O. Le Moine

Safety, feasibility and weight loss after transoral gastroplasty: First human multicenter study

ObjectiveTo evaluate the safety and feasibility in human subjects of a new transoral restrictive procedure for the treatment of obesity.MethodsThe protocol was approved by the institutional review boards (IRBs) of both centers involved, and all patients gave informed consent. Patients met established inclusion criteria for bariatric surgery. The TOGa system (Satiety Inc., Palo Alto, CA), a set of transoral endoscopically guided staplers, was used to create a stapled restrictive pouch along the lesser curve of the stomach. Patients were hospitalized overnight for observation and underwent barium upper gastrointestinal (UGI) the next morning. Post procedure, all patients were placed on a liquid diet for 1 month and asked to begin an exercise program. Follow-up was carried out at 1 week and 1, 3, 4, 5, and 6 months.ResultsTwenty one patients were enrolled [17 female, age 43.7 (22–57) years, BMI 43.3 (35–53) kg/m2]. Device introduction was completed safely in all patients. There were no serious adverse events (AEs). The most commonly reported procedure or device related adverse events were vomiting, pain, nausea, and transient dysphagia. At 6 month endoscopy, all patients had persistent full or partial stapled sleeves. Gaps in the staple line were evident in 13 patients. Patients lost an average 17.6 pounds at 1 month, 24.5 pounds at three months, and 26.5 pounds at 6 months post-treatment [excess weight loss (EWL) of 16.2%, 22.6%, and 24.4%, respectively].ConclusionsThere is great interest in new procedures for morbid obesity that could offer lower morbidity than current options. Early experience with the TOGa procedure indicates that this transoral approach may be safe and feasible. Further experience with the device and technique should improve anatomic and functional outcomes in the future. Additional studies are underway.

Transoral gastroplasty is safe, feasible, and induces significant weight loss in morbidly obese patients: results of the second human pilot study

BACKGROUND AND STUDY AIMS Bariatric surgical treatments have been proven to induce long-term weight loss in morbidly obese patients, but complications are relatively frequent. We recently reported a first human multicenter trial assessing the safety, feasibility, and weight loss results of the Transoral Gastroplasty (TOGA) system (Satiety Inc., Palo Alto, CA) at 6 months. Here we report the 6-month results of the second phase of the pilot trial with the TOGA system, with technical improvements to the device. PATIENTS AND METHODS Patients met established criteria for bariatric surgery. The TOGA system, a set of transoral endoscopically guided staplers, was used to create a stapled restrictive pouch along the lesser curvature of the stomach. Follow-up was at 1 week and at 1, 3, and 6 months. At 3 months, re-treatment consisting in additional distal restrictions was allowed if necessary. RESULTS Data were available for 11 patients in our center (7 female, mean age 44.2 years, mean body mass index 41.6). The procedure was completed safely in all patients. There were no serious adverse events. Mean excess weight loss was 19.2 %, 33.7 %, and 46.0 % at 1, 3, and 6 months, respectively. Average body mass index decreased from 41.6 before treatment to 33.1 at 6 months. Absolute mean weight loss was 9.9 kg, 17.5 kg, and 24.0 kg at 1, 3, and 6 months, respectively. A dramatic improvement in quality-of-life measures was observed in all patients. CONCLUSIONS This second pilot trial confirmed the feasibility and safety of transoral gastroplasty. The early results and technical improvements reported in the present study are encouraging in terms of safety, early weight loss, and quality of life, and clearly allowed multicenter trials, which are planned to start soon.

Factors related to early mortality in cirrhotic patients bleeding from varices and treated by urgent sclerotherapy.

Variceal haemorrhage in cirrhotic patients carries a high early mortality even when balloon tamponade or emergency sclerotherapy are applied. The aim of this study to identify patients dying within six weeks of their first variceal haemorrhage. One hundred and twenty one patients with parenchymal cirrhosis presenting with the first variceal bleeding episode between June 1983 and December 1988 were studied. Nineteen patients were excluded for various reasons. Emergency sclerotherapy was carried out in cases of active bleeding or where there were endoscopic signs of recent bleeding, and then regularly repeated afterwards. Of the 24 variables studied and included in a multivariate analysis using a logistic regression model, three had an independent prognostic value: encephalopathy, prothrombin time, and the number of blood units transfused within the 72 hours of time zero. The subsequent regression equation was able to predict 89% of the patients who will die and 97% of the patients who will still be alive six weeks after their first variceal haemorrhage treated by sclerotherapy. Pugh score was less discriminatory than these last three variables in terms of accuracy of adjustment, goodness of fit to the model, receiver operating characteristic curves, and percentage correct prediction. To measure the accuracy of the prediction rule, our model was applied to another series of 28 cirrhotic patients admitted with their first variceal bleeding during the next period (January 1989 to May 1990). Death and survival were correctly predicted in respectively 82% and 94% of the cases. The use of this score is recommended for the selection of patients with high early mortality after variceal bleeding despite sclerotherapy, and for the design of new therapeutic trials.

