Faculty Bibliography

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 < or = 11 on PPI and > or = 20 off PPI, and 24-hour PH probe with > or = 5% total time at PH < or = 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.

BACKGROUND: "Sphincterotomy stenosis" is a recognized late complication of endoscopic biliary sphincterotomy. The narrowing is limited to the biliary orifice and can be managed simply by repeat sphincterotomy. A similar but poorly characterized post-sphincterotomy complication involves narrowing that extends from the biliary orifice for a variable distance along the bile duct, beyond the duodenal wall. This lesion cannot be managed by repeating the sphincterotomy. METHODS: Six patients (3 men) are described with sphincterotomy associated biliary strictures, all smooth and high grade, presenting at a median of 19 months (range 8 to 60 months) after sphincterotomy. Further sphincterotomy was not possible as an intra-duodenal segment of bile duct was no longer visible. Endoscopic management consisted of serial incremental stent exchange at 2- to 4-month intervals. The goal of therapy was to place two 11.5F stents side-by-side. RESULTS: Stricture resolution was documented by cholangiography in all patients. One patient with a stricture resistant to treatment required three 10F stents side-by-side, and another underwent treatment to a maximum of adjacent 11.5F and 7F stents. Two 11.5F stents were eventually placed in the other four patients. Overall median duration of stent placement was 12.5 months. At a median of 26.5 months of stent-free follow-up, all patients remain asymptomatic. CONCLUSION: Sphincterotomy-associated biliary strictures are a distinct late complication of biliary sphincterotomy. These recalcitrant lesions are not amenable to repeat sphincterotomy; however, the results of this study suggest that they may be managed successfully by serial placement of stents of incrementally increasing diameter.

BACKGROUND: Droperidol has been used in combination with narcotics and benzodiazepines to achieve conscious sedation. We performed a randomized, double-blind, study of droperidol in patients at risk for difficult sedation scheduled for therapeutic endoscopy. METHODS: Patients with regular ethanol, narcotic, or benzodiazepine usage, suspected sphincter of Oddi dysfunction, or a history of difficult sedation were eligible for the study. Patients were randomized to receive either droperidol or placebo along with midazolam and meperidine as preprocedure sedation. Time to achieve sedation, interruptions due to undersedation, medication dosages, recovery time, and subjective assessments of sedation were recorded. RESULTS: One hundred one patients were randomized. The droperidol group had significantly fewer procedure interruptions and observer ratings of difficulty with sedation and required significantly less midazolam (23%) and meperidine (16%) than the placebo group. There were no significant differences in time to achieve sedation, incomplete procedures, procedure length, recovery room time, or complications. There were significantly higher observer ratings of the quality of sedation for patients who received droperidol. CONCLUSIONS: Droperidol is a useful adjunct to conscious sedation in patients who are difficult to sedate. Its use results in significantly fewer interruptions due to poor sedation and improved sedation ratings compared with sedation using midazolam and meperidine alone.

The Endocoil (Instent, Inc., Eden Prairie, MN), first introduced in 1993, is a self-expandable nitinol stent made of a coil spring of nickel-titanium alloy. Advantages of the Endocoil in patients with malignant biliary obstruction were thought to include increased radial force with more rapid stricture dilation, inhibition of tumor ingrowth caused by the stent's coil framework with closed approximation of loops, and the possibility for endoscopic removal. Unfortunately, in subsequent reports of patients undergoing Endocoil placement, there have been significant problems with incomplete expansion or twisting during deployment, stent migration, and tumor ingrowth. This article reviews the available literature regarding Endocoil placement for malignant biliary obstruction and addresses the authors' experience at a tertiary referral center.

BACKGROUND: Same-day discharge after endoscopic biliary sphincterotomy (ES) is a common clinical practice, but there have been few data to guide appropriate selection of patients. Using a prospective, multicenter database of complications, we examined outcomes after same-day discharge as it was practiced by a variety of endoscopists and evaluated the ability of a multivariate risk factor analysis to predict which patients would require readmission for complications. METHODS: A 150-variable database was prospectively collected at time of ES, before discharge and again at 30 days in consecutive patients undergoing ES at 17 centers. Complications were defined by consensus criteria and included all specific adverse events directly or indirectly related to ES requiring more than 1 night of hospitalization. RESULTS: Six hundred fourteen (26%) of 2347 patients undergoing ES were discharged on the same day as the procedure, ranging from none at 6 centers to about 50% at 2 centers. After initial observation and release, readmission to the hospital for complications occurred in 35 (5.7%) of 614 same-day discharge patients (20 pancreatitis and 15 other complications, 3 severe). Of the same-day discharge patients, readmission was required for 14 (12.2%) of 115 who had at least one independently significant multivariate risk factor for overall complications (suspected sphincter of Oddi dysfunction, cirrhosis, difficult bile duct cannulation, precut sphincterotomy, or combined percutaneous-endoscopic procedure) versus 21 (4.2%) of 499 without a risk factor (odds ratio 3.1: 95% confidence interval [1.6, 6.3], p < 0.001). Of complications presenting within 24 hours after ES, only 44% presented within the first 2 hours, but 79% presented within 6 hours. CONCLUSIONS: Same-day discharge is widely utilized and relatively safe but results in a significant number of readmissions for complications. For patients at higher risk of complications, as indicated by the presence of at least one of five independent predictors, observation for 6 hours or overnight may reduce the need for readmission.