Peter B. Cotton

Randomised trial of endoscopic steriting versus surgical bypass in malignant low bileduct obstruction

The development of non-surgical techniques for the relief of malignant low bileduct obstruction has cast doubt on the best way of relieving jaundice, particularly in patients fit for surgery whose life expectancy is more than a few weeks. We did a randomised prospective controlled trial comparing endoscopic stent insertion and surgical biliary bypass in patients with malignant low bileduct obstruction. 204 patients were randomised (surgery 103, stent 101); 3 subsequently proved to have benign disease and were excluded, leaving 101 surgical and 100 stented patients for assessment. Technical success was achieved in 94 surgical and 95 stented patients, with functional biliary decompression obtained in 92 patients in both groups. In stented patients, there was a lower procedure-related mortality (3% vs 14%, p = 0.01), major complication rate (11% vs 29%, p = 0.02), and median total hospital stay (20 vs 26 days, p = 0.001). Recurrent jaundice occurred in 36 stented patients and 2 surgical patients. Late gastric outlet obstruction occurred in 17% of stented patients and 7% of the surgical group. Despite the early benefits of stenting there was no significant difference in overall survival between the two groups (median survival: surgical 26 weeks; stented 21 weeks; p = 0.065). Endoscopic stenting and surgery are effective palliative treatments with the former having fewer early treatment-related complications and the latter fewer late complications.

A lexicon for endoscopic adverse events: report of an ASGE workshop

Patients and practitioners expect that their endoscopy procedures will go smoothly and according to plan. There are several reasons why they may be disappointed. The procedure may fail technically (eg, incomplete colonoscopy, failed biliary cannulation). It may seem to be successful technically but turn out to be clinically unhelpful (eg, a diagnosis missed, an unsuccessful treatment), or there may be an early relapse (eg, stent dysfunction). In addition, some patients and relatives may be disappointed by a lack of courtesy and poor communication, even when everything otherwise works well. The most feared negative outcome is when something ‘‘goes wrong’’ and the patient experiences a ‘‘complication.’’ This term has unfortunate medicolegal connotations and is perhaps better avoided. Describing these deviations from the plan as ‘‘unplanned events’’ fits nicely

Mechanisms of major biliary injury during laparoscopic cholecystectomy.

Laparoscopic cholecystectomy has become the procedure of choice for surgical removal of the gallbladder. The most significant complication of this new technique is injury to the bile duct. Twelve cases of bile duct injury during laparoscopic cholecystectomy were reviewed. Eight injuries were of a classic type: misidentification of the common duct for the cystic duct, resection of part of the common and hepatic ducts, and associated right hepatic arterial injury. Another injury was similar: clip ligation of the distal common duct with proximal ligation and division of the cystic duct, resulting in biliary obstruction and leakage. Three complications arose from excessive use of cautery or laser in the region of the common duct, resulting in biliary strictures. Evaluation of persistent diffuse abdominal pain led to the recognition of ductal injury in most patients. Ultimately, 10 patients required a Roux-en-Y hepaticojejunostomy to provide adequate biliary drainage. One patient had a successful direct common duct repair, and the remaining patient underwent endoscopic dilatation.

Endoscopic gastrojejunostomy with survival in a porcine model

BACKGROUND We have previously reported the feasibility and the safety of an endoscopic transgastric approach to the peritoneal cavity in a porcine model. We now report successful performance of endoscopic gastrojejunostomy with survival. METHODS All procedures were performed on 50-kg pigs, with the pigs under general anesthesia, in aseptic conditions with sterilized endoscopes and accessories. The stomach was irrigated with antibiotic solution, and a gastric incision was performed with a needle-knife and a sphincterotome. A standard upper endoscope was advanced through a sterile overtube into the peritoneal cavity. A loop of jejunum was identified, was retracted into the stomach, and was secured with sutures while using a prototype endoscopic suturing device. An incision was made into the jejunal loop with a needle-knife, and the filet-opened ends of the jejunal wall were secured to the gastric wall with a second line of sutures, completing the gastrojejunostomy. OBSERVATIONS Two pigs survived for 2 weeks. Endoscopy and a radiographic contrast study performed after gastrojejunostomy revealed a patent anastomosis with normal-appearing gastric and jejunal mucosa. Postmortem examination demonstrated a well-healed anastomosis without infection or adhesions. CONCLUSIONS The endoscopic transgastric approach to create a gastrojejunostomy is technically feasible and can be performed, with survival, in a porcine model.

