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.

A rare case of mantle cell lymphoma as lymphomatous polyposis with widespread involvement of the digestive tract.

Lymphomatous polyposis of the gastrointestinal tract is rare. It refers to a heterogeneous group of small B-cell lymphomas including mantle cell lymphoma, follicular lymphoma and MALT lymphoma. It is characterized by the presence of multiple lymphomatous polyps along one or more segments of the digestive tract. Clinical symptoms are non-specific. We herein report the case of a 74-year old man initially admitted for an upper and lower gastrointestinal endoscopy to explore a positive Hemoccult test. The endoscopy revealed multiple polyps all along the gastrointestinal tract. Histopathological study showed a diffuse lymphomatous proliferation of small B-cells whose immunohistochemical features were compatible with a mantle cell lymphoma. Tumoral B-cells showed a positivity of cyclin D1 markers but negativity for CD5. Immunochemotherapy with R-CHOP (rituximab, cyclophosphamide, adriamycine, vincristine and prednisone) was initiated. Based on this case study, the pitfalls of gastrointestinal tract lymphomatous polyposis diagnosis, prognosis and treatment options are discussed.

Intravenous nitroglycerin for prevention of pancreatitis after therapeutic endoscopic retrograde cholangiography: a randomized, double-blind, placebo-controlled multicenter trial.

BACKGROUND AND STUDY AIMS: Several studies have suggested that nitroglycerin promotes pancreatic drainage and thereby helps to prevent pancreatitis occurring after endoscopic retrograde cholangiography (ERC). We performed a multicenter, double-blind, randomized, placebo-controlled trial to evaluate the efficacy of intravenous nitroglycerin for preventing acute pancreatitis in moderate- to high-risk patients undergoing ERC. PATIENTS AND METHODS: The patients underwent therapeutic ERC for gallstone removal, bile duct stenosis, or sphincter of Oddi dysfunction (SOD). They were randomly allocated to receive an intravenous nitroglycerin bolus of 0.1 mg, then 35 microg/kg per minute intravenously (maximum dose 9 mg) for 6 h, or an identical placebo regimen. Serum amylase and lipase levels were determined before and 24 h after ERC. RESULTS: The study was terminated after the interim analysis. The intention-to-treat population consisted of 208 patients enrolled in 20 centers, of whom 105 received nitroglycerin and 103 placebo therapy. Post-ERC pancreatitis (mild/moderate/severe) occurred in 25 patients, comprising 10 (3/5/2) in the nitroglycerin arm and 15 (5/6/4) in the placebo arm (OR 0.62, 95 % CI 0.26 - 1.45; P = 0.26). Pancreatitis-related hospital stays were similar in the two groups (median 4 days, range 2 - 13 days in the nitroglycerin group; median 5 days, range 2 - 20 days in the placebo group). The incidence of pancreatitis in patients with SOD did not differ between the groups (4/11 in the nitroglycerin arm, and 4/15 in the placebo arm). Adverse events were more frequent in the nitroglycerin group and led to cessation of drug infusion in 10 patients in the nitroglycerin arm and in 2 patients in the placebo arm ( P = 0.019). CONCLUSION: In this study, nitroglycerin offered a limited and clinically nonsignificant benefit for the prevention of post-ERC pancreatitis. Its use did not improve the technical success rate of ERC.

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.

Endoscopic screening for esophageal squamous-cell carcinoma in high-risk patients: a prospective study conducted in 62 French endoscopy centers.

BACKGROUND AND STUDY AIMS: The prevalence of esophageal squamous-cell carcinoma in high-risk patients and the advantages of systematic Lugol staining during esophagoscopy have not yet been evaluated in a large prospective study. In this study we aimed to assess the prevalence of this type of tumor in high-risk patients, to examine the role of Lugol staining in endoscopic screening for esophageal squamous-cell carcinoma, and to establish whether it is possible to identify a particularly high-risk group which would benefit from systematic screening. PATIENTS AND METHODS: A prospective study was undertaken in 62 endoscopy centers. A total of 1095 patients were enrolled, none of whom had any esophageal symptoms. These patients had presented with either a past history of or a recent head and neck or tracheobronchial squamous-cell carcinoma (group 1), with alcoholic chronic pancreatitis (group 2), with alcoholic cirrhosis (group 3), or were alcohol and tobacco addicts (group 4). The patients underwent a meticulous endoscopic examination of the esophagus, followed by Lugol staining. RESULTS: The prevalence of esophageal squamous-cell carcinoma was 3.2 %. The group 1 patients showed the highest prevalence of carcinoma (5.3 %) and the highest prevalence of dysplasia (4.5 %). Of the 35 carcinomas detected in the 1095 patients, seven (20 %) were early lesions, and 20 % were only detected after Lugol staining (P = 0.02). High-grade dysplasia was only observed in group 1 patients and two-thirds of these lesions were only diagnosed after Lugol staining. The overall prevalence of low-grade dysplasia was 2.4 %, and 77 % of these were detected only after Lugol staining (P < 0.001). CONCLUSIONS: Lugol dye staining increases the sensitivity of esophageal endoscopy for the detection of high-grade dysplasia and cancer. The prevalence of dysplasia and cancer reached 9.9 % in group 1, and we therefore believe that an endoscopic screening program could be justified for patients with head and neck or tracheobronchial cancer.

Effects of octreotide on lower esophageal sphincter in patients with cirrhosis and portal hypertension.

