Endoscopic Sphincterotomy With or Without Cholecystectomy for Choledocholithiasis in High Risk Surgical Patients: A Decision Analysis

Abstract

Background: Laparoscopic cholecystectomy (LC) is recommended for patients with choledocholithiasis after ERCP with endoscopic sphincterotomy (ES) and stone extraction in order to prevent cholecystitis, biliary obstruction, and infection. However patients at increased risk of surgical complications may fare better with ES alone. We designed a decision model to address whether ES alone versus ES followed by LC (ES + LC) is the optimal treatment modality in high-risk patients with choledocholithiasis. Methods: The base-case cohort comprised individuals age 70-79 with obstructive jaundice who have undergone a successful ERCP with ES and biliary clearance. Recurrent biliary complications over a 2-year period stratified by gallbladder status (in/out) and age-stratified surgical complication rates were obtained from the literature. Failure of therapy was defined as either recurrent symptoms or death attributed to a biliary complication. Multiple one-way and multi-way sensitivity analyses were performed to determine the patient ages and threshold complication rates that would alter treatment strategies. Results: Under base case assumptions, ES failed in 14% whereas ES + LC failed in 18% of cases, favoring ES alone as the dominant strategy in patients age 70-79. Mortality in the EC + LC group was 3.4 times that of the ES alone cohort. Sensitivity analysis determined a threshold surgical complication rate of 8.7%, above which ES was the dominant strategy. For the cohort of age 80+, ES was dominant with an incremental success rate of 8% over ES + LC. Three-way sensitivity analysis of recurrent complications in ES, ES + LC and surgical morbidity, identified ES as the dominant strategy in all cases except when biliary complications for ES exceeded 22.2% (range 6-24%). Mortality in the ES + LC was 7.6 times that of the ES cohort. For age < 70, ES + LC was the dominant strategy with an incremental success rate 5% compared to ES. Sensitivity analysis in this group identified a threshold surgical complication rate of 9.8%, above which ES was the dominant strategy. Conclusions: 1) Management of choledocholithiasis by ERCP with sphincterotomy and stone clearance, but without cholecystectomy, should be strongly considered for patients aged 70-79. 2) In patients age 80 and above, ERCP alone is the dominant strategy, largely due to increased surgical complication rates. 3) For low-risk patients, laparoscopic cholecystectomy should be performed to prevent recurrent biliary complications. Background: Laparoscopic cholecystectomy (LC) is recommended for patients with choledocholithiasis after ERCP with endoscopic sphincterotomy (ES) and stone extraction in order to prevent cholecystitis, biliary obstruction, and infection. However patients at increased risk of surgical complications may fare better with ES alone. We designed a decision model to address whether ES alone versus ES followed by LC (ES + LC) is the optimal treatment modality in high-risk patients with choledocholithiasis. Methods: The base-case cohort comprised individuals age 70-79 with obstructive jaundice who have undergone a successful ERCP with ES and biliary clearance. Recurrent biliary complications over a 2-year period stratified by gallbladder status (in/out) and age-stratified surgical complication rates were obtained from the literature. Failure of therapy was defined as either recurrent symptoms or death attributed to a biliary complication. Multiple one-way and multi-way sensitivity analyses were performed to determine the patient ages and threshold complication rates that would alter treatment strategies. Results: Under base case assumptions, ES failed in 14% whereas ES + LC failed in 18% of cases, favoring ES alone as the dominant strategy in patients age 70-79. Mortality in the EC + LC group was 3.4 times that of the ES alone cohort. Sensitivity analysis determined a threshold surgical complication rate of 8.7%, above which ES was the dominant strategy. For the cohort of age 80+, ES was dominant with an incremental success rate of 8% over ES + LC. Three-way sensitivity analysis of recurrent complications in ES, ES + LC and surgical morbidity, identified ES as the dominant strategy in all cases except when biliary complications for ES exceeded 22.2% (range 6-24%). Mortality in the ES + LC was 7.6 times that of the ES cohort. For age < 70, ES + LC was the dominant strategy with an incremental success rate 5% compared to ES. Sensitivity analysis in this group identified a threshold surgical complication rate of 9.8%, above which ES was the dominant strategy. Conclusions: 1) Management of choledocholithiasis by ERCP with sphincterotomy and stone clearance, but without cholecystectomy, should be strongly considered for patients aged 70-79. 2) In patients age 80 and above, ERCP alone is the dominant strategy, largely due to increased surgical complication rates. 3) For low-risk patients, laparoscopic cholecystectomy should be performed to prevent recurrent biliary complications.