David J. Desilets

Comparative performance of uncoated, self-expanding metal biliary stents of different designs in 2 diameters: final results of an international multicenter, randomized, controlled trial.

BACKGROUND The Wallstent has remained the industry standard for biliary self-expanding metal stents (SEMSs). Recently, stents of differing designs, compositions, and diameters have been developed. OBJECTIVE To compare the new nitinol 6-mm and 10-mm Zilver stents with the 10-mm stainless steel Wallstent and determine the mechanism of obstruction. DESIGN Randomized, prospective, controlled study. SETTING Nine centers experienced in SEMS placement during ERCP. PATIENTS A total of 241 patients presenting between September 2003 and December 2005 with unresectable malignant biliary strictures at least 2 cm distal to the bifurcation. MAIN OUTCOME MEASUREMENT Stent occlusions requiring reintervention and death. RESULTS At interim analysis, a significant increase in occlusions was noted in the 6-mm Zilver group at the P = .04 level, resulting in arm closure but continued follow-up. Final study arms were 64, 88, and 89 patients receiving a 6-mm Zilver, 10-mm Zilver, and 10-mm Wallstent, respectively. Stent occlusions occurred in 25 (39.1%) of the patients in the 6-mm Zilver arm, 21 (23.9%) of the patients in the 10-mm Zilver arm, and 19 (21.4%) of the patients in the 10-mm Wallstent arm (P = .02). The mean number of days of stent patency were 142.9, 185.8, and 186.7, respectively (P = .057). No differences were noted in secondary endpoints, and the study was ended at the 95% censored study endpoints. Biopsy specimens of ingrowth occlusive tissue revealed that 56% were caused by benign epithelial hyperplasia. CONCLUSIONS SEMS occlusions were much more frequent with a 6-mm diameter SEMS and equivalent in the two 10-mm arms despite major differences in stent design, material, and expansion, suggesting that diameter is the critical feature. Malignant tumor ingrowth produced only a minority of the documented occlusions.

Per-oral endoscopic myotomy white paper summary.

Achalasia is an uncommon esophageal motility disorder in which there is selective loss of inhibitory neurons resulting in loss of peristalsis and failure of adequate relaxation of the lower esophageal sphincter (LES) in response to food bolus. There is no current curative treatment that reverses the pathophysiology of achalasia. The treatment options are aimed at improving the passage of solids and liquids through the gastroesophageal junction (GEJ). The traditional treatment options include surgical myotomy and endoscopic methods that disrupt or weaken the LES, such as endoscopic balloon dilation and botulinum toxin injection (BI). Per-Oral Endoscopic Myotomy (POEM) represents a Natural Orifice Translumenal Endoscopic Surgery (NOTES ) approach to Heller myotomy. Preliminary data suggest that this minimally invasive endoscopic procedure may achieve clinical results similar to those of surgical myotomy. As part of the annual Natural Orifice Surgery Consortium for Assessment and Research (NOSCAR ) meeting held in Chicago in July 2012, a conference was organized to collaboratively review POEM and develop a consensus document on the current status of POEM. An International POEM Survey (IPOEMS) was designed and conducted by the session moderators as part of this NOSCAR initiative to attempt to supplement the scant published literature with current data from POEM early adopters. The survey, which has now been published in This article is being published simultaneously in both Gastrointestinal Endoscopy and Surgical Endoscopy.

Multicenter randomized trial of the spiral Z-stent compared with the Wallstent for malignant biliary obstruction.

BACKGROUND The industry standard since 1990 for self-expanding biliary metallic stents has been the Wallstent. In 1998 the Spiral Z-stent was released. This randomized trial compared the Z-stent with the Wallstent in the treatment of malignant biliary obstruction. METHODS Patients with unresectable malignant biliary obstruction distal to the bile duct bifurcation were randomized to receive a 10-mm diameter Wallstent or a 10-mm diameter Z-stent. RESULTS A total of 145 patients were randomized; 13 were excluded. Sixty-four patients who received a Z-stent and 68 who had a Wallstent are included in the analysis. Tumors responsible for bile duct obstruction were pancreatic cancer (108), cholangiocarcinoma (15), metastatic cancer (6), and papillary cancer (3). Metallic stents were successfully placed in all patients. Seven technical problems were encountered during placement of the Z-stent and 5 with the Wallstent. There were 21 occlusions requiring reintervention (8 Z-stent, 13 Wallstent; p = 0.30). Median time to reintervention was the following: Z-stent, 162 days; Wallstent, 150 days (p = 0.22). A total of 104 patients died of progressive disease or other cause; 7 patients remain alive with patent stents. The overall calculated median patency rates were: Z-stent, 152 days; Wallstent, 154 days (p = 0.90). CONCLUSIONS The Spiral Z-stent is comparable with the Wallstent in terms of placement, occlusion rates, and overall patency. Occasional early occlusion of both stents suggests tumor characteristics instead of the size of the mesh openings in the stents as important factors.

