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

Wuhan Integrated Traditional Chinese and Western Medicine Hospital126 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

126

Conditions

Severe Acute Cholangitis

Interventions

Endoscopic Retrograde CholangiopancreatographyPROCEDURE

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.

Percutaneous Transhepatic Biliary DrainagePROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Wuhan, Hubei, China

Outcomes

Primary Outcomes

Length of Hospital Stay

The total number of days from hospital admission to discharge.

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

Secondary Outcomes

Time to First Ambulation

Time in days from the procedure until the patient is first able to walk.

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

Procedure Time

Time in minutes from scope insertion/skin puncture to the end of drainage placement.

Time frame: Measured intraoperatively

Time to Return of Bowel Function

Time in hours or days from the procedure until the first flatus or bowel movement.

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

Change in Inflammatory Markers

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).

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

Change in Pain Intensity

Change from baseline in pain severity assessed using the Visual Analog Scale (VAS), scored 0-10.

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

Therapeutic Efficacy

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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.