Intraductal optical coherence tomography during endoscopic retrograde cholangiopancreatography for investigation of biliary strictures

BACKGROUND AND STUDY AIMS Optical coherence tomography (OCT) uses infrared light reflectance to produce high-resolution cross-sectional tissue images. The aim of this study was to demonstrate the feasibility of biliary intraductal OCT during endoscopic retrograde cholangiopancreatography (ERCP) and to assess the potential of the method to detect malignant biliary strictures. PATIENTS AND METHODS Thirty-seven patients with biliary strictures were studied during therapeutic ERCP. Malignant strictures were defined as those that demonstrated malignant cells in brushing and/or biopsy specimens, and/or endoscopic ultrasound-guided fine-needle aspiration and/or surgery. Strictures that did not have malignant cells in resected specimens and were without clinical/radiological evidence of disease progression for at least a 12-month follow-up period were considered as benign. Two OCT criteria for malignancy were considered: unrecognizable layer architecture; and presence of large, nonreflective areas compatible with tumor vessels. Sensitivity and specificity for brushings/biopsies as well as OCT criteria were calculated. RESULTS Nineteen patients had malignant and 16 had benign strictures. In two patients, OCT assessment could not be performed due to tight strictures. Malignancy was confirmed by biliary brushings/biopsies in 12/19 (63 %) patients. OCT revealed that two malignancy criteria were encountered in 10/19 (53 %) and at least one criterion in 15/19 (79 %) patients with malignant strictures. No patient with benign stricture met both criteria and 5/16 met one criterion (31 %). Combining brushings/biopsy with the observation of at least one OCT criterion resulted in the diagnosis of malignancy in 16/19 (84 %) patients. CONCLUSIONS OCT may improve the sensitivity and diagnostic accuracy of biliary brushings/biopsies alone.

Relationship between Portal Pressure, Esophageal Varices, and Variceal Bleeding on the Basis of the Stage and Cause of Cirrhosis

BACKGROUND AND METHODS Hepatic venous pressure gradient, esophageal varices, and variceal bleeding were investigated in 957 patients with cirrhosis. The causes (alcoholic/virus) and stage (Child-Pughs classification) of cirrhosis were also taken into account. RESULTS The prevalence of variceal bleeding was 35% in patients with large varices and 17% in those with small varices (P < 0.05). It was higher in patients with alcoholic cirrhosis (41% and 19%, respectively) than in those with viral cirrhosis (22% and 10%, respectively). In patients with alcoholic cirrhosis the hepatic venous pressure gradient was higher in Child A and B patients with small or large varices than in those with no varices; these differences were not found in Child C patients and in patients with viral cirrhosis. In all subgroups the pressure gradient was higher in Child C patients than in Child A patients. There was no significant difference in the hepatic venous pressure gradient between patients with varices and previous variceal bleeding and those with no bleeding whatever the stage of cirrhosis. CONCLUSIONS This study shows that the hepatic venous pressure gradient is associated with the stage and causes of cirrhosis and the presence of varices. These factors should be taken into account in studies evaluating the hepatic venous pressure gradient in heterogeneous groups of patients.

Transjugular Intrahepatic Portosystemic Stent Shunt as a Rescue Treatment after Sclerotherapy Failure in Variceal Bleeding

BACKGROUND Variceal bleeding carries high early mortality, especially after failure of conventional treatments such as endoscopic injection therapy. The present study analyses the efficacy of transjugular intrahepatic portosystemic stent shunt (TIPS) in cirrhotic patients after failure of sclerotherapy for variceal bleeding. METHODS Twenty-four consecutive patients underwent TIPS in this indication. RESULTS The procedure was successful in all patients, with reduction of size or disappearance of varices in 96% of them. Four patients (17%) developed encephalopathy and six (25%) rebled during the follow-up period (median 5 months; range 1-19). Thirty-day mortality was only 17% and 29% during the follow-up period. Deaths were mainly due to liver failure, especially after procedures performed in emergency. Significant decrease in liver function was observed in the days following the procedure. To maintain long-term patency of the shunt, revision was required in nine patients (38%). CONCLUSIONS TIPS seems to be a promising salvage therapeutic procedure after failed sclerotherapy, but this needs to be addressed in controlled trials.

