ERCP Versus PTBD for Severe Acute Cholangitis Caused by Bile Duct Stones (NCT07064980) | Clinical Trial Compass
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 range18 Years
SexALL
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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.
*…
What they're measuring
1
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