Randomised trial of endoscopic sphincterotomy with gallbladder left in situ versus open surgery for common bileduct calculi in high-risk patients

doi:10.1016/S0140-6736(96)91413-0

The Lancet

Volume 347, Issue 9006, 6 April 1996, Pages 926-929

https://doi.org/10.1016/S0140-6736(96)91413-0 Get rights and content

Abstract

Summary

Background Morbidity and mortality after surgical treatment of bileduct stones increase with age and associated diseases. A proposed alternative therapy is endoscopic sphincterotomy (ES) with the gallbladder left in situ, and we elected to compare this option with standard open surgery in high-risk patients.

Methods 98 patients (mean age 80 years) with symptoms likely to be due to bileduct stones or a recent episode of biliary pancreatitis were randomised to be treated either by open cholecystectomy with operative cholangiography and (if necessary) bileduct exploration (n=48) or by endoscopic sphincterotomy alone (n=50).

Findings The procedure was accomplished successfully in 94% of the surgery group and 88% of the ES group, and there were no significant differences in immediate morbidity (23% vs 16%) or mortality (4% vs 6%). During mean follow-up of 17 months biliary symptoms recurred in three surgical patients, none of whom underwent repeat surgery, and in 10 ES patients, seven of whom had biliary surgery. By multivariate regression analysis endoscopic sphincterotomy was an independent predictor of recurrent biliary symptoms (odds ratio 6·9; 95% Cl 1·46 to 32·54).

Interpretation In elderly or high-risk patients, surgery is preferable to endoscopic sphincterotomy with the gallbladder left in situ as a definitive treatment for bileduct stones or non-severe biliary pancreatitis.

