Transanal endoscopic microsurgery is feasible for adenomas throughout the entire rectum: a prospective study.

INTRODUCTION: Transanal endoscopic microsurgery for rectal adenomas is safe and has low recurrence rates. However, the feasibility of the procedure for all rectal adenomas is unclear. This issue was investigated prospectively. METHODS: From 1996 to 2007, 353 consecutive rectal adenomas were evaluated according to a standard protocol. Transanal endoscopic microsurgery was intended in all rectal adenomas. RESULTS: The median diameter was 3 cm and median distance was 8 cm. The peritoneum was opened peroperatively without any adverse effects in 8.7 percent. The conversion rate was 9.6 percent, with an alternative local procedure performed in 4.2 percent and a transabdominal procedure performed in 5.4 percent. Conversion rate correlated with the distance of the tumor (P = 0.007) and the operating surgeon's level of experience (P = 0.004). The median operation time was 45 minutes. Operation time correlated with specimen area, experience, and operating surgeon (all P < 0.001). All rectal adenomas were excised in one piece. Complete margins were observed in 85 percent. Rectal adenomas with incomplete margins were larger (P < 0.001) and were located more proximally (P < 0.001). Morbidity was 7.8 percent and mortality 0.6 percent. The median hospital stay was four days. The median follow-up was 27 months. The recurrence rate at three years was 9.1 percent. The median time from operation to recurrence was 12 (range, 4-54) months. Resection margin status was a predictor of recurrence, with 6.1 percent recurrence in cases of complete margins and 25.2 percent in cases of incomplete margins (P < 0.001). CONCLUSIONS: For nearly all rectal adenomas, transanal endoscopic microsurgery is safe, feasible, and has excellent results.

Transanal endoscopic microsurgery versus endoscopic mucosal resection for large rectal adenomas (TREND-study).

BACKGROUND: Recent non-randomized studies suggest that extended endoscopic mucosal resection (EMR) is equally effective in removing large rectal adenomas as transanal endoscopic microsurgery (TEM). If equally effective, EMR might be a more cost-effective approach as this strategy does not require expensive equipment, general anesthesia and hospital admission. Furthermore, EMR appears to be associated with fewer complications.The aim of this study is to compare the cost-effectiveness and cost-utility of TEM and EMR for the resection of large rectal adenomas. METHODS/DESIGN: Multicenter randomized trial among 15 hospitals in the Netherlands. Patients with a rectal adenoma > or = 3 cm, located between 1-15 cm ab ano, will be randomized to a TEM- or EMR-treatment strategy. For TEM, patients will be treated under general anesthesia, adenomas will be dissected en-bloc by a full-thickness excision, and patients will be admitted to the hospital. For EMR, no or conscious sedation is used, lesions will be resected through the submucosal plane in a piecemeal fashion, and patients will be discharged from the hospital. Residual adenoma that is visible during the first surveillance endoscopy at 3 months will be removed endoscopically in both treatment strategies and is considered as part of the primary treatment. Primary outcome measure is the proportion of patients with recurrence after 3 months. Secondary outcome measures are: 2) number of days not spent in hospital from initial treatment until 2 years afterwards; 3) major and minor morbidity; 4) disease specific and general quality of life; 5) anorectal function; 6) health care utilization and costs. A cost-effectiveness and cost-utility analysis of EMR against TEM for large rectal adenomas will be performed from a societal perspective with respectively the costs per recurrence free patient and the cost per quality adjusted life year as outcome measures. Based on comparable recurrence rates for TEM and EMR of 3.3% and considering an upper-limit of 10% for EMR to be non-inferior (beta-error 0.2 and one-sided alpha-error 0.05), 89 patients are needed per group. DISCUSSION: The TREND study is the first randomized trial evaluating whether TEM or EMR is more cost-effective for the treatment of large rectal adenomas. TRIAL REGISTRATION NUMBER: (trialregister.nl) NTR1422.

Capsule endoscopy for the detection of oesophageal mucosal disorders: a comparison of two different ingestion protocols.

OBJECTIVE: To assess the accuracy of a new ingestion protocol for capsule endoscopy (CE) in evaluating patients with gastro-oesophageal reflux disease (GORD). METHODS: Oesophago-gastroduodenoscopy (OGD) was performed 1 week prior to CE. The first 28 subjects swallowed the capsule following the original ingestion protocol (OIP) and the subsequent 30 subjects following a simplified ingestion protocol (SIP). CE videos were reviewed by two independent investigators who were blinded to the OGD findings. RESULTS: Of 48 patients included, 24 were diagnosed with reflux oesophagitis (67% male, mean age 49.5+/-13 years) and 24 with Barrett oesophagus (BO) (88% male, 55.6+/-10 years) by OGD. In addition, 10 asymptomatic healthy controls (50% male, 45.8+/-7.1 years) were included. Oesophageal transit time was faster in patients using the SIP compared to the OIP (126+/-26 s versus 214+/-33; p=0.04). Complete evaluation of the Z-line was possible in 19/28 (68%) of the OIPs compared to 28/30 (93%) of the SIPs (p=0.04). Sensitivity for detecting any oesophageal abnormality was higher in the SIP group than in the OIP group (97% versus 89%; p=0.11). Overall, CE detected oesophagitis in 22/24 patients (sensitivity, 92%; specificity, 88%) and BO in 23/24 patients (sensitivity, 96%; specificity, 91%). Furthermore, 41/44 (93%) preferred CE over OGD and experienced less discomfort and pain during CE. CONCLUSION: CE is an accurate method for detecting mucosal oesophageal abnormalities. The new ingestion protocol improves the visualization of the Z-line, which is likely to increase the diagnostic yield of CE.

