OGBN P06 Expectant Management Following Endoscopic Sphincterotomy for Choledocholithiasis: Is It Safe?
Authors: Kumaran Naren , Krishnan Arya , Tanner Nicola 
Published: December 2022

Abstract

Background
Gallstone disease is one of the most common gastrointestinal conditions in the UK. It is estimated that 10–15% of adults in the UK have gallstones. Most gallstones are found in the gallbladder but sometimes they can pass through the cystic duct into the common bile duct (CBD) causing choledocholithiasis. CBD stones may present with symptoms of jaundice, cholangitis, pancreatitis or be asymptomatic. Endoscopic sphincterotomy (ES), first reported in 1974, is considered a safe and effective method for managing choledocholithiasis. A significant proportion of patients who undergo ES for symptomatic CBD stones are subsequently referred for cholecystectomy. However, it is unclear whether cholecystectomy itself is necessary after endoscopic CBD stone removal. Some studies recently have indicated that cholecystectomy may not always be needed following endoscopic duct clearance (expectant management), especially for patients that remain asymptomatic or decline surgery (due to frailty, significant comorbidities or patient choice). The primary aim of this study was to assess the outcomes of patients who had expectant management (EM) after endoscopic CBD stone removal.

Methods
We retrospectively analysed the records of patients who underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) in a UK District General Hospital between 01 January 2019 and 31 December 2019. Inclusion criteria were a) presence of CBD stones, and b) patients who underwent ERCP without prior cholecystectomy. The following patients were excluded: a) previous cholecystectomy, b) patients who underwent ERCP for other biliary pathologies, including malignancy. The original data set was obtained from the clinical coding department. ERCP reports, clinic letters, discharge summaries and the hospital results reporting systems were reviewed to extract patient data including demographics, comorbidities, management decision following ERCP, need for repeat ERCP and readmission rate.

Results
A total of 220 patients underwent ERCP in 2019. After excluding patients who did not fit the inclusion criteria,106 patients were included in this study. The median age was 75 years (22–97). 60 patients were women and 46 were men. Median follow up period was 36 months (30–42), excluding patients who died within the follow up period. 63 (59%) patients had a course of expectant management following ERCP for choledocholithiasis while 43 (41%) had a planned cholecystectomy (CS). Of the sixty-three patients who had EM, 40 were considered unfit for surgery, 18 were asymptomatic following ERCP, 3 did not wish to have surgery and the reason is unknown in 2. The median age for EM patients was 80 years (22–91), whereas the CS group had a median age of 62 years (25–82). In the EM group, 11 patients passed away within the follow-up period, none related to biliary pathology. Of the remaining 52 patients, only 1 proceeded to have cholecystectomy during the 3 year follow-up period due to multiple episodes of cholangitis. 2 out of 52 (4%) were readmitted with biliary complications but they continued to be managed conservatively due to frailty.

Conclusions
Endoscopic sphincterotomy and clearance of ductal stones followed by cholecystectomy is the most common treatment for choledocholithiasis. Recent NICE guidelines recommend CS for all patients with symptomatic or asymptomatic CBD stones. However, there is minimal evidence regarding the safety of leaving the gallbladder in situ after ES and thus the issue remains debatable. The majority of studies that have evaluated the complication rates of EM have focused only on elderly patients (age&gt;80years), whereas our study has evaluated all patients after ERCP regardless of age and comorbidities. Pancreatitis did not occur during follow-up in any patients without cholecystectomy. This is in keeping with previous evidence as ES may in itself be definitive in prophylaxis against pancreatitis as it decreases the risk of pancreatic duct obstruction. The majority of patients (95%) with choledocholithiasis who did not undergo cholecystectomy after ERCP remained asymptomatic, indicating that expectant management is safe. However, we recognise this was a single centre study with limited patient numbers and medium-term follow-up. We suggest that future randomized controlled trials be multicentre and should include an assessment of patients’ quality of life and non-hospital managed symptoms.