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Each year choledocholithiasis results in biliary obstruction, cholangitis, and pancreatitis in a significant number of patients. The primary treatment, ERCP, is minimally invasive but associated with adverse events in 6% to 15%. This American Society for Gastrointestinal Endoscopy (ASGE) Standard of Practice (SOP) Guideline provides evidence-based recommendations for the endoscopic evaluation and treatment of choledocholithiasis. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework was used to rigorously review and synthesize the contemporary literature regarding the following topics: EUS versus MRCP for diagnosis, the role of early ERCP in gallstone pancreatitis, endoscopic papillary dilation after sphincterotomy versus sphincterotomy alone for large bile duct stones, and impact of ERCP-guided intraductal therapy for large and difficult choledocholithiasis. Comprehensive systematic reviews were also performed to assess the following: same-admission cholecystectomy for gallstone pancreatitis, clinical predictors of choledocholithiasis, optimal timing of ERCP vis-à-vis cholecystectomy, management of Mirizzi syndrome and hepatolithiasis, and biliary stent therapy for choledocholithiasis. Core clinical questions were derived using an iterative process by the ASGE SOP Committee. This body developed all recommendations founded on the certainty of the evidence, balance of risks and harms, consideration of stakeholder preferences, resource utilization, and cost-effectiveness.
Expectant management of gallbladder stones after endoscopic removal of common bile duct stones
2017, International Journal of Surgery
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Patients with expectant management after endoscopic clearance of CBD, however, are prone to adverse complications such as biliary pain, acute cholecystitis, cholangitis and pancreatitis. Randomized studies have shown that cholecystectomy after ES reduces biliary events from 21-47% to 2–7% when compared to wait-and-see policy [3–6]. Nearly half of the patients managed with wait-and see policy have to undergo a subsequent cholecystectomy or an additional ERCP due to frequent episodes of biliary pain, cholecystitis or recurrent bile duct stones.
Wait-and-see policy after endoscopic sphincterotomy (ES) for common bile duct (CBD) stones in patients with concomitant gallbladder stones may lead to recurrent biliary complications. The aim of this study was to assess the short and long-term results of wait-and-see policy in patients with intact gallbladder after endoscopic clearance of CBD stones.
From January 1999 to December 2014 a total of 181 consecutive patients with intact gallbladder underwent ES for CBD stones. The main measures of outcome were long-term biliary complications, biliary related mortality, CBD stone recurrence and need for surgical interventions. Secondary outcomes were 30-day mortality and 30-day morbidity. Clinical data were retrospectively collected from hospital records and from the National Registry of Death.
During the median follow-up of 3.9 years (IQR 1.6–6.6) late biliary complications were observed in 24 (13.8%) patients. Cumulative biliary related morbidity at 3 and 5 years was 7.6% and 10.8%, respectively. CBD stone recurrence was observed in 9 (5.2%) patients. On-demand cholecystectomy was performed in 6 (3.3%) patients. 30-day mortality was 3.9% and 30–day morbidity 9.4%. Overall cumulative mortality rate at 3 and 5 years after ES was 31.4% and 49.7%, respectively. Long-term biliary related mortality was 1.7%. No significant difference in long term complications or biliary mortality was observed between patients< 75 or ≥75 years of age.
Prophylactic cholecystectomy after ES has been shown to reduce mortality even in high-risk patients. In our series late biliary related mortality and morbidity were relatively low, because a considerable number of patients died from non-biliary related causes.However, most biliary-related events seem to occur evenly during the follow-up after ES. A prompt risk assesment and consideration of surgical treatment during index admission may prevent late biliary –related complications.
Chapter 31 - Bile duct exploration and biliary-enteric anastomosis
2017, Blumgart's Surgery of the Liver, Biliary Tract and Pancreas: Sixth Edition
Chapter 36A - Stones in the bile duct: Clinical features and open surgical approaches and techniques
2016, Blumgart's Surgery of the Liver, Biliary Tract and Pancreas: Sixth Edition
Role and outcomes of laparoscopic cholecystectomy in the elderly
2014, International Journal of Surgery
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Advanced age is associated with significant comorbidity and limited functional reserve, so the patients have high risks of other systemic complications [10]. Two studies respectively by Targarona EM et al. [11] and Boerma D. et al. [12] in the past years show that in case of complicated gallstone disease endoscopic clearance of bile duct and successive LC offered more advantages than conservative treatment only. The real shakespearian problem derives from surgeon's reluctance to operate high-risk elderly patients.
Introduction: Laparoscopic cholecystectomy is the standard of treatment for gallstones disease and acute colecystitis. The prevalence of this disease increases with age and the population is aging in industrialized countries. So, in this study we report our experience in the treatment of gallstone disease in elderly patients, particularly analyzing the outcomes of laparoscopic approach. Methods: Between January 2010 and May 2014 we performed a total of 1227 cholecystectomies. In this retrospective study age group was the primary independent variable: 351 patients were 65–79 years of age and 65 were 80 years of age or older. Results: Only 65 patients (5.3%) of all population had primary open cholecystectomy, but the rate in young group was 3.7% respect the highest frequency (9.2%) in the elderly group. The conversion rate was higher (1.2%) in the older group but there was no significant difference with younger group. LC in emergency setting was performed in 10.3% of young patients and in 13.8% of elderly group. Conclusion: Laparoscopic cholecystectomy is a feasible and safe procedure in elderly patients and might be performed during the same hospitalization like definitive treatment of gallstone disease. The old age and subsequent comorbidity are the fundamental predictor of surgical outcomes. Elective treatment should be recommended when repeated gallstone symptoms have occurred in the elderly patient before the development of acute cholecystitis and related complications.
Early versus delayed laparoscopic cholecystectomy after endoscopic retrograde cholangiopancreatography: A meta-analysis
2023, Medicine (United States)

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ArticlesRandomised trial of endoscopic sphincterotomy with gallbladder left in situ versus open surgery for common bileduct calculi in high-risk patients

Abstract

Bailliere's Clin Gastroenterol

Am J Surg

Surgery

Gastroenterology

The current management of common duct stones

Adv Surg

Tratamiento de la coledocolitiasis en el paciente de riesgo elevado

Med Clin (Barc)

The management of common bile duct calculi by endoscopic sphincterotomy in patients with gallbladders 'in situ'

Br J Surg

Endoscopic sphincteromy for common bile duct calculi in patients with gallbladder 'in situ' considered unfit for surgery

Gut

Management of high-risk patients with common bile duct stones and a gallbladder in situ

A surgical or endoscopic approach. Gastroenterology

Endoscopic versus surgical management of common bile duct stones. Short term results of a prospective randomized trial

Hepatology

Study of common bile duct exploration and endoscopic sphincterotomy in a consecutive series of 438 patients

Br J Surg

Surgical versus endoscopic management of common bile duct stones

Ann Surg

Articles
Randomised trial of endoscopic sphincterotomy with gallbladder left in situ versus open surgery for common bileduct calculi in high-risk patients