NCT03754491: ERCP

The Comparisons of One-stage Stone Removal in Mild and Moderate Cholangitis

Completed NA Last updated 8 April 2021

What this trial tests

NA trial testing One stage treatment for mild and moderate cholangitis with choledocholithiasis in Cholangitis; Choledocholithiasis in 196 participants. Completed in 31 March 2020.

Timeline

1 October 2018

Primary endpoint
14 February 2020

31 March 2020

Quick facts

Lead sponsor	Chang Gung Memorial Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	196
Start date	1 October 2018
Primary completion	14 February 2020
Estimated completion	31 March 2020
Sites	1 location across Taiwan

Drugs / interventions tested

• One stage treatment for mild and moderate cholangitis with choledocholithiasis

Conditions studied

• Cholangitis; Choledocholithiasis — all drugs for Cholangitis; Choledocholithiasis →

Sponsor

Chang Gung Memorial Hospital

Who can join

Adults 18 to 90, any sex, with Cholangitis; Choledocholithiasis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In expert comment, performing the sphincterotomy for choledocholithiasis with acute cholangitis may increase bleeding and pancreatitis risks (from 2% to 10%). Therefore, investigators often perform biliary drainage in acute stage, and arrange 2nd session ERCP for stone removal later. However, in the recent study, single-stage endoscopic treatment may be still effective (stone removal rate 90%) and safe for mild to moderate acute cholangitis associated with choledocholithiasis. Investigators will carry out a prospective trial to analyze one-stage retrograde endoscopic common bile duct stone removal in mild and moderate cholangitis with choledocholithiasis to determine the safety, successful rate, and complications in these two groups.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Early and Direct Endoscopic Stone Removal in the Moderate Grade of Acute Cholangitis with Choledocholithiasis Was Safe and Effective: A Prospective Study.
   Liang CM, Chiu YC, Lu LS, Wu CK, et al · · 2022 · cited 4× · PMID 36556365 · DOI 10.3390/life12122000
2. Optimal Timing of Single-Stage Retrograde Endoscopic Common Bile Duct Stone Removal in Mild and Moderate Acute Cholangitis: A Prospective Trial
   Liang C, Chiu Y, Lu L, Wu C, et al · · 2020 · cited 1× · DOI 10.21203/rs.3.rs-26612/v1