Appropriateness of colonoscopy in Europe (EPAGE II) – Iron-deficiency anemia and hematochezia

BACKGROUND AND STUDY AIMS To summarize the published literature on assessment of appropriateness of colonoscopy for the investigation of iron-deficiency anemia (IDA) and hematochezia, and report appropriateness criteria developed by an expert panel, the 2008 European Panel on the Appropriateness of Gastrointestinal Endoscopy, EPAGE II. METHODS A systematic search of guidelines, systematic reviews and primary studies regarding the evaluation and management of IDA and hematochezia was performed. The RAND/UCLA Appropriateness Method was applied to develop appropriateness criteria for colonoscopy for these conditions. RESULTS IDA occurs in 2 %-5 % of adult men and postmenopausal women. Examination of both the upper and lower gastrointestinal tract is recommended in patients with iron deficiency. Colonoscopy for IDA yields one colorectal cancer (CRC) in every 9-13 colonoscopies. Hematochezia is a well-recognized alarm symptom and such patients are likely to be referred for colonoscopy. Colonoscopy is unanimously recommended in patients aged > or = 50. Diverticulosis, vascular ectasias, and ischemic colitis are common causes of acute lower gastrointestinal bleeding (LGIB); CRC is found in 0.2 %-11 % of the colonoscopies performed for LGIB. Most patients with scant hematochezia have an anorectal or a distal source of bleeding. The expert panel considered most clinical indications for colonoscopy as appropriate in the presence of IDA (58 %) or hematochezia (83 %). CONCLUSION Despite the limitations of the published studies, guidelines unanimously recommend colonoscopy for the investigation of IDA and hematochezia in patients aged > or = 50 years. These indications were also considered appropriate by EPAGE II, as were indications in patients at low risk for CRC with no obvious cause of bleeding found during adequate previous investigations.

A new partially covered nitinol stent for palliative treatment of malignant bile duct obstruction: a multicenter single-arm prospective study

BACKGROUND AND STUDY AIMS Covered self-expanding metal stents (SEMSs) have proven effective for managing malignant bile duct strictures and may reduce risk of tumor ingrowth. A new nitinol partially covered biliary SEMS was prospectively evaluated. PATIENTS AND METHODS 70 patients with inoperable extrahepatic biliary obstructions were enrolled in a prospective multicenter trial, and followed up to 6 months or death, whichever came first. Primary endpoint was adequate palliation defined as absence of recurrent biliary obstruction from partly covered SEMS placement to end of follow-up. RESULTS Mean age of the patients was 69 years and 52 % were men. Pancreatic carcinoma was present in 68 %. One stent was placed in 67 patients, two patients received two, and in one patient a guide wire could not traverse the stricture. In 55 % of patients the SEMS was inserted de novo and in 45 % for exchange with a plastic stent. Technical success was 97 %. At 6 months, 62 % of patients were free of obstructive symptoms; compared with baseline the mean number of symptoms per patient was significantly reduced (3.1 at baseline, 0.6 at 6 months; P < 0.0001) and total bilirubin levels dropped by 73 %. There were four cases of recurrent biliary obstruction, due to stent migration (2), tumor overgrowth (1), and sludge formation (1). Device-related complications included cholecystitis (3), right upper quadrant pain (1), and moderate pancreatitis (1). No tumor ingrowth was reported. CONCLUSIONS This new partially covered nitinol SEMS is easily inserted, and safe and effective in the palliation of biliary obstruction secondary to malignant bile duct strictures.

Percutaneous endoscopic jejunostomy in patients with gastroparesis following lung transplantation: feasibility and clinical outcome.

The aim of the present study was to describe success rates, complications, and outcome in patients who underwent percutaneous endoscopic jejunostomy (PEJ) because of gastroparesis due to previous lung transplantation. Between October 2008 and May 2011, 14 attempts at PEJ placement were made in 12 patients in our center. Of the 14 attempts, 11 were successful, giving a technical success rate of 78.6 %. Median duration of followup was8.5 months (2–15 months). No immediate complications were reported. Two severe complications occurred during follow up (one volvulus and one jejunocolic fistula). Jejunal nutrition was well tolerated in most of patients (9 /10). PEJ insertion is a feasible technique, which could help to provide nutritional support for patients with gastroparesis and previous lung transplantation.

Unexplained digestive bleeding in a cirrhotic patient

A 50 year old White man with cirrhosis due to hepatitis C virus (HCV) infection was admitted to our hospital for severe anaemia and intermittent melena. At admission, haemoglobin was …