden of moderate to severe irritable bowel syndrome with constipation in six European countries.

BMC Gastroenterol 2019 May 7;19(1):69. Epub 2019 May 7.

Allergan International, Marlow, UK.

Background: Irritable bowel syndrome with predominant constipation (IBS-C) is a complex disorder with gastrointestinal and nervous system components. The study aim was to assess the economic burden of moderate to severe IBS-C in six European countries (France, Germany, Italy, Spain, Sweden and the UK).

Methods: An observational, one year retrospective-prospective (6 months each) study of patients diagnosed in the last five years with IBS-C (Rome III criteria) and moderate to severe disease at inclusion (IBS Symptom Severity Scale score ≥ 175). The primary objective was to assess the direct cost to European healthcare systems.

Results: Five hundred twenty-five patients were included, 60% (range: 43.1-78.8%) suffered from severe IBS-C. During follow-up 11.1-24.0% of patients had a hospitalisation/emergency room (ER) visit, median stay range: 1.5-12.0 days and 41.1-90.4% took prescription drugs for IBS-C. 21.4-50.8% of employed patients took sick leave (mean: 11.6-64.1 days). The mean annual direct cost to the healthcare systems was €937.1- €2108.0. The total direct cost (combined costs to healthcare systems and patient) for IBS-C was €1421.7-€2487.1.

Conclusions: IBS-C is not a life-threatening condition; however, it has large impact on healthcare systems and society. Direct and indirect costs for moderate to severe IBS-C were high with the largest direct cost driver being hospitalisations/ER visits.
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http://dx.doi.org/10.1186/s12876-019-0985-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6505116PMC
May 2019

CNCM I-745 Modulates the Fecal Bile Acids Metabolism During Antimicrobial Therapy in Healthy Volunteers.

Front Microbiol 2019 4;10:336. Epub 2019 Mar 4.

Inserm UMR1149, DHU Unity - Paris Diderot University, Paris, France.

CNCM I-745 (SB) is a probiotic yeast used to lower the incidence of antibiotic-associated () infection, though its mechanism of action remains unclear. Cholic acid is a primary bile acid, which triggers the germination and promotes the growth of . The intestinal microbiota transforms primary into secondary bile acids. This study examined (1) the antimicrobial-induced alteration of fecal bile acid content, and (2) whether the concomitant administration of SB influences this transformation. This is an ancillary work from a randomized study, which revealed that SB modulates fecal microbiota dysbiosis during antibiotic treatment. Healthy subjects were randomly assigned to (1) SB only, (2) amoxicillin-clavulanate (AC), (3) SB plus AC, or (4) no treatment. We analyzed fecal concentrations of BA by high performance liquid chromatography/tandem mass spectrometry. Compared to the untreated or the SB-treated groups, AC decreased the percentage of fecal secondary BA significantly (days 3 and 7). When SB and AC were administered concomitantly, this decrease in secondary BA was no longer significant. Following treatment with AC, a significant peak of fecal CA was measured on days 3 and 7, which was prevented by the concomitant administration of SB. AC administered to healthy volunteers altered the microbial transformation of primary BA, decreased secondary BA, and increased CA. The latter was prevented by the concomitant administration of SB and AC, suggesting a potent mechanism protection conferred by SB against post-antimicrobial infection. www.ClinicalTrials.gov, identifier NCT01473368.
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http://dx.doi.org/10.3389/fmicb.2019.00336DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6407479PMC
March 2019

Inhibitory Effect of Ursodeoxycholic Acid on Germination Is Insufficient to Prevent Colitis: A Study in Hamsters and Humans.

Front Microbiol 2018 22;9:2849. Epub 2018 Nov 22.

INSERM U1149, Centre de Recherche sur l'Inflammation, Faculté de Médecine Paris Diderot, Université Paris Diderot, Paris, France.