We investigated the effects of octreotide infusion on the contractile activity of the esophageal body and lower esophageal sphincter in cirrhotic patients with esophageal varices. Esophageal manometry was performed in 36 alcoholic cirrhotic patients. They were randomly allocated to three groups and received the following treatments blindly for 90 min: an initial 100-microg intravenous bolus followed by a continuous 25 microg/hr octreotide infusion (group I, N= 13), a continuous 25 micro/hr octreotide infusion without an initial bolus (group II, N=13), and a continuous placebo infusion (group III, N=10). Before drug infusion, mean lower esophageal sphincter pressure and mean esophageal body contraction pressure and duration were similar in the three groups. Compared to the placebo group, lower esophageal sphincter pressure increased significantly in groups I and II, 30 min (30%, 22%, 3% respectively; P= 0.006), 60 min (44%, 35%, 0.6%; P=0.0002), and 90 min (67%, 41%, 2.5%; P=0.0001) after octreotide infusion, as did esophageal body contraction pressure and duration. We conclude that octreotide has a potent effect on LES tone in cirrhotic patients.

Non-steroidal anti-inflammatory drugs and variceal bleeding: a case-control study.

BACKGROUND/AIM: The aim of this case-control study was to assess the risk of bleeding from esophageal varices associated with aspirin and non-steroidal anti-inflammatory drug consumption. METHODS: Between January 1992 and May 1994, patients admitted for bleeding from esophageal or gastric lesions related to portal hypertension were matched with a control patient of the same age and sex, who was free of gastrointestinal bleeding. A structured interview was conducted with the cases and controls to determine drug consumption during the 2 weeks preceding admission. Fifty-nine cases and 59 controls were recruited. RESULTS/CONCLUSIONS: Use of aspirin was more prevalent among the cases than the controls (odds ratio 3.81; 95% confidence interval 1.36-11.64; p = 0.004). This difference remained significant in the subgroups of patients with a first episode of variceal bleeding (odds ratio 3.9; 95% confidence interval 1.2-13.9, p = 0.01), but was not significant in the subgroups of patients with a recurrent episode of variceal bleeding. The use of aspirin was associated with a high risk of a first episode of variceal bleeding, suggesting that patients with portal hypertension should avoid taking these drugs.

Randomised trial of prevention of biliary stent occlusion by ursodeoxycholic acid plus norfloxacin.

Biliary stents are liable to clog. We investigated whether a choleretic plus an antibiotic could delay clogging. 20 consecutive patients with a malignant biliary stricture were randomised after endoscopic insertion of a polyethylene stent to receive ursodeoxycholic acid plus norfloxacin (13-15 mg/kg and 400 mg, daily) or conservative treatment. The drug combination was associated with: a longer median patency of first (49 vs 6 weeks) and all stents (38 vs 7 weeks); a prolonged median survival (67 vs 18 weeks); and a shorter mean hospital stay (0.2 vs 1.0 days per week of survival). Thus ursodeoxycholic acid plus norfloxacin may prevent stent clogging.

[Total parenteral nutrition-related cholestatic hepatopathy, is it an infectious disease?]. / L'hépatopathie cholestatique de la nutrition parentérale totale est-elle une maladie infectieuse?

The aim of this retrospective study was to determine whether total parenteral nutrition-related liver disease was improved by intravenous antibiotics given for systemic sepsis. Liver function tests were performed 1 month before, during and 1 month after one episode of sepsis treated for 4 weeks (mean, range: 2-12), with systemic antibiotics, in 12 patients receiving parenteral nutrition for 13 months (mean, range: 1-71) for short bowel syndrome in 10 of them. Cholestatic liver disease appeared in all during nutrition (mean serum alkaline phosphatase activity > 4 N). Liver test abnormalities observed at the beginning of antibiotics treatment were not significantly different from those observed 1 month before sepsis. Antibiotic administration was followed by a significant decrease (P < or = 0.03) in serum activities of alkaline phosphatases, ALT and AST and bilirubinemia of 38, 41, 23 and 47%, respectively. These results support the concept that parenteral nutrition-associated cholestatic liver disease may be related to intestinal bacterial overgrowth and suggest that it may be improved by intravenous antibiotherapy.

Treatment and long-term outcome of chronic radiation esophagitis after radiation therapy for head and neck tumors. A report of 13 cases.

The natural history of chronic radiation esophagitis occurring in previously normal esophagus is still unknown. We describe here the long-term outcome of chronic esophagitis arising after neck irradiation for oropharynx and larynx carcinomas in 13 consecutive adult patients. The first clinical signs of radiation esophagitis were dysphagia or impossibility of oral intake, which appeared within 26 months (range 2-120 months) after the end of radiation for pyriform fossae carcinoma (N = 5), tonsil carcinoma (N = 2), larynx carcinoma (N = 2), pharynx carcinoma (N = 2), base of the tongue (N = 1), and thyroid carcinomas (N = 1). During upper endoscopy, an esophageal stenosis was found in 11 cases and was associated with ulceration in three cases. An isolated esophageal ulceration was present in only two cases. Chronic radiation esophagitis diagnosis was confirmed by histology and surgery in seven cases. In the last six cases, diagnosis was supported by the absence of first cancer relapses within a median follow-up of two years (16 months to nine years) and by endoscopic findings. Seven patients received parenteral or enteral nutrition. Ten patients were treated by peroral dilatations. These treatments allowed nearly normal oral diet in 11/13 patients. Only one patient was lost of follow-up after 20 months. Four patients died from chronic radiation esophagitis. One of these patients died from massive hemorrhage after peroral dilatation. Four patients died of a second carcinoma with no first cancer recurrence. Four patients were alive after six months to nine years of follow-up. Moderate dysphagia was still present, allowing nearly normal oral feeding.(ABSTRACT TRUNCATED AT 250 WORDS)