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

Wuhan Integrated Traditional Chinese and Western Medicine Hospital

Status: Completed

Conditions: Severe Acute Cholangitis

Treatments: Procedure: Endoscopic Retrograde Cholangiopancreatography; Procedure: Percutaneous Transhepatic Biliary Drainage

Study type: Interventional

Funder types: Other

Identifiers

NCT07064980

IRB-2021-KY027

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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126 participants in 2 patient groups

Experimental Group (ERCP)

Experimental group

Description:

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).

Treatment:

Procedure: Endoscopic Retrograde Cholangiopancreatography

Active Comparator Group (PTBD)

Active Comparator group

Description:

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.

Treatment:

Procedure: Percutaneous Transhepatic Biliary Drainage