Antireflux versus conventional self-expanding metallic Stents (SEMS) for distal esophageal cancer: results of a multicenter randomized trial.

INTRODUCTION: Self-expanding metal stents (SEMS) are commonly used in the palliation of dysphagia in patients with inoperable esophageal carcinoma. However, they predispose to gastroesophageal reflux when deployed across the gastroesophageal junction. The aims of this study were to: 1) assess the influence of the antireflux valve on trans-prosthetic reflux (primary outcome); and 2) compare the results of SEMS with and without antireflux valve in terms of reflux symptoms, quality of life (QOL), improvement of dysphagia and adverse events (secondary outcomes). PATIENTS AND METHODS: Thirty-eight patients were enrolled in nine centers. Carcinomas were locally advanced (47 %) or metastatic. After randomization, patients received either a covered SEMS with antireflux valve (n = 20) or a similar type of SEMS with no antireflux device but assigned to standard proton pump inhibitor therapy and postural advice (n = 18). Trans-prosthetic reflux was assessed at day 2 using a radiological score based on barium esophagography performed after Trendelenburg maneuver and graded from 0 (no reflux) to 12 (maximum). Monthly telephone interviews were conducted for Organisation Mondiale de la Santé (OMS) scoring from 0 (excellent) to 5 (poor), QOL assessment (based on the Reflux-Qual Simplifié scoring system) from 0 (poor) to 100 (excellent), dysphagia scoring from 0 (no dysphagia) to 5 (complete dysphagia) and regurgitation scoring from 0 (no regurgitation) to 16 (maximum). RESULTS: No difference was noted in terms of age, sex, size of lesion, prosthesis length or need for dilation prior to SEMS placement. No difficulty in placing SEMS nor complications were noted. Radiological scores of reflux were found to be significantly lower in patients with an antireflux stent compared to the conventional stent and associated measures. The regurgitation scores were significantly decreased in patients with antireflux stents during the first 2 months after stent placement and thereafter, they were similar in the two groups. QOL and dysphagia were improved in both groups. Survival rates were comparable in the two groups. CONCLUSIONS: No difference was observed between the two types of SEMS regarding the palliation of dysphagia and improvement of QOL. However, SEMS with an antireflux valve were more effective in preventing trans-prosthetic gastroesophageal reflux but at the cost of an increased likehood of minor adverse events (migrations and/or obstruction of the SEMS).

Endoscopic submucosal dissection in a European setting. A multi-institutional report of a technique in development.

BACKGROUND AND STUDY AIMS: Endoscopic submucosal dissection (ESD) is a technique for "en bloc" resection of superficial tumors of the gastrointestinal tract. In France, experience with this technique is still limited. We wanted to assess the development of ESD in France, with special attention to short term outcomes. PATIENTS AND METHODS: Members of the Société Française d'Endoscopie Digestive (SFED) who declared performing ESD reported their cases prospectively on a voluntary basis. Demographic, clinical, and technical data, and the results of immediate complications were collected. Case reports were completed prospectively by each investigator before pooled analysis. RESULTS: A total of 188 consecutive case reports were collected from 16 centers. The median case mix per center was 6 patients (range 1-43). The lesion sites treated by ESD were the stomach (n = 75), esophagus (n = 27), duodenum (n = 1), cecum (n = 2), right colon (n = 3), transverse colon (n = 5), sigmoid (n = 3), and rectum (n = 72). The median size of the lesions was 26 mm (range 2-150 mm). En bloc resection was achieved in 77.1% of cases, with complete R0 resection in 72.9%. Histopathology results showed high grade dysplasia or superficial cancer in 71.2%. The median duration of ESD was 105 minutes (range 20-450 minutes). The short term morbidity was 29.2% including 34 cases of perforation (18.1%), and 21 hemorrhages (11.2%) during the 24 hours following ESD, 89% of which were managed conservatively or endoscopically. CONCLUSION: In this early experience, the feasibility of ESD appeared to be good but R0 resection and complication rates did not match those reported by Japanese authors and must be improved by an extended practice.