Equipment for pediatric endoscopy.

d f o 2 u t b f p t The American Society for Gastrointestinal Endoscopy (ASGE) Technology Committee provides reviews of existing, new, or emerging endoscopic technologies that have an impact on the practice of GI endoscopy. Evidencebased methodology is used by performing a MEDLINE literature search to identify pertinent clinical studies on the topic and a MAUDE (U.S. Food and Drug Administration Center for Devices and Radiological Health) database search to identify the reported complications of a given technology. Both are supplemented by accessing the “related articles” feature of PubMed and by scrutinizing pertinent references cited by the identified studies. Controlled clinical trials are emphasized, but in many cases, data from randomized, controlled trials are lacking. In such cases, large case series, preliminary clinical studies, and expert opinions are used. Technical data are gathered from traditional and Web-based publications, proprietary publications, and informal communications with pertinent vendors. Technology Status Evaluation Reports are drafted by 1 or 2 members of the ASGE Technology Committee, reviewed and edited by the committee as a whole, and approved by the governing board of the ASGE. When financial guidance is indicated, the most recent coding data and list prices at the time of publication are provided. For this review, the MEDLINE database was searched through June 2011 for articles related to endoscopy in pediatric patients by using the key words pediatric, children, infants, endoscopy, colonoscopy, gastrointestinal bleeding, single balloon enteroscopy, double balloon enteroscopy, capsule endoscopy, biopsy, esophageal strictures, dilation, endoscopic ultrasound, and ERCP. Technology Status Evaluation Reports are scientific reviews provided solely for educational and informational purposes. Technology Status Evaluation Reports are not rules and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment or payment for such treatment.

Effect of an educational pamphlet on colon cancer screening: A randomized, prospective trial

Introduction Anxious patients can cause unexpected increases in healthcare costs that are often overlooked. There are no studies examining the use of an educational pamphlet and its effects on secondary outcomes at colonoscopy. The goal of this study was to determine if the use of an educational pamphlet lowers the anxiety levels before colonoscopy, and if its use has any effect on the quality of the prep or medication or the amount of medication use during the procedure. Methods We prospectively enrolled 121 patients having a first-time screening colonoscopy. Patients were blinded and randomized into two groups. One group received standard prep instructions only (group P), and the other group received the American Gastroenterological Association colonoscopy educational pamphlet along with their prep instructions (group I). All information was sent by mail 3 weeks before the procedure. The endoscopists were blinded as to which of their patients were in the study and of those, which were in the standard prep group or the intervention group. Anxiety was measured immediately before endoscopy using the State portion of the ‘State Trait Anxiety Index’. Procedure-related information was recorded and analyzed at the end of the study using a statistical package looking at primary and secondary endpoints. Results Fifteen patients did not show their examination or were otherwise lost to follow-up. Of the 106 patients who completed the study, there were 55 patients in the P group and 51 in the I group. The average State Anxiety score of the P group was 45.18, and of the I group was 40.54 (P=0.014). The use of Midazolam was significantly less in the group. The use of Meperidine was lower in the I group but the difference was not statistically significant. Both the groups took the same amount of time to complete the prep, but the I group fasted longer. The I group also completed or drank more of the prep more often than the P group. The prep quality was found to be superior with less frequency of a poor prep in the I group. Most important, the I group was more likely to have a complete colonoscopy. The I group tended to have fewer questions on the day of the procedure, and less fear about what to expect on the basis of their lower anxiety scores. Conclusion We found that providing the American Gastroenterological Association educational pamphlet to patients before colonoscopy lowers the overall anxiety level, provides a reduction in sedative use during the procedure, and leads to better colon preparation when given in addition to standard instructions.