Bile acids (BA) influence germination and growth of . Ursodeoxycholic acid (UDCA), a BA minor in human, used for cholestatic liver diseases, inhibits germination and growth of , but was never tested with an infectious challenge versus control. We hypothesized that UDCA could prevent CDI. We evaluated the effects of UDCA on and in hamsters, with pharmacokinetics study and with an infectious challenge. Then, we studied CDI incidence in UDCA-treated patients. We evaluated germination and growth of , with 0.01, 0.05, and 0.1% UDCA. We analyzed fecal BA of hamsters receiving antibiotics and UDCA (50 mg/kg/day), antibiotics, or UDCA alone. Then, we challenged with spores of at D6 hamsters treated with UDCA (50 mg/kg/day) from D1 to D13, versus control. In human, we analyzed the database of a cohort on CDI in acute flares of inflammatory bowel disease (IBD). As PSC-IBD patients were under UDCA treatment, we compared PSC-IBD patients to IBD patients without PSC. , UDCA inhibited germination and growth of at 0.05 and 0.1%, competing with 0.1% TCA (with 0.1%: 0.05% ± 0.05% colony forming unit versus 100% ± 0%, < 0.0001). In hamsters, UDCA reached high levels only when administered with antibiotics (43.5% UDCA at D5). Without antibiotics, UDCA was in small amount in feces (max. 4.28%), probably because of UDCA transformation into LCA by gut microbiota. During infectious challenge, mortality was similar in animals treated or not with UDCA (62.5%, = 5/8, = 0.78). UDCA percentage was high, similar and with the same kinetics in dead and surviving hamsters. However, dead hamsters had a higher ratio of primary over secondary BA compared to surviving hamsters. 9% ( = 41/404) of IBD patients without PSC had a CDI, versus 25% ( = 4/12) of PSC-IBD patients treated with UDCA. We confirmed the inhibitory effect of UDCA on growth and germination of , with 0.05 or 0.1% UDCA. However, in our hamster model, UDCA was inefficient to prevent CDI, despite high levels of UDCA in feces. Patients with PSC-IBD treated with UDCA did not have less CDI than IBD patients.
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http://dx.doi.org/10.3389/fmicb.2018.02849DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6262072PMC
November 2018

Efficacy and Safety of Intra-gastric Balloon Placement in Dialyzed Patients Awaiting Kidney Transplantation.

Obes Surg 2019 02;29(2):713-720

Department of Nephrology Dialysis, Transplantation, IFRNT, University of Paris-Sud, Le Kremlin Bicetre, France.

Background: The number of obese patients who are candidates for renal transplantation has considerably increased, but obesity can be a barrier to kidney transplantation. Weight loss is often difficult through diet alone. We studied the efficacy and tolerance of the intra-gastric balloon (IGB) procedure in obese patients who were undergoing dialysis and were candidates for a renal transplantation.

Patients And Methods: Obese patients (BMI > 30 kg/m) who were candidates for renal transplantation were prospectively included in the study between 2010 and 2012. The balloon was inserted and removed during a gastric endoscopy under general anesthesia. The treatment lasted 6 months. The end point was a decrease in BMI after 6 months. Body impedance spectrometry (BIS) and nutritional statute were evaluated initially and then after IGB removal.

Results: Seventeen patients (nine females and eight males) with a mean age of 53.4 years [19.4-69.4] were included. The decrease in body mass index (BMI) during the 6-month placement was 3 kg/m (from 37.7 to 34.4 kg/m). The mean weight loss was 7 kg. The mean percentage of excess weight loss after 6 months was 20.2 (± 11.4). The tolerance was good without any complications. Eleven patients underwent kidney transplantation.

Conclusion: IGB in obese dialyzed patients who are candidates for renal transplantation is safe and effective. However, the amount of weight loss can vary.
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http://dx.doi.org/10.1007/s11695-018-3574-4DOI Listing
February 2019

Association between two painful and poorly understood conditions: Irritable bowel and sensitive skin syndromes.

Eur J Pain 2019 01 4;23(1):160-166. Epub 2018 Sep 4.

EMMA, Fontenay-sous-Bois, France.

Background: Irritable bowel and sensitive skin syndromes are common painful conditions that are poorly understood, with alterations of the peripheral (and possibly central) nervous system that lead to a lowering of perception thresholds as the main pathophysiological mechanism.

Methods: A cross-sectional epidemiological study was carried out on a representative sample of French people, according to the quota method using a questionnaire.

