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

NCT ID: NCT07064980

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2024-05-31

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.

Conditions

Severe Acute Cholangitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental Group (ERCP)

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).

Group Type: EXPERIMENTAL

Endoscopic Retrograde Cholangiopancreatography

Intervention Type: 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.

Active Comparator Group (PTBD)

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.

Group Type: ACTIVE_COMPARATOR

Percutaneous Transhepatic Biliary Drainage

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wuhan Integrated Traditional Chinese and Western Medicine Hospital

OTHER

Sponsor Role: lead

Responsible Party

Liping Zhu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Wuhan, Hubei, China

Countries

China

Other Identifiers

IRB-2021-KY027

Identifier Type: -

Identifier Source: org_study_id