Colon capsule endoscopy vs. colonoscopy in patients at average or increased risk of colorectal cancer.

BACKGROUND: Colon capsule endoscopy (CCE) is a new, non-invasive technology. AIM: To conduct a prospective, multicentre trial to compare CCE and colonoscopy in asymptomatic subjects enrolled in screening or surveillance programmes for the detection of colorectal neoplasia. METHODS: Patients underwent CCE on day one and colonoscopy (gold standard) on day two. CCE and colonoscopy were performed by independent endoscopists. RESULTS: A total of 545 patients were recruited. CCE was safe and well-tolerated. Colon cleanliness was excellent or good in 52% of cases at CCE. Five patients with cancer were detected by colonoscopy, of whom two were missed by CCE. CCE accuracy for the detection of polyps ≥ 6 mm was 39% (95% CI 30-48) for sensitivity, 88% (95% CI 85-91) for specificity, 47% (95% CI 37-57) for positive predictive value and 85% (95% CI 82-88) for negative predictive value. CCE accuracy was better for the detection of advanced adenoma, in patients with good or excellent cleanliness and after re-interpretation of the CCE videos by an independent expert panel. CONCLUSIONS: Although well-tolerated, CCE cannot replace colonoscopy as a first line investigation for screening and surveillance of patients at risk of cancer. Further studies should pay attention to colonic preparation (Clinicaltrial.gov number NCT00436514).

A national survey of endoscopic mucosal resection for superficial gastrointestinal neoplasia.

BACKGROUND AND STUDY AIM: Studies on endoscopic mucosal resection (EMR) are mostly based on data from centers with high expertise. We report the average EMR results in a national survey of consecutive patients in France. METHODS: A 1-year survey was carried out to record immediate outcome data of all EMRs performed, regardless of lesion size or gastrointestinal location. RESULTS: Overall, 1335 EMRs in 1210 patients were reported by 241 of the 736 gastroenterologists who performed such procedures (33 %). Resections were done for upper gastrointestinal lesions in 125 cases (41 esophageal, 43 gastric, and 41 duodenal lesions), in 45 % of cases using specific EMR techniques such as ligation, cap, or traction. The technique for resecting the 1210 lower gastrointestinal lesions mostly consisted of saline-assisted polypectomy or EMR, with specific techniques used in only 2.2 %. En bloc resection was less common with esophageal (46 %) or duodenal (54 %) neoplasms than in the lower gastrointestinal tract (73 %); size also had some influence (53 % > 1 cm vs. 92 % ≤ 1 cm). The overall complication rate was 5.2 %; the rate was lower for lesions 1 cm or smaller (0.6 % vs. 4.6 %). Fifty-four early and 17 delayed complications were recorded, in 12 % of upper gastrointestinal and 4.6 % of colonic lesions. Surgery became necessary in 1.6 % for upper and 2.9 % for lower gastrointestinal neoplasms. No association was seen between physician EMR caseload and either en bloc resection rate or complication rate. CONCLUSIONS: EMR in general, especially saline-assisted polypectomy in the colon, appears to be reasonably safe even when performed by nonexperts. EMR for larger or for upper gastrointestinal lesions should probably be limited to high-volume centers.

The future of bariatrics: endoscopy, endoluminal surgery, and natural orifice transluminal endoscopic surgery.

This review considers the evolving role of endoscopic techniques in the treatment of obesity, and developments in minimally invasive procedures in endoscopy, endoluminal surgery and natural orifice transluminal endoscopic surgery (NOTES). Endoscopic approaches that are similar to surgery but less invasive, relying on gastric restriction and/or malabsorption, show some promise. Intragastric injection of botulinum toxin is also considered, as is the role of minimally invasive bariatric endoscopic interventions. Gastrointestinal stimulation with implanted electrodes may have potential in the treatment of obesity and endoscopic applications have a role to play in post-surgical interventions. Evolving research into endosurgical approaches is described. Current work on the feasibility of a NOTES approach to bariatric procedures is described.

Review of endoscopic devices for weight reduction: old and new balloons and implantable prostheses.

