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

NCT07064980 | Completed

• 1 other identifier: IRB-2021-KY027
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Acute Cholangitis

Keywords

Endoscopic retrograde cholangiopancreatography; Percutaneous transhepatic biliary drainage; Severe Acute Cholangitis; Common Bile Duct Stones

Outcome Measures

Primary Outcomes (1)

• Length of Hospital Stay

  The total number of days from hospital admission to discharge.

  At hospital discharge (up to approximately 3-4 weeks post-procedure).

Secondary Outcomes (7)

• Time to First Ambulation

  From date of procedure until hospital discharge (estimated maximum of 4 weeks).

• Procedure Time

  Measured intraoperatively

• Time to Return of Bowel Function

  From date of procedure until hospital discharge (estimated maximum of 4 weeks).

• Change in Inflammatory Markers

  Baseline (pre-treatment), 72 hours post-procedure, and 3 months post-treatment.

• Change in Pain Intensity

  Baseline (pre-treatment), 72 hours post-procedure, and 3 months post-treatment.

Study Arms (2)

Experimental Group (ERCP)

EXPERIMENTAL

Patients assigned to this arm underwent endoscopic retrograde cholangiopancreatography (ERCP). After intravenous anesthesia, a duodenoscope was advanced to the major duodenal papilla. The bile duct was cannulated, and common bile duct stones were extracted using a basket or balloon, typically following a biliary sphincterotomy. A nasobiliary tube was placed for drainage. All patients in this group received prophylactic rectal indomethacin (100mg).

Procedure: Endoscopic Retrograde Cholangiopancreatography

Active Comparator Group (PTBD)

ACTIVE COMPARATOR

Patients assigned to this arm underwent percutaneous transhepatic biliary drainage (PTBD). Under general anesthesia and ultrasound guidance, a dilated intrahepatic bile duct was punctured. A guidewire was passed into the biliary system, followed by the placement of an 8-10 Fr drainage catheter for either internal-external or purely external biliary drainage.

Procedure: Percutaneous Transhepatic Biliary Drainage

Interventions

Endoscopic Retrograde Cholangiopancreatography PROCEDURE

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.

Experimental Group (ERCP)

Percutaneous Transhepatic Biliary Drainage PROCEDURE

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.

Active Comparator Group (PTBD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wuhan Integrated Traditional Chinese and Western Medicine Hospital: lead

Study Sites (1)

Wuhan No.1 Hospital (Wuhan Hospital of Traditional Chinese & Western Medicine)

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 15, 2025
• Study Start: May 1, 2021
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: July 15, 2025

Record last verified: 2025-07

Locations

CN (1)