Early versus delayed gallbladder removal after tube drainage for moderate or severe acute cholecystitis.
Official title: Early Versus Delayed Cholecystectomy After Percutaneous Drainage in Moderate and Severe Cholecystitis (ESCAPE Trial)
Run by Chiang Mai University · NCT07161960 · Data updated 2026-11-12
This trial tests whether removing the gallbladder soon after a drainage tube is placed or waiting several weeks leads to fewer complications for adults with moderate or severe acute cholecystitis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years and up |
| Sex | All |
| Enrollment | 64 (estimated) |
| Sponsor | Chiang Mai University Academic / other |
| Locations | 1 site (Chiang Mai) |
| Status | Recruiting |
| Started | July 1, 2025 |
| Main results expected | July 1, 2027 |
| Study ends | November 1, 2027 |
| Registry record updated | September 25, 2025 |
| Trial ID | NCT07161960 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 20 or older with moderate or severe acute cholecystitis who received percutaneous cholecystostomy and are eligible for laparoscopic cholecystectomy at the participating hospitals.
✕Probably not a fit
Patients with suspected common bile duct stones needing ERCP, perihepatic or liver abscess, or severe active medical conditions that make surgery unsafe are unlikely to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults (age ≥20) with moderate or severe acute cholecystitis who have had a percutaneous cholecystostomy at one of three hospitals in northern Thailand are enrolled. The protocol compares outcomes for patients who undergo early laparoscopic cholecystectomy versus those who have delayed surgery following initial drainage. Patients with suspected common bile duct stones requiring ERCP, perihepatic or liver abscess, or severe active comorbidities are excluded. Main outcomes include procedure-related complications, tube-related problems, hospital readmissions, and overall recovery.
Why it matters
Potential benefit: If successful, the results could identify the safest timing for gallbladder removal after drainage and reduce tube-related complications and unplanned readmissions.
How similar studies have gone: Existing evidence on optimal timing after percutaneous cholecystostomy is limited and inconsistent, and current guidelines note a lack of consensus.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * The patients are diagnosed moderate or severe from of acute cholecystitis according to Tokyo Guideline 2018. * PCC insertion was performed by body interventionists or surgeons. * Laparoscopic cholecystectomy will be performed in Maharaj Nakorn Chiang Mai Hospital, Lampang Hospital and Phrae Hospital. * Age equal or more than 20 years-old Exclusion Criteria: * The patients that suspected CBD stone and need to undergo EUS / ERCP. * Coincidence perihepatic abscess or liver abscess * The patients with active or severe underlying disease, whom specialists suggest to postpone an operation.
Where it's running
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Faculty of Medicine, Chiang Mai University 110 Inthawarorot Road, Sri Phum, Mueang, Chiang Mai 50200, Thailand
Chiang Mai, Thailand Recruiting
Study contacts
- Study coordinator: Yada Suwan, Doctor of Medicine
- Email: yada.suwan@cmu.ac.th
- Phone: +66 084-6561191
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.