Lawrence B Cohen

Endoscopic implantation of enteryx for treatment of GERD: 12-month results of a prospective, multicenter trial

OBJECTIVES:This study aimed to assess the efficacy and safety of endoscopically implanting a nonresorbable biocompatible polymer (Enteryx) in the distal esophagus and proximal gastric cardia for the treatment of gastroesophageal reflux disease (GERD).METHODS:In a prospective, multicenter, international trial, 85 well-controlled GERD patients who were receiving chronic proton pump inhibitor (PPI) therapy underwent Enteryx implantation under fluoroscopic visualization, without general anesthesia. After the procedure, patients were discharged within approximately 2–4 h. Patients were judged to be treatment responders if after implantation they reduced PPI dosage by ≥50%. Follow-up evaluations were conducted at 1, 3, 6, and 12 months and included medication usage, symptoms, quality of life, endoscopy, pH monitoring, manometry, and documentation of adverse events.RESULTS:At 12 months, 80.3% (95% CI = 69.9%–88.3%) of 81 evaluable patients were treatment responders. Of the responders, 87.7% completely discontinued PPIs, and 12.3% reduced PPI dosage by ≥50%. Treatment response was more likely in patients with residual implant volume of ≥5 mL (p = 0.027). Other patient and treatment variables were not predictive. Both GERD heartburn and regurgitation symptom scores significantly improved at 12 months compared with baseline (p < 0.001). There were significant reductions in median supine, upright, and total percent time of esophageal exposure to pH <4. Endoscopically assessed esophagitis grades were unchanged. No serious adverse events were encountered. Transient retrosternal chest pain was experienced by 91.8% of patients. This pain was seldom severe and was typically successfully managed with prescription pain medication.CONCLUSION:Enteryx implantation allows most patients to discontinue PPI therapy, improves their symptoms, and reduces esophageal acid exposure. The effects of implantation are long-lasting, and morbidity is transient and minimal. The procedure requires basic endoscopic skills and seems to provide a useful option in the effective clinical management of GERD.

A morphologic analysis of sessile serrated polyps observed during routine colonoscopy (with video)

BACKGROUNDnProximal colorectal cancer may arise from sessile serrated polyps (SSPs), which are often inconspicuous during colonoscopy. The gross morphologic characteristics of SSPs have not been systematically described, and this omission may contribute to colonoscopists overlooking them.nnnOBJECTIVESnTo analyze the gross morphologic characteristics of SSPs detected during routine colonoscopy.nnnDESIGNnRetrospective analysis of high-resolution endoscopic video clips depicting SSPs in situ.nnnSETTINGnOutpatient gastroenterology practice.nnnPATIENTSnA total of 124 subjects undergoing surveillance or screening colonoscopy after split-dose bowel preparation.nnnINTERVENTIONSnAnalysis of 158 SSPs performed by using validated descriptors.nnnMAIN OUTCOME MEASUREMENTSnThe prevalence of morphologic characteristics related to polyp shape, color, and texture.nnnRESULTSnA total of 158 SSPs were studied. For 7 visual descriptors, a κ coefficient of ≥ 0.7 was achieved, indicating good to excellent intraobserver agreement. The most prevalent visual descriptors were the presence of a mucous cap (63.9%), rim of debris or bubbles (51.9%), alteration of the contour of a fold (37.3%), and interruption of the underlying mucosal vascular pattern (32.3%). The most common sentinel signs were the presence of a mucous cap and alteration of the contour of a mucosal fold (each 24.6%), rim of debris or bubbles (21.7%), and a dome-shaped protuberance (20.3%). When comparing SSPs with adenomatous polyps, the frequencies of 5 of 7 morphologic characteristics and the distribution of sentinel signs differed (P < .01).nnnLIMITATIONSnSingle-site, retrospective analysis.nnnCONCLUSIONSnSSPs exhibit distinct, variable morphologic characteristics. Many do not display classic features such as a mucous cap. Enhanced appreciation of these morphologic characteristics may improve SSP detection and thereby colorectal cancer prevention.

Endoscopic, deep mural implantation of Enteryx for the treatment of GERD: 6-month follow-up of a multicenter trial.

OBJECTIVES:This prospective, multicenter, single-arm study evaluated the safety and efficacy of the endoscopic implantation of Enteryx, a biocompatible, non-biodegradable liquid polymer for the treatment of GERD.METHODS:Eighty-five patients with heartburn symptoms responsive to proton pump inhibitor (PPI) use were enrolled. Inclusion requirements were HRQL score ≤ 11 on PPI and ≥ 20 off PPI, and 24-hour PH probe with ≥ 5% total time at PH ≤ 4. Patients with a hiatus hernia > 3 cm, grade 3 or 4 esophagitis, or esophageal motility disorder were excluded. Using a 4-mm needle tipped catheter during standard endoscopy, implants were made in 3–4 quadrants deep into the wall of the cardia. Use of PPI medications, pH-metry, manometry, GERD symptoms, and patient quality of life were assessed over a 6-month follow-up period.RESULTS:At 6 months, PPI use was eliminated in 74% and reduced by > 50% in 10% of patients. The median HRQL score improved from 24.0 pre-implant (baseline off PPIs) to 4.0 at 6 months (p < 0.001). Mean total esophageal acid exposure time was 9.5% pretherapy and 6.7% at 6 months (p < 0.001). Mean LES length increased from 2.0 cm at baseline to 3.0 cm posttherapy (p = 0.003). There were no clinically serious adverse events. Transient mild-to-moderate chest pain commonly occurred after implantation.CONCLUSIONS:The endoscopic implantation of Enteryx is a safe and effective therapy for eliminating or decreasing the need for PPI medications, improving GERD symptoms and patient quality of life, and decreasing esophageal acid exposure among patients suffering from GERD.