Results: Among the 5,000 respondents, 48.9% were men and 51.1% were women. According to the adapted Rome questionnaire, 14.6% suffered from irritable bowel syndrome. A total of 59.1% declared very sensitive or sensitive skin. A total of 73.1% of subjects had irritable bowel syndrome versus 52.3% in the other group without an irritable colon (p < 0.001). Similarly, the frequency of irritable bowel syndrome symptoms was associated with the severity of sensitive skin syndrome. The presence of sensitive skin was highly associated with the presence of abdominal pain or discomfort, with an OR of 1.93 after adjustment for sex and age.

Conclusions: This study is the first study showing an association between sensitive skin and irritable bowel syndromes. Sensory symptoms are predominant in these two syndromes and transit disorders in one case and vasomotor disorders in the other could probably be considered as pathophysiological equivalents.

Significance: The demonstration of the association between these two syndromes can open new pathophysiological or even therapeutic pathways, since dysfunctional nerve endings and/or increased release of some neurotransmitters are likely involved.
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http://dx.doi.org/10.1002/ejp.1296DOI Listing
January 2019

Clinical impact of upper gastrointestinal endoscopy in critically ill patients with suspected bleeding.

Ann Intensive Care 2018 Jul 4;8(1):75. Epub 2018 Jul 4.

Medico-Surgical Intensive Care Unit, AP-HP, Hôpital Louis Mourier, 178 rue des Renouillers, 92700, Colombes, France.

Background And Aims: Upper gastrointestinal endoscopies' (UGE) profitability is undisputable in patients admitted for an overt upper digestive tract bleeding. In critically ill subjects admitted for other causes, its performances have scarcely been investigated despite its broad use. We sought to question the performance of bedside UGE in intensive care unit (ICU) patients, admitted for another reason than overt bleeding.

Methods: This was a six-year (January 2007-December 2012) retrospective observational study of all UGE performed in a medico-surgical ICU. Exclusion of those performed: in patients admitted for a patent upper digestive bleeding; for a second-look gastroscopy of a known lesion; as a planned interventional procedure. Main demographic and clinical data were recorded; UGE indication and profitability were rated according to its findings and therapeutic impact. Operative values of the indications of UGE were calculated. This study received approval from the Ethics Committee of the French Society of Intensive Care (n° 12-363).

Results: Eighty-four patients (74% male, mean age 61 ± 14 years) underwent a diagnostic UGE, all for a suspected upper digestive tract bleeding. The main symptoms justifying the procedure were anemia (52%), digestive bleeding (27%), vomiting (15%), hemodynamic instability (3%) and hyperuremia (3%). The profitability of UGE was rated as major (n = 5; 5.8%); minor (n = 34; 40.5%); or null (n = 45; 53.6%).

Conclusions: When ICU admission is not warranted by a digestive bleeding, UGE has limited diagnostic and therapeutic interest, despite being often performed.
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http://dx.doi.org/10.1186/s13613-018-0423-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6031555PMC
July 2018

Roux-en-Y Gastric-Bypass and sleeve gastrectomy induces specific shifts of the gut microbiota without altering the metabolism of bile acids in the intestinal lumen.

Int J Obes (Lond) 2019 02 30;43(2):428-431. Epub 2018 Jan 30.

Sorbonne Universités, UPMC Univ. Paris 06, École normale supérieure, PSL Research University, CNRS, INSERM, APHP, Laboratoire des Biomolécules (LBM), 27 rue de Chaligny, Paris, 75005, France.

