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

Not Applicable

Completed

• Conditions: Severe Acute Cholangitis

• Registration Number: NCT07064980
• Lead Sponsor: Wuhan Integrated Traditional Chinese and Western Medicine Hospital

Brief 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.

Study Timeline

• Study Start: 2021-05-01
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31
• Status Verified: 2025-07
• Study First Submitted: 2025-07-01
• Study First Submitted QC: 2025-07-13
• Last Update Submitted: 2025-07-13
• Study First Posted: 2025-07-15
• Last Update Posted: 2025-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

• Patients who met the diagnostic criteria for acute cholangitis according to the Tokyo Guidelines 2018 (TG18), and were diagnosed through physical examination, ultrasound, CT, or MRCP showing common bile duct stones as the cause of obstruction.
• Body temperature <36°C or >38°C.
• Presence of jaundice or signs of organ dysfunction (e.g., hypotension responsive to fluids for Grade II, or requiring vasopressors for Grade III, altered mental status, etc.).
• Patients who signed informed consent.

Exclusion Criteria

• Patients with concurrent diseases such as gastric perforation or active gastrointestinal bleeding unrelated to cholangitis.
• Patients with acute pancreatitis as the primary diagnosis.
• Patients with serious primary diseases in the heart, brain, lungs, kidneys, hematopoietic, or nervous systems contraindicating either procedure.
• Pregnant or breastfeeding women.
• Patients with cognitive dysfunction unable to provide consent.
• Known pancreatobiliary malignancy as the cause of obstruction.
• Severe liver cirrhosis (Child-Pugh C) or liver atrophy.
• Patients with severe systemic primary diseases, who could not tolerate the anesthesia or procedure.
• Patients with mental disorders, hematologic diseases (e.g., severe coagulopathy uncorrectable pre-procedure), autoimmune diseases directly impacting biliary system, or those using high-dose corticosteroids affecting inflammatory markers.
• Patients participating in other clinical drug trials.
• Previous ERCP or PTBD for the current episode of cholangitis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Length of Hospital Stay	At hospital discharge (up to approximately 3-4 weeks post-procedure).	The total number of days from hospital admission to discharge.

Secondary Outcome Measures

Name	Time	Method
Time to First Ambulation	From date of procedure until hospital discharge (estimated maximum of 4 weeks).	Time in days from the procedure until the patient is first able to walk.
Procedure Time	Measured intraoperatively	Time in minutes from scope insertion/skin puncture to the end of drainage placement.
Time to Return of Bowel Function	From date of procedure until hospital discharge (estimated maximum of 4 weeks).	Time in hours or days from the procedure until the first flatus or bowel movement.
Therapeutic Efficacy	Assessed at 24 hours post-procedure.	Assessed as Significant Effect, Effective, or Ineffective based on resolution of biliary obstruction and clinical symptoms within 24 hours. The total effective rate is calculated as (Significant + Effective) / Total cases.
Change in Inflammatory Markers	Baseline (pre-treatment), 72 hours post-procedure, and 3 months post-treatment.	Change from baseline in serum levels of Interleukin-6 (IL-6), Interleukin-1 (IL-1), Tumor Necrosis Factor-alpha (TNF-α), and C-reactive protein (CRP).
Change in Pain Intensity	Baseline (pre-treatment), 72 hours post-procedure, and 3 months post-treatment.	Change from baseline in pain severity assessed using the Visual Analog Scale (VAS), scored 0-10.
Incidence of Complications	up to 3 months post-procedure.	Number of participants experiencing adverse events, including post-ERCP pancreatitis, abdominal infection, gastrointestinal bleeding, bile leakage, liver damage, and procedure-specific complications.

Trial Locations

Locations (1)

Wuhan No.1 Hospital (Wuhan Hospital of Traditional Chinese & Western Medicine); 🇨🇳 Wuhan, Hubei, China