Kees Huibregtse

Randomised trial of self-expanding metal stents versus polyethylene stents for distal malignant biliary obstruction

Self-expanding metal stents are claimed to prolong biliary-stent patency, although no formal comparative trial between plastic and expandable stents has been done. In a prospective randomised trial, we assigned 105 patients with irresectable distal bile-duct malignancy to receive either a metal stent (49) or a straight polyethylene stent (56). Median patency of the first stent was significantly prolonged in patients with a metal stent compared with those with a polyethylene stent (273 vs 126 days; p = 0.006). The major cause of stent dysfunction was tumour ingrowth in the metal-stent group and sludge deposition in the polyethylene-stent group. Treatment after any occlusion included placement of a polyethylene stent. In the metal-stent group none of 14 second stents occluded, whereas 11 of 23 (48%) second stents clogged in the polyethylene-stent group (p = 0.002). Overall median survival was 149 days and did not differ significantly between treatment groups. Incremental cost-effectiveness analysis showed that initial placement of a metal stent results in a 28% decrease of endoscopic procedures. Self-expanding metal stents have a longer patency than polyethylene stents and offer adequate palliation in patients with irresectable malignant distal bile-duct obstruction.

Randomised trial of endoscopic balloon dilation versus endoscopic sphincterotomy for removal of bileduct stones

BACKGROUND Endoscopic sphincterotomy (EST) for the removal of bileduct stones is associated with acute complications and a permanent loss of biliary-sphincter function. Endoscopic balloon dilation (EBD) causes less trauma to the biliary sphincter, but may be less effective in allowing stone removal. METHODS 218 consecutive patients with bileduct stones on endoscopic retrograde cholangiopancreatography (ERCP) were enrolled. 202 who met all eligibility criteria were randomly assigned EST or EBD. The patients were observed in hospital for at least 24 h and followed up at 1 month and 6 months. Complications were classified by an expert panel unaware of treatment allocation and outcome. Analysis was done by intention to treat. FINDINGS After a single ERCP, all stones were removed from 92 (91%) of 101 patients assigned EST and 90 (89%) of 101 assigned EBD (p = 0.81); in nine of the latter, successful removal required additional EST. Mechanical lithotripsy was used to fragment stones in 31 EBD procedures and 13 EST procedures (p < 0.005). Early complications (before 15 days) occurred in 24 EST patients and 17 EBD patients (p = 0.29). One patient died of retroperitoneal perforation after EBD. Four patients had bleeding after EST. Seven patients in each group had pancreatitis. Complications during follow-up occurred in 23 EST patients and 18 EBD patients (p = 0.48). Acute cholecystitis was observed in seven EST patients and one EBD patient (p < 0.05). INTERPRETATION The success rate of EBD was similar to that of EST. We found there is no evidence of the previously suggested higher risk of pancreatitis with EBD and suggest that EBD is preferred in patients at risk of bleeding after EST. Preservation of biliary-sphincter function after EBD may prevent long-term complications and reduce the risk of acute cholecystitis during follow-up. This procedure is a valuable alternative to EST in patients with bileduct stones.

Treatment of bile duct lesions after laparoscopic cholecystectomy.

From January 1990 to June 1994, 53 patients who sustained bile duct injuries during laparoscopic cholecystectomy were treated at the Amsterdam Academic Medical Centre. There were 16 men and 37 women with a mean age of 47 years. Follow up was established in all patients for a median of 17 months. Four types of ductal injury were identified. Type A (18 patients) had leakage from cystic ducts or peripheral hepatic radicles, type B (11 patients) had major bile duct leakage, type C (nine patients) had an isolated ductal stricture, and type D (15 patients) had complete transection of the bile duct. Endoscopic retrograde cholangiopancreatography (ERCP) established the diagnosis in all type A, B, and C lesions. In type D lesions percutaneous cholangiography was required to delineate the proximal extent of the injury. Initial treatment (until resolution of symptoms and discharge from hospital) comprised endoscopy in 36 patients and surgery in 26 patients. Endoscopic treatment was possible and successful in 16 of 18 of type A lesions, five of seven of type B lesions, and three of nine of type C lesions. Most failures resulted from inability to pass strictures or leaks at the initial endoscopy. During initial treatment additional surgery was required in seven patients. Fourteen patients underwent percutaneous or surgical drainage of bile collections, or both. After endoscopic treatment early complications occurred in three patients, with a fatal outcome in two (not related to the endoscopic therapy). During follow up six patients developed late complications. All 15 patients with complete transection and four patients with major bile duct leakage were initially treated surgically. During initial treatment additional endoscopy was required in two patients. Early complications occurred in eight patients. During follow up seven patients developed stenosis of the anastomosis or bile duct. Reconstructive surgery in the early postoperative phase was associated with more complications than elective reconstructive surgery. Most type A and B bile duct injuries after laparoscopic cholecystectomy (80%) can be treated endoscopically. In patients with more severe ductal injury (type C and D) reconstructive surgery is eventually required in 70%. Multidisciplinary approach to these lesions is advocated and algorithms for treatment are proposed.

