ETGBD in Surgically Unfit Patients With Both Choledocholithiasis and Cholecystolithiasis

Completed

• Conditions: Efficacy

• Registration Number: NCT05935969
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Cholecystectomy is recommended for patients with both gallbladder (GB) and common bile duct (CBD) stones to prevent recurrent biliary complications, unless there are specific reasons for surgery is considered inappropriate. The aim of this study was to evaluate the role of transpapillary gallbladder stent placement in surgically unfit patients with both CBD stone and gallstone.

Detailed Description

Gallstones affect 10-15% of the adult population, and 10-25% of them may develop biliary pain or complications. Patients with symptomatic gallstones often have a concomitant CBD stone in 10-20% of them. Most gallstones do not require invasive treatment due to their benign natural history, but CBD stones should be removed due to the risk of developing gallstone-related complications such as obstructive cholangitis and acute gallstone pancreatitis. CBD stones result mainly from the migration of gallstones into the bile duct, so the gold standard treatment for gallstones with CBD stones is endoscopic removal of the CBD stone followed by cholecystectomy to prevent recurrent biliary complications, such as calculous cholangitis or acute cholecystitis.

However, patients who were ineligible for surgery due to high-risk conditions, including the elderly, critically ill status, and severe underlying morbidities, may not get the chance to undergo cholecystectomy. Initial nonoperative management with delayed cholecystectomy has been considered as an alternative treatment, but laparoscopic cholecystectomy reduces the rate of major complications compared with percutaneous gallbladder drainage, even in high-risk patients, and outcomes after early laparoscopic cholecystectomy in octogenarians are comparable to younger patients. Despite this evidence, there are still debates among experts for optimal treatment methods for high-risk patients for surgery with symptomatic CBD stone with gallstone, and gallbladder drainage therapy first to perform for stabilization with surgery rather than urgent cholecystectomy in real practice. Therefore, there is still an unmet need for how to prevent recurrence of CBD stones in patients with concomitant gallstones after endoscopic removal of CBD stones.

Nonsurgical cholecystic drainage methods, including percutaneous transhepatic gallbladder drainage (PTGBD), endoscopic ultrasound-guided gallbladder drainage (EUS-GBD), and endoscopic transpapillary gallbladder drainage (ETGBD), have been introduced and actively used as a bridge or alternative therapy in patients at high risk for surgery. Several studies have reported the results of its feasibility and efficacy, mainly focusing on the management of patients with acute cholecystitis. However, the evidence for appropriate management considering non-surgical treatments for patients with both CBD stones and gallstones is still limited. This study evaluated the feasibility and efficacy of ETGBD for patients with both CBD stone and gallstones to prevent recurrent biliary complications in patients at high risk for surgery.

Study Timeline

• Study Start: 2022-08-01
• Primary Completion: 2023-03-01
• Study Completion: 2023-05-01
• Study First Submitted: 2023-06-27
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-05
• Last Update Submitted: 2023-07-05
• Study First Posted: 2023-07-07
• Last Update Posted: 2023-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 302

Inclusion Criteria

(i) age ≥20 years (ii) presence of choledocolithiasis and cholecystolithiasis on imaging studies (iii) surgically unfit for cholecystectomy.

Exclusion Criteria

(i) presence of malignant biliary obstruction (ii) follow-up of less than 1 month (iii) previous EST status (iv) pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence of biliary complications	through study completion, an average of 2 year	The primary outcome measures were biliary complications, including acute cholecystitis, acute cholangitis, recurrence of choledocolithiasis, and biliary colic. The diagnosis of acute cholangitis, acute cholecystitis were based on Tokyo guideline 18.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of