Multicenter study evaluating factors for stent patency in patients with malignant biliary strictures: development of a simple score model.

BACKGROUND: Self-expanding metal stents (SEMS) are known to have a significantly higher patency rate than plastic stents. We aimed to identify prognostic factors, besides stent type, for stent patency and to develop a score model that could further aid in guiding stent choice for the palliation of a malignant biliary stricture. METHODS: A retrospective multicenter study was conducted. Data on consecutive patients who had a stent placed between January 2002 and July 2009 were collected. Cumulative stent occlusion rates were analyzed by Kaplan-Meier curves and log rank testing, and prognostic factors were assessed by Cox regression analysis. RESULTS: A total of 690 stents (512 plastic stents, 174 SEMS) were endoscopically placed in 390 patients. At 8 weeks, stent occlusion had occurred in 32% of the plastic stents and 11% of the SEMS. Multivariate analysis indicated that plastic stents (hazard ratio [HR] 2.5, 95% confidence interval [CI] 1.9-3.5), a tight stricture requiring preceding dilation (HR 1.8, 95% CI 1.3-2.5), and a high initial bilirubin level (>50 µmol/L (HR 1.3, 95% CI 1.0-1.7) were independently associated with an increased risk of stent occlusion. A score model based on these 3 factors was able to distinguish between stent procedures with a relatively high and low risk of stent occlusion (median 14 vs. 26 weeks, respectively). CONCLUSION: Besides plastic stents, stricture severity requiring preceding dilation, and initial higher bilirubin level were associated with a shorter period of stent patency. A simple score model based on these factors was able to predict stent occlusion and may aid in choosing the most appropriate stent type in individual patients.

COX-2 CA-haplotype is a risk factor for the development of esophageal adenocarcinoma.

BACKGROUND: Neoplastic progression of BE towards EAC is associated with increased expression of COX-2. Increased COX-2 expression and enzyme activity is linked to the COX-2 CA haplotype, which consists of two gene polymorphisms in the COX-2 promoter. AIM: To study the impact of COX-2 haplotypes on the risk of developing EAC in patients with different forms of gastroesophageal reflux disease including BE. METHODS: DNA was obtained from a total of 635 Dutch white patients comprised of 140 patients with EAC, 255 with BE, and 240 with reflux esophagitis. COX-2 haplotypes were based on the gene polymorphisms at -765C/G and -1195A/G, as determined by PCR-RFLP. RESULTS: The tested population contained 170 (14%) CA- (-765C and -1195A) haplotypes, 829 (65%) GA and 271 (21%) GG-haplotypes, and no GC-haplotypes. The haplotype distribution in patients with reflux esophagitis and BE was similar (CA 12%, GA 68%, GG 21%), but differed significantly from that in patients with EAC (CA 21%, GA 58%, GG 20%). Particularly, the CA-haplotype was more common (P < 0.001) in EAC patients. CA-carriership was associated with EAC (OR 2.8, 95% CI 1.3-6.2, P= 0.008), with homozygosity for the CA-allele being statistically most significantly associated (OR 6.1, 95% CI 1.6-24.2, P= 0.01). CONCLUSION: The COX-2 CA-haplotype is more frequently observed in patients with EAC than in patients with BE and reflux esophagitis. These data suggest a direct link between COX-2 activity and neoplastic progression in patients with BE and reflux esophagitis.

Does Helicobacter pylori infection influence response rate or speed of symptom control in patients with gastroesophageal reflux disease treated with rabeprazole?

OBJECTIVE: The findings of several studies suggest that proton-pump inhibitors (PPIs) suppress gastric acid more effectively in Helicobacter pylori-infected (Hp +) than in non-infected (Hp -) patients, but there has been no evaluation of the short-term clinical response. MATERIAL AND METHODS: Results of the first week of treatment with rabeprazole in Hp+ and Hp- patients with gastroesophageal reflux disease (GERD) were compared in a large prospective open-label, multicenter, cohort study in general and specialized practices. GERD patients were recruited on the basis of either typical symptoms alone or endoscopic results, assessed for H. pylori infection and treated with rabeprazole (20 mg). Heartburn and regurgitation symptoms were assessed daily during the first 7 days. Outcome parameters were calculated for both symptoms and compared between Hp+ and Hp- patients. RESULTS: Data on 1548 patients (74.5% Hp-, 25.5% Hp + ) were available. Mean heartburn and regurgitation scores decreased during the first week. For both symptoms, more than 70% of the patients had "adequate" symptom relief at day 5, and more than 80% at day 7. "Complete" symptom relief was reached in more than 70% of patients. Mean onset of adequate symptom control was about 4 days. In Hp+ and Hp- patients there was no difference in response for any of the parameters. CONCLUSIONS: Among patients treated with rabeprazole in clinical practice, H. pylori infection or its absence has no effect on the speed or degree of GERD symptom relief. Infected patients and non-infected patients can therefore be treated with a similar dose. When treating heartburn with rabeprazole, physicians do not need to consider the patient's H. pylori status and most patients (>80%) have adequate symptom relief after just a few days of treatment.