Comparing Early and Delayed Laparoscopic Gallbladder Removal After Percutaneous Drainage in Moderate to Severe Acute Cholecystitis
Led by Yada Suwan · Updated on 2025-09-25
64
Participants Needed
1
Research Sites
17 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the best timing for laparoscopic cholecystectomy LC after percutaneous cholecystostomy PCC in patients with moderate to severe acute cholecystitis. The study aims to improve treatment standards and reduce complications related to PCC. Currently, delayed LC is often done about 6 weeks after PCC, but this trial compares early LC during the same hospital stay to the usual delayed approach.
Participants are randomly assigned to one of two groups early LC performed within the same admission after PCC insertion, usually within 72 hours but not more than 2 weeks, or delayed LC done more than 6 weeks after PCC to allow inflammation and swelling to subside. The study monitors clinical and laboratory signs for 72 hours after PCC before randomization.
During the study, researchers will track complications from PCC and LC using the Comprehensive Complication Index for up to 3 months after surgery. They will also assess surgical difficulty, hospital stay length, rates of subtotal cholecystectomy, conversion to open surgery, and bile duct injury. Participants undergo laparoscopic surgery at designated hospitals with follow-up to monitor outcomes and safety for several months after procedures.
CONDITIONS
Brief Title
Early Versus Delayed Cholecystectomy After Percutaneous Cholecystostomy in Moderate and Severe Cholecystitis (ESCAPE)
Research Team
Y
Yada Suwan, Doctor of Medicine
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Patients diagnosed with moderate or severe acute cholecystitis according to Tokyo Guideline 2018
Percutaneous cholecystostomy (PCC) performed by body interventionists or surgeons
Laparoscopic cholecystectomy planned at Maharaj Nakorn Chiang Mai Hospital, Lampang Hospital, or Phrae Hospital
Age 20 years or older
You will not qualify if you...
Patients suspected to have common bile duct stones requiring EUS or ERCP
Presence of perihepatic abscess or liver abscess
Patients with active or severe underlying diseases for whom specialists advise postponing surgery
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 6 weeks depending on group assignment
Participants undergo laparoscopic cholecystectomy either early within the same admission after percutaneous cholecystostomy (PCC) usually within 2 weeks, or delayed approximately 6 weeks after PCC to allow inflammation to subside.
1 hospital admission for surgery and recovery
Follow-up
Duration - 3 months postoperative
Participants are monitored for complications and recovery for up to 3 months after surgery.
Approximately 3 to 4 follow-up visits
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Finding the Most Favorable Timing for Cholecystectomy after Percutaneous Cholecystostomy Tube Placement: An Analysis of Institutional and National Data.
Steven G Woodward, Arturo J Rios-Diaz, Richard Zheng...
The choice of operation timing of laparoscopic cholecystectomy (LC) after percutaneous transhepatic gallbladder drainage (PTGBD) for acute cholecystitis: a retrospective clinical analysis.
Urgent versus elective laparoscopic cholecystectomy following percutaneous transhepatic gallbladder drainage for high-risk grade II acute cholecystitis.