Endoscopic versus surgical drainage of the pancreatic duct in chronic pancreatitis.

BACKGROUND: For patients with chronic pancreatitis and a dilated pancreatic duct, ductal decompression is recommended. We conducted a randomized trial to compare endoscopic and surgical drainage of the pancreatic duct. METHODS: All symptomatic patients with chronic pancreatitis and a distal obstruction of the pancreatic duct but without an inflammatory mass were eligible for the study. We randomly assigned patients to undergo endoscopic transampullary drainage of the pancreatic duct or operative pancreaticojejunostomy. The primary end point was the average Izbicki pain score during 2 years of follow-up. The secondary end points were pain relief at the end of follow-up, physical and mental health, morbidity, mortality, length of hospital stay, number of procedures undergone, and changes in pancreatic function. RESULTS: Thirty-nine patients underwent randomization: 19 to endoscopic treatment (16 of whom underwent lithotripsy) and 20 to operative pancreaticojejunostomy. During the 24 months of follow-up, patients who underwent surgery, as compared with those who were treated endoscopically, had lower Izbicki pain scores (25 vs. 51, P<0.001) and better physical health summary scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey questionnaire (P=0.003). At the end of follow-up, complete or partial pain relief was achieved in 32% of patients assigned to endoscopic drainage as compared with 75% of patients assigned to surgical drainage (P=0.007). Rates of complications, length of hospital stay, and changes in pancreatic function were similar in the two treatment groups, but patients receiving endoscopic treatment required more procedures than did patients in the surgery group (a median of eight vs. three, P<0.001). CONCLUSIONS: Surgical drainage of the pancreatic duct was more effective than endoscopic treatment in patients with obstruction of the pancreatic duct due to chronic pancreatitis. (Current Controlled Trials number, ISRCTN04572410 [controlled-trials.com].).

Long-term results of endoscopic drainage of common bile duct strictures in chronic pancreatitis.

OBJECTIVES: Endoscopic stent therapy is an established treatment modality for postoperative biliary strictures. At present, biliary stenting is also widely applied in chronic pancreatitis (CP), but results regarding long-term outcome are scarce. METHODS: All CP patients who underwent endoscopic biliary drainage of a benign stricture in our hospital between 1987 and 2000 were included in this retrospective study. RESULTS: Fifty-eight CP patients underwent biliary stenting (median age, 54 years; 44 male). The procedure-related mortality rate was 2% and the complication rate 4%. Median follow-up was 45 months (range, 0-182 months). Endoscopic treatment was successful in 22 patients (38%). Concomitant acute pancreatitis was the only factor identified as predictive of a successful outcome by multivariate analyses. Subanalysis of these 12 patients revealed a success rate of 92%, as opposed to 24% in cases without acute inflammation. In this latter group, continued stenting beyond a 1-year period almost never resulted in additional stricture resolvement. If stricture resolution was accomplished, however, no recurrences were observed. CONCLUSIONS: For biliary strictures due to CP, without evidence of concomitant acute pancreatitis, the long-term success rate of endoscopic therapy is poor and only one out of four strictures is treated successfully. When a biliary stricture has not resolved after 1 year of endoscopic stenting, surgery should be considered.

A prospective randomized trial of Tannenbaum-type Teflon-coated stents versus polyethylene stents for distal malignant biliary obstruction.

OBJECTIVE: Stent clogging is a major limitation in the palliative treatment of malignant biliary obstruction. Preliminary studies suggested improved duration of patency of a Tannenbaum design stent with a stainless steel mesh and an inner Teflon coating (TTC). We compared the patency of a TTC stent with a conventional polyethylene (PE) stent in a prospective randomized trial. METHODS: Between February 1998 and September 1998 we included 60 patients with distal malignant bile duct obstruction. Diagnosis included carcinoma of the pancreas (n = 57) and ampullary cancer (n = 3). There were 29 men and 31 women with a median age of 77 years. Stent diameter (10 Fr) and length (11 cm) were similar but both stent design and material were different: a Tannenbaum design stent with a stainless steel mesh and an inner Teflon coating, and an Amsterdam-type PE stent. RESULTS: Sixty patients were evaluated; 30 in the TTC group and 30 in the PE group. Early complications occurred in two patients in each group. Stent dysfunction occurred in 18 of TTC stents and 12 of PE stents. Median stent patency was 102 days for TTC and 142 days for PE stents (P = 0.41). Median survival did not differ significantly for both treatment groups (TTC, 121 days; PE, 105 days). Stent migration, in all cases proximal into the common bile duct, occurred in four patients in the TTC group versus zero in the PE group (P = 0.038). CONCLUSIONS: This study did not confirm improved patency of Tannenbaum-type Teflon-coated stents. Proximal migration prompts for additional design modifications.