The efficacy of endoscopic treatment of pancreatic pseudocysts

BACKGROUND Endoscopic drainage of pancreatic pseudocysts is a new nonsurgical treatment modality. We retrospectively studied the efficacy of endoscopic drainage of pseudocysts in 37 patients with chronic pancreatitis. METHODS Endoscopic retrograde pancreatic drainage was performed in 12 patients, endoscopic cystogastrostomy in 10 patients, and endoscopic cystoduodenostomy in 7 patients. In the remaining 8 patients, combinations of drainage routes were used. RESULTS ECG failed in 3 patients. Procedure-related complications were seen in 6 patients: bleeding in 3, perforation in 2, and apnea in 1 patient. There was no procedure-related mortality. Seven patients had complications in relation to stents or drains: pseudocyst infection due to stent clogging in 2, stent migration in 4, and kinking of the drain in 1 patient. Twenty-four patients had complete resolution of pseudocysts, 7 had partial resolution, and 6 had no resolution. Three patients had pseudocyst recurrences. Mean follow-up was 32 months. Finally, 10 patients underwent surgery. CONCLUSIONS Endoscopic drainage was technically feasible in 92% of the patients. Procedure-related morbidity was 16% and mortality was 0%. Endoscopic drainage was a definitive treatment for two thirds of the patients (65%). Surgery can be reserved for those patients in whom endoscopic therapy fails.

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.

Long-term results of pancreatic stents in chronic pancreatitis

BACKGROUND Pancreatic stenting is a new nonsurgical treatment for patients with chronic pancreatitis and pain. We studied the long-term safety and efficacy of pancreatic stenting. METHODS Between 1982 and 1993, 51 patients with chronic pancreatitis and persistent pain with dominant strictures in the pancreatic duct were treated with plastic pancreatic stents. RESULTS Stent insertion was successful in 49 of 51 patients. Early complications occurred in 9 of the 51 patients (18%). Patients were followed for a median of 34 months (range 6 to 128). Nine of the 49 patients (82%) had clinical improvement. Sixteen of these 40 patients still had their stents in place. Stents were removed in 22 of the 40 patients with persistent beneficial response in all (median follow-up 28.5 months). The long-term effect of stenting could not be evaluated in the remaining 2 patients because they had a double bypass operation. Stent dysfunction occurred in 27 of the 49 patients (55%) and was successfully treated by exchanging the stent. CONCLUSIONS Pancreatic stenting was associated with minimal early complications, but stent dysfunction remained a frequent late complication. Pancreatic drainage resulted in clinical improvement in 40 of the 49 patients (82%). Twenty-two of these 40 patients maintained the beneficial response after stent removal (28.5 months).

Long-term follow-up after endoscopic sphincterotomy for bile duct stones in patients younger than 60 years of age

BACKGROUND Little is known about the long-term effects of endoscopic biliary sphincterotomy. METHODS We retrospectively evaluated the rate of late complications after endoscopic sphincterotomy (EST) for bile duct stones. Patients had to meet the following inclusion criteria: (1) treated between 1976 and 1980, (2) complete stone removal after EST, (3) prior cholecystectomy or elective cholecystectomy within 2 months after EST, and (4) 60 years old or younger at the time of ERCP. A total of 100 patients were identified. Information was obtained from general practitioners and patients by telephone. Patients completed a postal questionnaire and a blood sample was obtained for liver function tests. RESULTS Information was obtained for 94 patients (in the majority of cases [87%] from multiple sources). There were 26 men and 68 women with a mean age of 51 years at the time of ERCP (range, 23 to 60 years). Early complications (< 30 days) occurred in 14 patients (15%). One patient died of a retroperitoneal perforation secondary to EST. During a median period of 15 years (range, 3 to 18 years), 22 patients (24%) developed a total of 36 late complications. There were 21 patients with symptoms of recurrent bile duct stones and one patient with biliary pancreatitis. Other late complications, such as recurrent ascending cholangitis or malignant degeneration, were not observed. An ERCP was performed in 20 of the 22 patients with late complications and demonstrated bile duct stones in 13, combined with stenosis of the EST opening in 9 patients. Late complications were initially managed endoscopically and/or conservatively. One patient underwent surgery after failed endoscopic treatment and one patient died of cholangitis before she could undergo an ERCP. Twelve other patients died of unrelated causes during follow-up. CONCLUSIONS After EST for bile duct stones, late complications occur in a significant proportion of patients. Stone recurrence remains the most important problem, but can in general be managed endoscopically.