Cholestatic jaundice associated with the use of metformin

We report a patient who developed cholestatic jaundice shortly after initiation of treatment with metformin hydrochloride. Ultrasound of the liver and abdominal CT were normal. An ERCP showed normal biliary anatomy. A percutaneous liver biopsy was obtained showing marked cholestasis, with portal edema, ductular proliferation, and acute inflammation. Metformin hydrochloride was discontinued, and the patients jaundice resolved slowly over a period of several months. Given the onset of his jaundice 2 wk after the initiation of metformin, we believe that this case represents an example of metformin-associated hepatotoxicity, the first such case reported.

Methods of luminal distention for colonoscopy

w e r i n t a d The ASGE Technology Committee provides reviews of existing, new, or emerging endoscopic technologies that have an impact on the practice of GI endoscopy. Evidencebased methodology is used, performing a MEDLINE literature search to identify pertinent clinical studies on the topic and a MAUDE (U.S. Food and Drug Administration Center for Devices and Radiological Health) database search to identify the reported adverse events of a given technology. Both are supplemented by accessing the “related articles” feature of PubMed and by scrutinizing pertinent references cited by the identified studies. Controlled clinical trials are emphasized, but in many cases, data from randomized, controlled trials are lacking. In such cases, large case series, preliminary clinical studies, and expert opinions are used. Technical data are gathered from traditional and Web-based publications, proprietary publications, and informal communications with pertinent vendors. Technology Status Evaluation Reports are drafted by 1 or 2 members of the ASGE Technology Committee, reviewed and edited by the Committee as a whole, and approved by the Governing Board of the ASGE. When financial guidance is indicated, the most recent coding data and list prices at the time of publication are provided. For this review, the MEDLINE database was searched through February 2012 for relevant articles by using the key words “colonoscopy,” “insufflation,” “air,” “carbon dioxide,” and “water.” Technology Status Evaluation Reports are scientific reviews provided solely for educational and informational purposes. Technology Status Evaluation Reports are not rules and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment or payment for such treatment.

Emerging technologies for endoscopic hemostasis

e s o P s m p a o p d a a o The American Society for Gastrointestinal Endoscopy (ASGE) Technology Committee provides reviews of emerging endoscopic technologies that have the potential to affect the practice of GI endoscopy. Evidence-based methodology is used, with MEDLINE and PubMed literature searches to identify pertinent clinical studies on the topic. Because many topics have a limited number of peerreviewed articles, abstracts from scientific meetings are used to supplement the review. The reports focus on the current status of the technologies, areas in need of further research, and barriers to incorporation into the mainstream practice of GI endoscopy. Reports on Emerging Technologies are drafted by 1 or 2 members of the ASGE Technology Committee, reviewed and edited by the committee as a whole, and approved by the Governing Board of the ASGE. These reports are scientific reviews provided solely for educational and informational purposes. Reports on Emerging Technologies are not rules and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment or payment for such treatment.

Endoscopic interventions for weight loss surgery

In this paper we review the state‐of‐the‐art in endoscopic interventions for obesity treatment and make best practice recommendations for weight loss surgery (WLS). We performed a systematic search of English‐language literature published between April 2004 and June 2008 in MEDLINE and the Cochrane Library on WLS and endoscopic interventions, endoscopically placed devices, minimally invasive surgery, image‐guided surgery, endoluminal surgery, endoscopic instrumentation, interventional gastroenterology, transluminal surgery, and natural orifice transluminal surgery. We also searched the literature on endoscopic interventions and WLS and patient safety. We identified 36 pertinent articles, all of which were reviewed in detail; assessed the current science in endoscopic interventions for WLS; and made best practice recommendations based on the latest available evidence. Our findings indicate that endoscopic interventions and endoscopically placed devices may provide valuable approaches to the management of WLS complications and the primary management of obesity. Given the rapid changes in endoscopic technologies and techniques, systematic literature review is required to address issues related to the emerging role of endoluminal surgery in the treatment of obesity. These interventions should be a high priority for development and investigation.

Esophageal Function Testing

Esophageal functional testing comprises assessments of esophageal motility and reflux, for the diagnosis of esophageal motility disorders and acid and nonacid reflux in gastroesophageal reflux disease (GERD). Testing is accomplished using a catheter-based esophageal manometry system, as well as catheter-based and capsule-based pH and impedance systems.