CompletedNot Applicable

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

China126 participantsStarted 2021-05-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. *…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Length of Hospital Stay

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

Trial details

NCT IDNCT07064980

SponsorWuhan Integrated Traditional Chinese and Western Medicine Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-31

View on ClinicalTrials.gov More Severe Acute Cholangitis trials