Endoscopic palliation of patients with biliary obstruction caused by nonresectable hilar cholangiocarcinoma: efficacy of self-expandable metallic Wallstents.

BACKGROUND: The aim of this study was to evaluate the efficacy of an endoscopically inserted self-expandable metal stent for treatment of biliary obstruction caused by nonresectable hilar cholangiocarcinoma. METHODS: Data on all patients with nonresectable hilar cholangiocarcinoma receiving self-expandable metal stents between January 1990 and April 2000 were retrospectively reviewed. Patients with pseudo Klatskin tumors (metastases in the liver hilum) and gallbladder carcinoma were excluded. Early complications (within 30 days of stent placement), early and late stent occlusion, stent patency, and biliary reintervention rates were recorded. RESULTS: Fifty-two Wallstents were inserted in 36 patients, with 7, 13, and 16 having, respectively, Bismuth type I/II, III, and IV lesions. Insertion was successful in 35 of 36 (97%) patients. Complications occurred within the first 30 days after insertion in 5 patients (14%) but did not require biliary reintervention. Thirty-day mortality was 6% (2 deaths). There were 3 early (9%) and 8 late (23%) stent occlusions, bringing the total to 11 patients (31%) who required biliary reintervention after Wallstent insertion. Median Wallstent patency and patient survival were, respectively, 169 days (95% CI [154, 184]) and 147 days (95% CI [106, 188]), with no difference between patients with Bismuth I/II, III, IV type tumors. CONCLUSIONS: Wallstent insertion is safe and feasible, and achieves successful palliation without the need for further biliary reintervention in the majority (69%) of patients with nonresectable hilar cholangiocarcinoma.

Wait-and-see policy or laparoscopic cholecystectomy after endoscopic sphincterotomy for bile-duct stones: a randomised trial.

BACKGROUND: Patients who undergo endoscopic sphincterotomy for common bile-duct stones, who have residual gallbladder stones, are referred for laparoscopic cholecystectomy. However, only 10% of patients who do not have this operation are reported to develop recurrent biliary symptoms. We aimed to assess whether a wait-and-see policy is justified. METHODS: We did a prospective, randomised, multicentre trial in 120 patients (age 18-80 years) who underwent endoscopic sphincterotomy and stone extraction, with proven gallbladder stones. Patients were randomly allocated to wait and see (n=64) or laparoscopic cholecystectomy (56). Primary outcome was recurrence of at least one biliary event during 2-year follow-up, and secondary outcomes were complications of cholecystectomy and quality of life. Analysis was by intention to treat. FINDINGS: 12 patients were lost to follow-up immediately. Of 59 patients allocated to wait and see, 27 (47%) had recurrent biliary symptoms compared with one (2%) of 49 patients after laparoscopic cholecystectomy (relative risk 22.42, 95% CI 3.16-159.14, p<0.0001). 22 (81%) of 27 patients underwent cholecystectomy, mainly for biliary pain (n=13) or acute cholecystitis (7). Conversion rate to open surgery was 55% in patients allocated to wait and see who underwent cholecystectomy compared with 23% in those who were allocated laparoscopic cholecystectomy (p=0.0104). Morbidity was 32% versus 14% (p=0.1048), and median hospital stay was 9 versus 7 days. Quality of life returned to normal within 3 months after either treatment policy. INTERPRETATION: A wait-and-see policy after endoscopic sphincterotomy in combined cholecystodocholithiasis cannot be recommended as standard treatment, since 47% of expectantly managed patients developed at least one recurrent biliary event and 37% needed cholecystectomy. No major biliary complications arose, but conversion rate was high.