The worldwide epidemic of obesity is forecast to worsen with a concomitant increase in the burden of co-morbid conditions. Bariatric surgery has some disadvantages, and intragastric balloons (IGBs) represent a generally safe, reversible and less invasive approach to weight reduction, based on occupying gastric space to enhance the sensation of satiety. A literature review found that the majority of the published data on IGBs relates to the Bioenterics intragastric balloon (BIB). The evidence for the efficacy of the BIB as a primary means of weight loss is still unconvincing, but it appears to have value in subgroups of patients, for example to improve quality of life, ameliorate co-morbidities, or provide a bridge to surgery. Regarding other IGBs, even if there are promising weight loss results, more evidence and development is generally needed: it is difficult to evaluate the Heliosphere Bag because of the limited clinical experience; the Adjustable Totally Implantable Intragastric Prosthesis (ATIIP)-Endogast may have problems associated with the percutaneous endoscopic gastrotomy (PEG)-type insertion method; the Semistationary Antral Balloon (SAB) may require technical improvements; and the Silimed Gastric Balloon (SGB) warrants further investigation. Another implantable device, the endoscopic duodenal-jejunal sleeve is based on a different concept, that of mimicking bariatric surgery; it effectively bypasses the duodenum and jejunum, and shows promising results. Other endoscopically implantable devices, such as the "Butterfly" and tubular membranes are at an experimental stage.

Miss rate for colorectal neoplastic polyps: a prospective multicenter study of back-to-back video colonoscopies.

BACKGROUND AND STUDY AIM: Polyp miss rates during colonoscopy have been calculated in a few tandem or back-to-back colonoscopy studies. Our objective was to assess the adenoma miss rate while limiting technique or operator expertise biases, i. e. by performing a large multicenter study, with same-day back-to-back video colonoscopy, done by two different operators in randomized order and blinded to the other examination. PATIENTS AND METHODS: 294 patients at 11 centers were included. Among the 286 analyzable tandem colonoscopies, miss rates were calculated in both a lesion- and patient-based analysis. Each of these rates was determined for polyps overall, for adenomas, and then for lesions larger than 5 mm, and for advanced adenomas. Univariate and logistic regression analysis were performed to define independent variables associated with missed polyps or adenomas. RESULTS: The miss rates for polyps, adenomas, polyps > or = 5 mm, adenomas > or = 5 mm, and advanced adenomas were, respectively, 28 %, 20 %, 12 %, 9 % and 11 %. None of the masses with a carcinomatous (n = 3) or carcinoid component (n = 1) was missed. The specific lesion miss rates for patients with polyps and adenomas were respectively 36 % and 26 % but the corresponding rates were 23 % and 9.4 % when calculated for all 286 patients. The diameter (1-mm increments) and number of polyps (> or = 3) were independently associated with a lower polyp miss rate, whereas sessile or flat shape and left location were significantly associated with a higher miss rate. Adequacy of cleansing, presence of diverticula, and duration of withdrawal for the first procedure were not associated with adenoma miss rate. CONCLUSIONS: We confirm a significant miss rate for polyps or adenoma during colonoscopy. Detection of flat polyps is an issue that must be focused on to improve the quality of colonoscopy.

The efficacy and safety of duodenal stenting: a prospective multicenter study.

