Precut papillotomy versus persistence in difficult biliary cannulation: a prospective randomized trial.

BACKGROUND AND STUDY AIMS: Failed biliary cannulation occurs in up to 10% of patients undergoing ERCP. There is some controversy as to the safety and efficacy of using precut techniques to achieve biliary cannulation in difficult cases. To date, no randomized trial has compared the success and complication rates of precut with the rates for persistence when biliary cannulation is difficult. The aim of this study was to compare the success rates and complication rates of precut with the success rates and complication rates of persistence in cases of difficult biliary cannulation. PATIENTS AND METHODS: Patients without prior sphincterotomy who required biliary cannulation were screened. A "difficult biliary cannulation" was arbitrarily defined as failed cannulation after 12 minutes. These patients were then randomized to continue treatment by needle-knife cut over the roof of the papilla or by persistence with a non-wire-guided, single-lumen papillotome. "Primary" success was defined as deep cannulation within 15 minutes of randomization. Primary and final success rates and complication rates within 30 days after ERCP were compared. RESULTS: Over a 38-month period a total of 642 patients were screened. Patients in whom biliary cannulation was successful within a time period of 12 minutes or less formed the reference group (n = 580). The remainder of the patients were randomly assigned to the "precut" arm (n = 32) or to the "persistence" arm (n = 30). Primary success rates and complication rates were similar in the precut and persistence arms (75% and 4% respectively for the precut arm vs. 73% and 9% for the persistence arm). The final successful cannulation rate in the entire group of 642 patients was 99.5%. CONCLUSIONS: In experienced hands, precut papillotomy and persistence in cannulation are equally effective in cases of difficult cannulation, with a similar complication rate.

Sphincterotomy-associated biliary strictures: features and endoscopic management.

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.

A randomized, double-blind study of the use of droperidol for conscious sedation during therapeutic endoscopy in difficult to sedate patients.

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 stent for malignant biliary obstruction.

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.

Same-day discharge after endoscopic biliary sphincterotomy: observations from a prospective multicenter complication study. The Multicenter Endoscopic Sphincterotomy (MESH) Study Group.

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.

Outcome in patients with bifurcation tumors who undergo unilateral versus bilateral hepatic duct drainage.

BACKGROUND: There is much controversy as to the importance of establishing drainage of both liver lobes in malignant hilar obstruction. The purpose of the present study was to compare survival data in patients with malignant hilar obstruction, stratified according to the Bismuth classification, who had cholangiography with filling of one or both hepatic ducts and subsequently endoscopic or percutaneous drainage of one or both ducts. METHODS: A retrospective review was performed for the time period from July 1990 to July 1995, and 224 patients were identified with a presumed diagnosis of a bifurcation tumor. All x-ray films were reviewed and 150 patients finally diagnosed as hilar tumor were classified according to Bismuth type I, II, or III. Type II and III patients were further subclassified with respect to contrast injection into a single or both hepatic duct systems and whether one or both sides were eventually drained. RESULTS: Data were obtained in 141 patients (4 patients still alive); there were 43 type I, 58 type II, and 40 type III. Type II and III patients were divided into three groups: group A, one lobe opacified with same lobe drained; group B, both lobes opacified with both lobes drained; and group C, both lobes opacified with one lobe drained. Overall median survival for type I, II, and III patients was 160, 131, and 62 days, respectively. Among type II and III patients the median survivals of groups A, B, and C were 145, 225, and 46 days, respectively. Survival was significantly longer in group A vs. group C (p < 0.001), group B vs. group C (p < 0.001, and group A + B (165 days) vs. group C p < 0.001). There was no difference in group A + B versus type I (p=0.90). In addition, when comparing single drain only (group A + C, 80 days) versus double drains (group B, 225 days), there was a significant survival advantage (p < 0.0001). CONCLUSION: In bifurcation tumors the best survival was noted in those with bilateral drainage, and the worst survival in those with cholangiographic opacification of both lobes but drainage of only one.

Watermelon stomach.

Watermelon stomach (WMS) is an uncommon cause of chronic gastrointestinal blood loss, which once suspected can often be easily diagnosed and endoscopically managed in most cases. The current review intends to heighten the gastroenterologist's awareness of this condition to avoid costly delays in its diagnosis. The characteristic endoscopic appearance of WMS and the other variants of gastric vascular ectasia (GVE) are described. The conditions often associated with WMS are reviewed, including the recently described occurrence of WMS in bone marrow transplant patients presenting with acute upper gastrointestinal hemorrhage. We have clearly differentiated GVE from portal hypertensive gastropathy. The biopsy findings, although usually not required for diagnosis, are discussed. The theories of pathogenesis of WMS are presented and their relation to the observed phenomena is explored. Finally, the management of GVE, which essentially involves endoscopic application of thermal ablation methods, and the newer developments in the field, such as argon plasma coagulation, are discussed.

Photodynamic therapy for the treatment of tumor ingrowth in expandable esophageal stents.

BACKGROUND AND STUDY AIMS: Tumor ingrowth through self-expanding metal stents presents a difficult problem for management. The techniques for treating tumor ingrowth have not yet been well described, and the optimal endoscopic approach is not clear. We have recently used photodynamic therapy (PDT) to treat tumor ingrowth through uncovered nitinol mesh stents. PATIENTS AND METHODS: Four patients (mean age 73) with obstructive adenocarcinomas of the distal esophagus had received self-expanding stents for palliation of their dysphagia. After stent placement, tumor ingrowth had caused progressive dysphagia in all of the patients; the dysphagia was graded on a scale from 0 (normal) to 4 (inability to swallow liquids). All of the patients received PDT treatment. RESULTS: After PDT, excellent palliation of the dysphagia was seen in all of the patients, with a mean improvement in the dysphagia score of 2.25 and a mean dysphagia-free interval of 92 days. There were no major complications. CONCLUSION: The use of PDT to treat tumor ingrowth through self-expanding metal esophageal stents is effective and safe.