Some shifts in the gut microbiota composition and its metabolic fingerprints have been associated to Sleeve gastrectomy (SG) and Roux-en-Y Gastric Bypass (RYGB). So far, plasma bile acids have been associated with post-operative glucose improvement and weight loss, but nothing is known about their metabolism in the gut lumen. As bile acids are physiologically transformed by the microbiota into various species, the aim of this work was to study how SG and RYGB-associated dysbiosis impact the bioconversion of bile acids in the intestinal lumen. Comparing SHAM (n = 9) with our validated rat models of SG (n = 5) and RYGB (n = 6), we quantified luminal bile acids along the gut and found that the metabolic transformation of bile acids (deconjugation, dehydroxylation, and epimerization) is not different from the duodenum to the colon. However, in the cecum where the biotransformation mainly takes place, we observed deep alterations of the microbiota composition, which were specific of each type of surgery. In conclusion, despite specific dysbiosis after surgery, the bile acids metabolism in the gut lumen is highly preserved, suggesting that a resilience of the gut microbiota occurs after these procedures.
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http://dx.doi.org/10.1038/s41366-018-0015-3DOI Listing
February 2019

Clinical practice guidelines from the French National Society of Coloproctology in treating chronic constipation.

Eur J Gastroenterol Hepatol 2018 04;30(4):357-363

Gastroenterology Unit, Pontchaillou Hospital, Rennes 1 University.

Chronic constipation is a common symptom that regularly affects the quality of life of adult patients. Its treatment is mainly based on dietary rules, laxative drugs, perineal rehabilitation and surgical treatment. The French National Society of Coloproctology offers clinical practice recommendations on the basis of the data in the current literature, including those on recently developed treatments. Most are noninvasive, and the main concepts include the following: stimulant laxatives are now considered safe drugs and can be more easily prescribed as a second-line treatment; biofeedback therapy remains the gold standard for the treatment of anorectal dyssynergia that is resistant to medical treatment; transanal irrigation is the second-line treatment of choice in patients with neurological diseases, but it may also be proposed for patients without neurological diseases; and although interferential therapy may be a new promising treatment, it needs further evaluation.
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http://dx.doi.org/10.1097/MEG.0000000000001080DOI Listing
April 2018

Gastroesophageal Reflux After Sleeve Gastrectomy: a Prospective Mechanistic Study.

Obes Surg 2018 03;28(3):838-845

Service des Explorations Fonctionnelles and Centre Intégré Nord Francilien de prise en charge de l'Obésité (CINFO), Hôpital Louis Mourier (AP-HP) and Université Paris Diderot, Sorbonne Paris Cité, France.

Background: Evolution of gastroesophageal reflux disease (GERD) after sleeve gastrectomy (SG) is controversial. Some authors report worsening or improvement of preoperative GERD, others the occurrence of de novo GERD between 5 and 69%.

Aims: The aims of this study are to evaluate the evolution of GERD after SG by ambulatory 24-h pH monitoring (APM) and to determine pre- and postoperative clinical and manometric factors associated with its evolution.

Methods: Between 2013 and 2015, 47 patients operated in our center performed APM before and 1 year (14.8 ± 4.9 months) after SG. GERD was defined as a percentage of time with esophageal pH < 4 (TpH < 4) > 4.2. Among them, 30 had pre- and postoperative high-resolution esophageal manometry (HRM).

Results: Thirty-one patients (66%) had no preoperative GERD (group 1), and 16 had preoperative GERD (group 2). One year after SG, mean TpH < 4 increased significantly in group 1 (5.8 ± 4.6 vs. 1.8 ± 1.1%, p < 0.01) whereas it was not modified in group 2 (7.4 ± 6.6 vs. 6.6 ± 2.6%). In group 1, 16 patients (52%) had de novo GERD whereas in group 2, 7 had no more GERD, 3 improved, and 6 worsened. Maximal intragastric pressure after swallows increased significantly at postoperative HRM only in patients with de novo GERD (49.2 ± 22.0 vs. 25.4 ± 9.4 mmHg, p = 0.03). No preoperative clinical or manometric parameters were predictive of postoperative GERD.

Conclusions: One year after SG, esophageal acid exposure globally worsened, mostly because of de novo GERD, whereas 63% patients with preoperative GERD improved, without preoperative predictive clinical or manometric factor.
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http://dx.doi.org/10.1007/s11695-017-2942-9DOI Listing
March 2018

Outcomes 7 Years After Infliximab Withdrawal for Patients With Crohn's Disease in Sustained Remission.

Clin Gastroenterol Hepatol 2018 02 7;16(2):234-243.e2. Epub 2017 Oct 7.

Gastroenterology Department, Centre Hospitalier Universitaire de Liège, Liège, Belgium.

