NCT07064980

ERCP Versus PTBD for Severe Acute Cholangitis Caused by Bile Duct Stones

Analysis of the Effectiveness and Safety of Endoscopic Retrograde Cholangiopancreatography Versus Percutaneous Transhepatic Biliary Drainage in Severe Acute Cholangitis Caused by Common Bile Duct Stones

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Wuhan Integrated Traditional Chinese and Western Medicine Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, randomized controlled trial designed to compare the effectiveness and safety of endoscopic retrograde cholangiopancreatography (ERCP) with percutaneous transhepatic biliary drainage (PTBD) for the treatment of severe acute cholangitis caused by common bile duct stones. The primary goal is to determine which emergency drainage procedure leads to faster patient recovery, specifically by evaluating the length of hospital stay, without increasing complication rates.

Detailed description

Severe acute cholangitis (AC) due to common bile duct stones is a life-threatening condition requiring urgent biliary decompression. While both ERCP and PTBD are established minimally invasive options, the optimal choice remains under discussion. This single-center, prospective, randomized controlled trial was conducted to compare these two interventions. A total of 126 patients with severe AC (Tokyo Guidelines 2018 Grade II or III) were randomized to either the ERCP group (n=63) or the PTBD group (n=63). Randomization was performed using a computer-generated sequence with concealed allocation. While operators could not be blinded, outcome assessors and data analysts were. The study hypothesis is that ERCP, as a more direct route for potential stone removal and drainage, may facilitate a quicker overall recovery compared to PTBD. The trial evaluates procedural outcomes, recovery metrics, therapeutic efficacy, inflammatory markers, and safety profiles to provide evidence for clinical decision-making.

Conditions

• Severe Acute Cholangitis

Interventions

Type	Name	Description
PROCEDURE	Endoscopic Retrograde Cholangiopancreatography	Performed under intravenous anesthesia. A duodenoscope was advanced to the major duodenal papilla. After cannulation and cholangiography, purulent bile was aspirated. Biliary sphincterotomy was performed in most patients (95.2%), followed by stone extraction using a balloon catheter or basket. A 7-10 Fr nasobiliary tube was placed for drainage in all patients. Prophylactic rectal indomethacin (100mg) was also administered.
PROCEDURE	Percutaneous Transhepatic Biliary Drainage	Performed under general anesthesia with endotracheal intubation and ultrasound guidance. An 18G needle was used to puncture a dilated intrahepatic bile duct. After guidewire placement, an 8-10 Fr drainage catheter was inserted for either internal-external drainage (if the guidewire could pass into the duodenum) or purely external biliary drainage.

Timeline

• Start date: 2021-05-01
• Primary completion: 2024-05-31
• Completion: 2024-05-31
• First posted: 2025-07-15
• Last updated: 2025-07-15

Locations

1 site across 1 country: China