Elsevier

The Lancet

Volume 348, Issue 9030, 21 September 1996, Pages 791-793
The Lancet

Early Report
Randomised study of endoscopic biliary endoprosthesis versus duct clearance for bileduct stones in high-risk patients

https://doi.org/10.1016/S0140-6736(96)06316-7Get rights and content

Summary

Background

The value of an endoprosthesis for long-term management of bileduct stones has not been formally established. The main theoretical advantage of endoprosthesis insertion (BE) over conventional endoscopic duct clearance (DC) is the prevention of stone impaction, with obstruction and consequent cholangitis or pancreatitis. In a randomised study we compared the results of these two methods in patients with symptomatic bileduct stones who were at high risk because of old age (>70 yr) or serious debilitating disease.

Methods

43 high-risk patients were randomised to BE with a 7F double-pigtail endoprosthesis and <075 cm sphincterotomy, and 43 to DC with standard 125–150 cm sphincterotomy and stone extraction by balloon or basket, with or without mechanical lithotripsy. The principal end-point was the rate of biliary related complications.

Findings

In the BE group biliary drainage was achieved in the first session in all but one patient (who required 2 sessions). In the DC group, 24 patients had duct clearance at the first attempt and 35 (81%) after a median of 2 sessions (range 2–4); eight of this group had an endoprosthesis inserted to maintain long-term drainage. At 72 h the complication rates were 7% in the BE group and 16% in the DC group (p=0·18). However, the long-term complication rate for BE was higher: by Kaplan-Meier analysis, at a median of 20 months the proportions free of biliary complications were 64% BE and 86% DC (p=0·03, log-rank test).

Interpretation

For immediate bileduct drainage, endoprosthesis insertion proved a safe and effective alternative to duct clearance. Because of the risk of subsequent cholangitis, its use as a definitive treatment should be confined to highly selected cases.

Introduction

Between 10% and 15% of patients with gallbladder stones will have associated common bileduct (CBD) stones1, and the likelihood of CBD stones increases with age; in one operative series2 the prevalence was 6% in patients under 60 years but 33% in those over 80 years. About one-third of patients with CBD stones get recurrent cholangitis or pancreatitis,4 and these complications carry a substantial morbidity and mortality in the elderly or infirm. Prompt intervention is required, to clear the duct of stones or to establish an uninterrupted flow of bile.

Endoscopic sphincterotomy and stone extraction is widely accepted as the initial treatment of choice for a patient of any age with choledocholithiasis; the bileduct can be cleared of stones in 90% of cases.5 This treatment is especially favoured in elderly patients, for whom surgical bileduct exploration carries a high morbidity and mortality.6 In the under-60 age group the mortality rate for common bileduct exploration is only 2% or less, but after 60 years of age it increases sharply, particularly when infectious complications such as suppurative cholangitis are present or when emergency procedures are required.4, 7

In unselected series, endoscopic sphincterotomy has had a 6-10% major complication rate and a 0-4-1-2% mortality rate.8 However, in high-risk elderly patients the major complication rate has been as high as 19% and the mortality rate 7-9%.4 Might the results be improved by use of a biliary endoprosthesis? Good results have been reported in small uncontrolled series with varying follow-up periods; and the postulated mechanism is that, by preventing stone impaction, the prosthesis lessens the risk of biliary obstruction and consequent cholangitis or pancreatitis. We report here a controlled study of endoprosthesis insertion versus standard duct clearance techniques for management of choledocholithiasis in elderly or debilitated patients.

Section snippets

Patients and methods

The patients, drawn from three centres in the United Kingdom, were either ⩾70 years of age or younger with a serious debilitating disease as defined by the American Society of Anesthesiology;9 for inclusion they had to have a single common bileduct stone >10 mm in diameter or two or more stones of any size.

All patients had an ultrasonographic evaluation of the pancreato-biliary system before endoscopic retrograde cholangiopancreatography (ERCP), which was done under antibiotic cover

Results

43 patients were randomised to BE and 43 to DC. The two groups were well matched for demographic and presenting clinical features (table 1). Table 2 lists the associated medical conditions. The preliminary endoscopy revealed a duodenal diverticulum in nine patients (BE five, DC four). The median number of stones in the bileduct was 1 in the BE group (range 1–5) and 2 in the DC group (1–20); and the median size of stones was 15 mm (range 10–25 mm) in both groups. A common bileduct stricture was

Discussion

In the present study an endoprosthesis proved highly successful for establishing biliary drainage in patients with bileduct stones. Drainage was achieved more quickly than with the duct clearance procedure and the early complication rate was lower, though not significantly so. In previous series both the double-pigtail 7F and straight stents have been reported effective in achieving biliary drainage.10, 11, 12, 13, 14 It was our own experience that prompted use of the 7F pigtail endoprosthesis

References (15)

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