A prospective study of the repeated use of sterilized papillotomes and retrieval baskets for ERCP: quality and cost analysis.

BACKGROUND: The impact on instrument quality and cost of the practice of reusing ERCP accessories has not been fully addressed. METHODS: Twenty-five new papillotomes and 15 new retrieval baskets were labeled and evaluated over time by staff blinded to the number of prior uses. Instruments were scored as to their function for the designated task. The cost of this practice was calculated from the purchase price of accessories and the costs of cleaning, sterilization, and disposal, and then compared with the estimated cost of a practice of one-time use of similar instruments. RESULTS: Twenty-five papillotomes were used 246 times (median 8; mean 9.8). Fifteen retrieval baskets were used 193 times (median 13; mean 12.9). The median survival of both papillotomes and baskets before being considered inadequate (score < 6 out of 10) was 9 uses. There were no complications attributable to using reused equipment. The projected yearly cost savings of using reusable versus disposable instruments was $94,095 for papillotomes and $61,809 for baskets, a 475% and 322% cost reduction, respectively. CONCLUSION: The papillotomes and baskets in this study could be reused reliably and safely multiple times, with considerable cost savings compared with the practice of using disposable instruments.

Future of endoscopy in nonvariceal upper gastrointestinal bleeding. What remains to be done.

The centennial of the American Gastroenterological Association provides an occasion for a critical appraisal of past developments and future directions in endoscopy. The relevance of recent technologic advances in endoscopy must be questioned, and practical management issues need to be considered. New strategies are being developed that permit physicians to impact on the incidence and recurrence of bleeding peptic ulcers.

Complications of endoscopic biliary sphincterotomy.

BACKGROUND: Endoscopic sphincterotomy is commonly used to remove bile-duct stones and to treat other problems. We prospectively investigated risk factors for complications of this procedure and their outcomes. METHODS: We studied complications that occurred within 30 days of endoscopic biliary sphincterotomy in consecutive patients treated at 17 institutions in the United States and Canada from 1992 through 1994. RESULTS: Of 2347 patients, 229 (9.8 percent) had a complication, including pancreatitis in 127 (5.4 percent) and hemorrhage in 48 (2.0 Percent). There were 55 deaths from all causes within 30 days; death was directly or indirectly related to the procedure in 10 cases. Of five significant risk factors for complications identified in a multivariate analysis, two were characteristics of the patients (suspected dysfunction of the sphincter of Oddi as an indication for the procedure and the presence of cirrhosis) and three were related to the endoscopic technique (difficulty in cannulating the bile duct achievement of access to the bile duct by "precut" sphincterotomy, and use of a combined percutaneous-endoscopic procedure). The overall risk of complications was not related to the patient's age, the number of coexisting illnesses, or the diameter of the bile duct. The rate of complications was highest when the indication for the procedure was suspected dysfunction of the sphincter of Oddi (21.7 percent) and lowest when the indication was removal of bile-duct stones within 30 days of laparoscopic cholecystectomy (4.9 percent). As compared with those who performed fewer procedures, endoscopists who performed more than one sphincterotomy per week had lower rates of all complications (8.4 percent vs. 11.1 percent, P=0.03) and severe complications (0.9 percent vs. 2.3 percent, P=0.01). CONCLUSIONS: The rate of complications after endoscopic biliary sphincterotomy can vary widely in different circumstances and is primarily related to the indication for the procedure and to endoscopic technique, rather than to the age or general medical condition of the patients.

A prospective study of the safety of endoscopic therapy for choledocholithiasis in an outpatient population.

OBJECTIVE: Many centers routinely admit patients for observation after endoscopic therapy of choledocholithiasis although this is contrary to the current mandate for cost containment. The purpose of this study was to determine the safety, success, and complication rates of outpatient therapeutic ERCP in the management of choledocholithiasis. METHODS: Over a 4-month period, 97 consecutive outpatients undergoing endoscopic treatment for choledocholithiasis were enrolled in a prospective manner. Each subject was observed 1-3 h postprocedure before discharge with follow-up at 10 days. RESULTS: Successful endoscopic management of choledocholithiasis was achieved in 100% of patients. Complication rates were as follows: pancreatitis (2.1%), postsphincterotomy bleeding (3.2%), perforation (0%), and sepsis (0%). One patient required admission during the observation period, and two others with pancreatitis were readmitted within 24 h of discharge. There was no apparent adverse clinical outcome related to this policy. CONCLUSION: Endoscopic therapy of choledocholithiasis may be performed safely on an outpatient basis, realizing significant cost savings.

Transpapillary choledochoscopy.

This article reviews the current and future applications of peroral endoscopic choledochoscopy. As endoscopic technology has evolved with smaller, more durable miniscopes, the range of diagnostic and therapeutic uses has increased proportionately. The success of intraductal lithotripsy coupled with the advent of miniscopes that can be used through standard duodenoscopes will enable most endoscopists to remove almost all bile duct stones. Similarly, the accuracy of tissue sampling and tumor staging will be enhanced. The clinical impact of these developments are reviewed.