Pancreatic stenting prevents pancreatitis after biliary sphincterotomy in patients with sphincter of Oddi dysfunction

BACKGROUND & AIMS Patients with sphincter of Oddi dysfunction are at high risk of developing pancreatitis after endoscopic biliary sphincterotomy. Impaired pancreatic drainage caused by pancreatic sphincter hypertension is the likely explanation for this increased risk. A prospective, randomized controlled trial was conducted to determine if ductal drainage with pancreatic stenting protects against pancreatitis after biliary sphincterotomy in patients with pancreatic sphincter hypertension. METHODS Eligible patients with pancreatic sphincter hypertension were randomized to groups with pancreatic duct stents (n = 41) or no stents (n = 39) after biliary sphincterotomy. The primary measured outcome was pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP). RESULTS Pancreatic stenting significantly decreased the risk of pancreatitis from 26% to 7% (10 of 39 in the no stent group and 3 of 41 in the stent group; P = 0.03). Only 1 patient in the stent group developed pancreatitis after sphincterotomy, and 2 others developed pancreatitis at the time of stent extraction. Patients in the no stent group were 10 times more likely to develop pancreatitis immediately after sphincterotomy than those in the stent group (relative risk, 10.5; 95% confidence interval, 1.4-78.3). CONCLUSIONS Pancreatic duct stenting protects significantly against post-ERCP pancreatitis in patients with pancreatic sphincter hypertension undergoing biliary sphincterotomy. Stenting of the pancreatic duct should be strongly considered after biliary sphincterotomy for sphincter of Oddi dysfunction; pancreatic sphincter of Oddi manometry identifies which high-risk patients may benefit from pancreatic stenting.

Risk factors for complications after ERCP: a multivariate analysis of 11,497 procedures over 12 years

BACKGROUND Complications of ERCP are an important concern. We sought to determine predictors of post-ERCP complications at our institution. METHODS GI TRAC is a comprehensive data set of patients who underwent ERCP at our institution from 1994 through 2006. Logistic regression models were used to evaluate 4 categories of complications: (1) overall complications, (2) pancreatitis, (3) bleeding, and (4) severe or fatal complications. Independent predictors of complications were determined with multivariable logistic regression. RESULTS A total of 11,497 ERCP procedures were analyzed. There were 462 complications (4.0%), 42 of which were severe (0.36%) and 7 were fatal (0.06%). Specific complications of pancreatitis (2.6%) and bleeding (0.3%) were identified. Overall complications were statistically more likely among individuals with suspected sphincter of Oddi dysfunction (SOD) (odds ratio [OR] 1.91) and after a biliary sphincterotomy (OR 1.32). Subjects with a history of acute or chronic pancreatitis (OR 0.78) or who received a temporary small-caliber pancreatic stent (OR 0.69) had fewer complications. Post-ERCP pancreatitis was more likely to occur after a pancreatogram via the major papilla (OR 1.70) or minor papilla (OR 1.54) and among subjects with suspected SOD with stent placement (OR 1.45) or without stent placement (OR 1.84). Individuals undergoing biliary-stent exchange had less-frequent pancreatitis (OR 0.38). Biliary sphincterotomy was associated with bleeding (OR 4.71). Severe or fatal complications were associated with severe (OR 2.38) and incapacitating (OR 7.65) systemic disease, obesity (OR 5.18), known or suspected bile-duct stones (OR 4.08), pancreatic manometry (OR 3.57), and complex (grade 3) procedures (OR 2.86). CONCLUSIONS This study characterizes a large series of ERCP procedures from a single institution and outlines the incidence and predictors of complications.

Endoscopic Biliary Therapy Using the Combined Percutaneous and Endoscopic Technique

Between September 1985 and December 1987, 74 patients underwent attempted endoscopic biliary therapy using a combined percutaneous transhepatic and endoscopic transpapillary approach (combined procedure). All patients had had failed endoscopy-alone procedures and had contraindications to surgery. The indication was palliation of malignant biliary obstruction in 66 cases (41 common bile duct, 25 hilar), assistance with sphincterotomy for the removal of common bile duct stones in 6 cases, and management of benign biliary stenosis in 2 cases. The initial procedure was percutaneous transhepatic access to the biliary tree, which was successful in all but 1 case (99%). The bile duct was drained externally for an average of 3.4 days before the combined procedure. One patient died during this period from hemorrhage associated with liver puncture. Combined procedure was performed in 72 cases and was successful in 60 [53 malignant stricture (53/66 = 80%), five common duct stone (5/6 = 83%), two benign stricture (2/2 = 100%)]. Procedure-related morbidity and mortality, respectively, were 12.5% and 0% for benign disease and 36% and 3% for malignant disease. The total (initial endoscopy included) morbidity and 30-day mortality were 33% and 0%, respectively, for benign disease and 62% and 27% for malignant disease. Subsequently, stent change has been required on 16 occasions, with endoscopy-only successful in 13 (81%) and repeat combined procedure being required in three (19%). The combined procedure improves the ability of endoscopy to offer nonsurgical therapy to poor risk patients with both malignant and benign biliary disease but is associated with significant morbidity and disease-related mortality.

Palliation of proximal malignant biliary obstruction by endoscopic endoprosthesis insertion.