The detection of premalignant colon polyps during colonoscopy is stable throughout the workday

BACKGROUNDnRecent studies have shown that colonoscopic polyp detection decreases as the workday progresses. This may reflect time-dependent factors such as colonoscopist fatigue and decreased colon cleanliness, which can be addressed through adaptations in colonoscopy practice.nnnOBJECTIVEnTo test for time-of-day differences in adenomatous polyp (AP) and sessile serrated polyp (SSP) detection in a practice that uses split-dose bowel preparation and moderated daily colonoscopist procedure loads.nnnDESIGNnRetrospective chart review.nnnSETTINGnCommunity-based, group gastroenterology practice.nnnPATIENTSnThis study involved 2439 patients undergoing surveillance or screening colonoscopy.nnnINTERVENTIONnColonoscopy.nnnMAIN OUTCOME MEASUREMENTSnDetection rate of all premalignant polyps (PMPs), and of APs and SSPs, individually.nnnRESULTSnA total of 1183 PMPs were identified in 1486 eligible patients (mean PMP/colonoscopy = 0.80; PMP detection rate = 47%). In univariate and multivariate analyses, PMP detection as well as detection of APs or SSPs individually did not vary significantly in relation to the hour of the day. In a binary comparison of morning (am) versus afternoon (pm) procedures, the total polyp detection rate was 67% and 66%, respectively. For PMPs, APs, SSPs, and hyperplastic polyps (HPs), the am and pm detection rates were 46% and 47%, 41% and 44%, 8% and 8%, and 27% and 24%, respectively. Bowel preparation quality was independent of time of day and was rated excellent or good in 86% to 87% of cases.nnnLIMITATIONSnRetrospective, nonrandomized study.nnnCONCLUSIONnStable PMP, AP, SSP, and HP detection rates throughout the workday occur under certain practice conditions, including the use of split-dose bowel preparation and/or moderated daily colonoscopist procedure loads.

Is production pressure jeopardizing the quality of colonoscopy? A survey of U.S. endoscopists' practices and perceptions.

BACKGROUNDnFatigue is an underestimated cause of underperformance among physicians. There is evidence that fatigue or other byproducts of production pressure may negatively influence the quality of colonoscopy.nnnOBJECTIVEnTo investigate the practices and perceptions of U.S. endoscopists regarding the effect of production pressure on the performance of colonoscopy.nnnDESIGNnWe conducted a 40-question online survey to assess endoscopists practices and perceptions concerning production pressure.nnnSETTINGnA total of 5030 U.S. American Society for Gastrointestinal Endoscopy members.nnnMAIN OUTCOME MEASUREMENTSnThe proportion of endoscopists responding positively to questions pertaining to the impact of production pressure on colonoscopy practice.nnnRESULTSnNinety-two percent of respondents indicated that production pressure influenced one or more aspects of their endoscopic practices. Examples of production pressure included (1) postponing polypectomy for a subsequent session (2.8%), (2) reducing the length of time spent inspecting the colon (7.2%), and (3) proceeding with colonoscopy in a patient with an unfavorable risk/benefit ratio (69.2%). Forty-eight percent of respondents reported witnessing the effects of production pressure on a colleague. Respondents working fee-for-service and those with >10 years since completion of fellowship were more likely to describe their weekly workloads as excessive compared with those who were salaried (81.3% vs 71.3%; P = .01) and <10 years out of training (81% vs 72.7%; P = .01).nnnLIMITATIONSnNonresponse bias due to low response rate (22.3%).nnnCONCLUSIONnProduction pressure influences the conduct of colonoscopy for many endoscopists and could have an adverse effect on the outcome of colorectal cancer screening. (nnnCLINICAL TRIAL REGISTRATION NUMBERnRE:GIE D 11-01288R1.) The study was an Internet study and did not involve human subjects.

A randomized, placebo‐controlled study of the effects of naproxen, aspirin, celecoxib or clopidogrel on gastroduodenal mucosal healing

Backgroundu2002 Many individuals with gastroduodenal ulcers require on‐going, non‐steroidal anti‐inflammatory drug (NSAID) or anti‐platelet therapy.

NSAID‐induced antral ulcers are associated with distinct changes in mucosal gene expression

Backgroundu2002 The basis for individual variation in gastroduodenal vulnerability to NSAIDs is not well understood.