Background & Aims: Little is known about long-term outcomes of patients with Crohn's disease (CD) after infliximab withdrawal. We aimed to describe the long-term outcomes of patients with CD in clinical remission after infliximab treatment was withdrawn.

Methods: We performed a retrospective analysis of data from the 115 patients included in the infliximab discontinuation in patients with CD in stable remission on combined therapy with antimetabolites (STORI) study, performed at 20 centers in France and Belgium from March 2006 through December 2009. The STORI cohort was a prospective analysis of risk and factors associated with relapse following withdrawal of maintenance therapy with infliximab, maintained on antimetabolites, while in clinical remission. We collected data from the end of the study until the last available follow-up examination on patient surgeries, new complex perianal lesions (indicating major complications), and need for and outcomes of restarting therapy with infliximab or another biologic agent. The de-escalation strategy was considered to have failed when a major complication or infliximab restart failure occurred.

Results: Of the 115 patients initially included, data from 102 patients (from 19 of the 20 study centers) were included in the final analysis. The median follow-up time was 7 years. Twenty-one percent of the patients did not restart treatment with infliximab or another biologic agent and did not have a major complication 7 years after infliximab withdrawal (95% CI, 13.1-30.3). Among patients who restarted infliximab, treatment failed for 30.1% 6 years after restarting (95% CI, 18.5-42.5). Overall, at 7 years after stopping infliximab therapy, major complications occurred in 18.5% of patients (95% CI, 10.2-26.8) whereas 70.2% of patients had no failure of the de-escalation strategy (95% CI, 60.2-80.1). Factors independently associated with major complications were upper-gastrointestinal location of disease, white blood cell count ≥ 5.0 × 10/L, and hemoglobin level ≤12.5 g/dL at the time of infliximab withdrawal. Patients with at least 2 of these factors had a more than 40% risk of major complication in the 7 years following infliximab withdrawal.

Conclusions: In a long-term follow-up of the STORI cohort (7 years) one fifth of the patients did not restart infliximab or another biologic agent and did not develop major complications. Seventy percent of patients had no failure of the de-escalation strategy (no major complication and no failure of infliximab restart).
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http://dx.doi.org/10.1016/j.cgh.2017.09.061DOI Listing
February 2018

Oral Prolonged-Release Oxycodone/Naloxone for Managing Pain and Opioid-Induced Constipation: A Review of the Evidence.

Pain Pract 2018 06 28;18(5):647-665. Epub 2017 Nov 28.

Marymount University Hospital and Hospice, Cork, Ireland.

Background: Opioids provide effective relief from moderate-to-severe pain and should be prescribed as part of a multifaceted approach to pain management when other treatments have failed. Fixed-dose oxycodone/naloxone prolonged-release tablets (OXN PR) were designed to address the opioid class effect of opioid-induced constipation (OIC) by combining the analgesic efficacy of oxycodone with the opioid receptor antagonist, naloxone, which has negligible systemic availability when administered orally. This formulation has abuse-deterrent properties, since systemic exposure to naloxone by parenteral administration would antagonize the euphoric effects of oxycodone.

Methods: A literature search was conducted to assess the evidence base for OXN PR to treat moderate-to-severe pain and its impact on bowel function, based on published clinical trials and observational studies.

Results: Extensive data demonstrate that OXN PR provides effective analgesia and clinically relevant improvements in bowel function in patients with OIC and moderate-to-severe cancer-related pain and noncancer pain types such as low back pain, neuropathic pain, and musculoskeletal pain. OXN PR has also been found to improve bowel function in patients with OIC refractory to multiple types of laxatives, and improve Parkinson's disease-related pain. No unanticipated safety concerns have been reported in elderly patients.

Conclusions: Evidence from clinical trials and observational studies confirms that for selected patients OXN PR significantly improves moderate-to-severe chronic pain and provides relief from OIC. Treatment should be tailored to individual patients to establish the lowest effective dose. An absence of analgesic ceiling effect was seen across the clinically relevant dose range investigated (≤ 160/80 mg/day).
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http://dx.doi.org/10.1111/papr.12646DOI Listing
June 2018
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