Urgent versus elective laparoscopic cholecystectomy following percutaneous transhepatic gallbladder drainage for high-risk grade II acute cholecystitis.
Shiori Yamazaki, Akira Shimizu, Koji Kubota...
https://pubmed.ncbi.nlm.nih.gov/35610148Actively Recruiting
Phase Not Applicable
Age: 20Years +
All Genders
ID07161960
Early Versus Delayed Cholecystectomy After Percutaneous Drainage in Moderate and Severe Cholecystitis (ESCAPE Trial)
Led by Yada Suwan · Updated on 2025-09-25
64
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
Y
Yada Suwan
Lead Sponsor
C
Chiang Mai University
Collaborating Sponsor
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)
Who Can Participate
Age: 20Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
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
Trial Site Locations
Total: 1 location
1
Faculty of Medicine, Chiang Mai University 110 Inthawarorot Road, Sri Phum, Mueang, Chiang Mai 50200, Thailand
Chiang Mai, Thailand, 50200
Actively Recruiting
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Research Team
Y
Yada Suwan, Doctor of Medicine
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...
https://pubmed.ncbi.nlm.nih.gov/33098966Tokyo Guidelines 2018: flowchart for the management of acute cholecystitis.
Kohji Okamoto, Kenji Suzuki, Tadahiro Takada...
https://pubmed.ncbi.nlm.nih.gov/29045062Clinical and operative outcomes of patients with acute cholecystitis who are treated initially with image-guided cholecystostomy.
Ida Molavi, Angela Schellenberg, Francis Christian
https://pubmed.ncbi.nlm.nih.gov/29806817The choice of operation timing of laparoscopic cholecystectomy (LC) after percutaneous transhepatic gallbladder drainage (PTGBD) for acute cholecystitis: a retrospective clinical analysis.
Jianheng Bao, Jianxiong Wang, Haitao Shang...
https://pubmed.ncbi.nlm.nih.gov/34488395Early laparoscopic cholecystectomy after percutaneous transhepatic gallbladder drainage for acute cholecystitis.
Yunxiao Lyu, Ting Li, Bin Wang...
https://pubmed.ncbi.nlm.nih.gov/33510242