Benign biliary strictures. Surgery or endoscopy

OBJECTIVE This study compared the results of surgery and endoscopy for benign biliary strictures in one institution, over the same period of time and with the same outcome definitions. SUMMARY BACKGROUND DATA Surgery is considered the treatment of choice, offering more than 80% long-term success. Endoscopic stenting has been reported to yield similar results and might be a useful alternative. METHODS In this nonrandomized retrospective study, 101 patients with benign biliary strictures were included. Thirty-five patients were treated surgically and 66 by endoscopic stenting. Patient characteristics, initial trauma, previous repairs, and level of obstruction were comparable in both groups. Surgical therapy consisted of constructing a biliary-digestive anastomosis in normal ductal tissue. Endoscopic therapy consisted of placement of endoprostheses, with trimonthly elective exchange for a 1-year period. RESULTS Mean length of follow-up was 50 +/- 3.8 and 42 +/- 4.2 months for surgery and endoscopy, respectively. Early complications occurred more frequently in the surgically treated group (p < 0.03). Late complications during therapy, occurred only in the endoscopically treated group. In 46 patients, the endoprostheses were eventually removed. Recurrent stricturing occurred in 17% in both surgical and endoscopic patients. CONCLUSIONS Surgery and endoscopy for benign biliary strictures have similar long-term success rates. Indications for surgery are complete transections, failed previous repairs, and failures of endoscopic therapy. All other patients are candidates for endoscopic stenting as the initial treatment.

Impaired Quality of Life 5 Years After Bile Duct Injury During Laparoscopic Cholecystectomy: A Prospective Analysis

ObjectiveTo assess the impact of bile duct injury (BDI) sustained during laparoscopic cholecystectomy on physical and mental quality of life (QOL). Summary Background DataThe incidence of BDI during laparoscopic cholecystectomy has decreased but remains as high as 1.4%. Data on the long-term outcome of treatment in these patients are scarce, and QOL after BDI is unknown. MethodsOne hundred six consecutive patients (75 women, median age 44 ± 14 years) were referred between 1990 and 1996 for treatment of BDI sustained during laparoscopic cholecystectomy. Outcome was evaluated according to the type of treatment used (endoscopic or surgical) and the type of injury. Objective outcome (interventions, hospital admissions, laboratory data) was evaluated, a questionnaire was filled out, and a QOL survey was performed (using the SF-36). Risk factors for a worse outcome were calculated. ResultsMedian follow-up time was 70 months (range 37–110). The objective outcome of endoscopic treatment (n = 69) was excellent (94%). The result of surgical treatment (n = 31) depended on the timing of reconstruction (overall success 84%; in case of delayed hepaticojejunostomy 94%). Five patients underwent interventional radiology with a good outcome. Despite this excellent objective outcome, QOL appeared to be both physically and mentally reduced compared with controls (P < .05) and was not dependent on the type of treatment used or the severity of the injury. The duration of the treatment was independently prognostic for a worse mental QOL. ConclusionsDespite the excellent functional outcome after repair, the occurrence of a BDI has a great impact on the patient’s physical and mental QOL, even at long-term follow-up.

Endoscopic pancreatic drainage in chronic pancreatitis

A nasopancreatic drain, pancreatic duct endoprostheses, and pancreatic stone extraction were used to treat 32 patients with chronic pancreatitis. Thirty patients were treated endoscopically. Endoscopic treatment via the minor papilla in 2 patients with pancreas divisum was not performed. Three patients had subsequent surgery because of complications; one of them died. Seventeen patients with chronic relapsing pancreatitis improved, with 15 patients asymptomatic during a follow-up of 2 to 69 months (median, 11). Seven of 10 patients with chronic pain improved, with 6 patients pain-free during a follow-up of 10 to 34 months (median, 11). In 7 patients, pancreatic pseudocysts could be drained endoscopically by positioning an endoprosthesis into the cyst or by performing a cystoduodenostomy. Six patients had concomitant placement of a biliary endoprosthesis to treat common bile duct strictures within the pancreatic head. One of 32 treated patients died as a result of a complication. We consider endoscopic therapy a viable alternative to surgery in select patients with chronic pancreatitis.