For four years up to December 1987, 190 patients (median age 73 years) with proximal malignant biliary obstruction were treated by endoscopic endoprosthesis insertion. Altogether 101 had cholangiocarcinoma, 21 gall bladder carcinoma, 20 local spread of pancreatic carcinoma, and 48 metastatic malignancy. Fifty eight patients had type I, 54 type II, and 78 type III proximal biliary strictures (Bismuth classification). All patients were either unfit or unsuitable for an attempt at curative surgical resection. A single endoprosthesis was placed initially, with a further stent being placed only if relief of cholestasis was insufficient or sepsis developed in undrained segments. The combined percutaneous-endoscopic technique was used to place the endoprosthesis when appropriate, after failed endoscopic endoprosthesis insertion or for second endoprosthesis placement. Full follow up was available in 97%.Thirteen patients were still alive at the time of review and all but one had been treated within the past six months. Initial endoprosthesis insertion succeeded technically at the first attempt in 127 patients, at the second in 30, and at a combined procedure in a further 13 (cumulative total success rate 89% - type I: 93%; type II: 94%; and type III: 84%). There was adequate biliary drainage after single endoprosthesis insertion in 152 of the 170 successful placements, giving an overall successful drainage rate of 80%. Three patients had a second stent placed by combined procedure because of insufficient drainage, giving an overall successful drainage rate of 82% (155 of 190). The final overall drainage success rates were type I: 91%; type II: 83%; and type III: 73%. The early complication rates were type I: 7%; type II: 14%; and type III: 31%. The principle early complication was clinical cholangitis, which occurred in 13 patients (7%) and required second stent placement in five. The 30 day mortality was 22% overall (type I: 14%; type II: 15%; and type III: 32%) but the direct procedure related mortality was only 3%. Median survival overall for types I, II, and III strictures were 21, 12, and 10 weeks respectively but survival was significantly shorter for metastatic than primary malignancy (p<0.05). Endoscopic insertion of a single endoprosthesis will provide good palliation of proximal malignant biliary obstruction caused by unresectable malignancy in 80% of patients. Second stents should be placed only if required. Extensive structuring because of metastatic disease carries a poor prognosis and careful patient selection for treatment is requires.

ENDOSCOPIC SPHINCTEROTOMY IN 1000 CONSECUTIVE PATIENTS

Between 1983 and 1988, endoscopic sphincterotomy was attempted on 1000 consecutive patients with a clinical diagnosis of bileduct stones in a centre with a policy to establish immediate bileduct drainage for retained stones. Endoscopic cholangiography was successful in 985 patients, of whom 782 had visible stones and 203 had a dilated bileduct but no visible stones. Endoscopic sphincterotomy was successful in 975 of these patients, with eventual bileduct clearance in 674 of 772 patients (87.3%) with visible stones; immediate bileduct drainage was achieved in 160 of the 161 patients (99%) in whom bileduct clearance failed at the first attempt. Overall, 771 of 797 patients (96.7%) with visible bileduct stones had successful bileduct clearance or drainage. Complications occurred in 6.9%, with a 30-day mortality rate of 1.2%, but procedure-related mortality was only 0.6%.

Comparative costs of metal versus plastic biliary stent strategies for malignant obstructive jaundice by decision analysis

BACKGROUND For palliation of patients with malignant obstructive jaundice, expansile metal stents provide longer patency than plastic stents but are more expensive. The optimal cost-effective strategy has not been established. Our aim was to compare the relative costs of 3 strategies: (1) plastic stent, with exchange on occlusion; (2) metal stent initially, with coaxial plastic stent insertion in the event of occlusion; or (3) plastic stent initially, with metal stent exchange in the event of occlusion. METHODS A decision analysis model was created using DATA 2.6 software to assess the relative costs of the three strategies. Values for variables including the probabilities of reintervention and patient survival were obtained from published data. Costs were based on Medicare reimbursements of hospital charges, and the model was evaluated from the perspective of a third-party payer. One-way and two-way sensitivity analysis of the variables was performed over a wide range. RESULTS The outcome is highly sensitive to the ratio of metal stent cost relative to endoscopic retrograde cholangiopancreatography cost (cost ratio M:ERCP) and to the length of survival of the patient. The most economical strategies were (2), (3) and (1) for M:ERCP cost ratios of <0.5, 0.5 to 0.7, and >0.7, respectively. CONCLUSIONS The choice of stent should be guided by the relative local costs of ERCP and metal stents and by the prognosis of the patient. At current metal stent costs and Medicare reimbursement rates, initial placement of a plastic stent, followed by metal stent placement at first occlusion in longer survivors, is an economical option. If metal stent cost is less than half of ERCP cost, then initial insertion of a metal stent would be most economical. Use of plastic stents is preferable for patients surviving less than 4 months, whereas metal stents are more economical for patients with longer survival.