BACKGROUND AND STUDY AIMS: Duodenal stenting has become a popular treatment in cases of malignant stenosis. However, a prospective evaluation of the efficacy and morbidity of this procedure has not been performed. A prospective multicenter study of duodenal stenting was conducted by the Société Française d'Endoscopie Digestive (SFED). PATIENTS AND METHODS: A total of 51 patients were selected (mean age 72), the majority (69%) having pancreatic adenocarcinoma. Palliative treatment was chosen because of irresectability (61.2%), inoperability (18.4%), or both (20.4 %). Enteral Wallstent prostheses were used, and the patients were followed up on day 3, after 1 month, and then every month, with weight measurement, and symptomatic and laboratory evaluation. RESULTS: One prosthesis was sufficient in 46 patients. Stent positioning and deployment were correct in 50/51 patients (98%). Twenty patients also underwent biliary stenting in addition to the duodenal stenting. On day 3, 43 patients (84%) were able to tolerate soft solids or a full diet. Six complications were attributed to stenting: three intestinal hemorrhages, two cases of peritonitis due to bowel perforation, and one case of septicemia, and these led to five deaths (mortality 9.8%). Stent dysfunction was observed in 12 cases (23.5%) after a mean delay of 75 days, comprising 11-malignant obstructions and one migration: a new stent was inserted inside the first one and was effective in eight cases; and no treatment was given in the other four patients because of their clinical state. The median survival was 71.5 days. CONCLUSIONS: Palliative endoscopic treatment of malignant duodenal stenosis using metallic prostheses is highly feasible, even with associated biliary stenting. Symptomatic improvement is fast. However, the mortality and the obstruction rate are high, suggesting that a prospective trial comparing this treatment with surgery is still required.

Similar performance but higher cholecystitis rate with covered biliary stents: results from a prospective multicenter evaluation.

BACKGROUND AND STUDY AIMS: Endoscopic biliary stenting is now a well-established treatment method in patients with unresectable malignant biliary obstruction. Despite advances with metal stents, the problem of stent occlusion has not yet been resolved. Covered metal stents could reduce the occlusion rate by preventing tumor ingrowth, but have not been well evaluated. A prospective multicenter study was therefore conducted to evaluate the efficacy and disadvantages of covered Wallstents. PATIENTS AND METHODS: Covered Wallstents were implanted endoscopically in 62 patients with inoperable distal malignant biliary obstruction. Complications, stent patency, and patient survival were analyzed. RESULTS: Stent insertion was achieved in 61 of the 62 patients (98.4 %). Procedure-related complications were observed in four patients, consisting of minor pancreatitis (n = 2) and abdominal pain due to stent expansion (n = 2). There was no procedure-related mortality. Seven patients died too early for proper assessment, so that a total of 54 patients were ultimately evaluated. Stent dysfunction occurred in 17 of the 54 patients (31.5 %). The reasons for dysfunction were proximal tumor overgrowth (n = 5), migration (n = 3), lithiasis or food impaction (n = 3), cholangitis without the need for a repeat biliary intervention (n = 5), and unknown (n = 1). The median period of stent patency was 142 days. No tumor ingrowth was observed. Acute cholecystitis was diagnosed in five patients (10 %) and was responsible for one death. Three stents were successfully removed. CONCLUSIONS: Covered biliary metal stents are effective for the drainage of distal malignant biliary obstruction, with a dysfunction rate apparently similar to that of uncovered stents. However, the risk of acute cholecystitis appears to be a major concern with this type of stent in patients with gallbladder in situ. Further comparative studies are needed.

[Ursodeoxycholic acid: prospect for treatment of gravidic cholestasis? Report of 3 cases]. / L'acide ursodésoxycholique: perspective de traitement de la cholestase gravidique? A propos de 3 observations.

Ursodeoxycholic acid, employed in treatment of intrahepatic cholestasis as seen in primary biliary cirrhosis, primary sclerosing cholangitis, and chronic hepatitis; does not have marketing approval for prescription during pregnancy because of lack of data. In 3 cases of gravidic cholestasis, we administered oral ursodeoxycholic acid 1 g a day from the 34th week of amenorrhea to delivery. In each case, it took 3 days of treatment for the pruritus to regress incompletely and for plasma levels of biliary acid and transaminases to decrease. The infants, born between the 36th and 38th week of amenorrhea, presented with no problem. Forty-eight cases of gravidic cholestasis treated by ursodeoxocholic acid (0.4 to 1 g a day) have been reported in the literature; 18 cases belonging to 2 randomized studies. In 46 cases pruritus disappeared generally 3 days after treatment onset, and plasma level of biliary acid and transaminase decreased in one week. Only two patients experienced persisting pruritus despite biological improvement. No foetal adverse effect is reported. Ursodeoxycholic acid seems to be an efficient treatment of gravidic cholestasis. Long term observation of fetuses exposed in utero to this treatment is required to assess safety.