Early Versus Delayed Cholecystectomy After Percutaneous Drainage in Moderate and Severe Cholecystitis (ESCAPE Trial)

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Methods: This prospective, randomized controlled trial enrolled patients diagnosed with moderate to severe acute cholecystitis who underwent PCC. Clinical manifestations and laboratory parameters were monitored for 72 hours following PCC insertion. Patients demonstrating clinical or laboratory improvement were subsequently randomized into two groups: early LC and delayed LC. * Early LC group: Laparoscopic cholecystectomy was performed during the same hospitalization. * Delayed LC group: Laparoscopic cholecystectomy was performed more than 6 weeks after PCC insertion. The primary endpoint/outcome is comprehensive complication index (CCI) from PCC and LC. Secondary endpoints include Nasaar Difficulty Scoring, length of hospital stay, rate of subtotal cholecystectomy, rate of conversion to open cholecystectomy and incidence of bile duct injury. Results and Discussion: The results of this study will provide valuable insights into the timing of LC following PCC and may influence future treatment protocols for moderate and severe acute cholecystitis. By assessing the feasibility and safety of early LC after PCC insertion, the ESCAPE trial aims to reduce the burden of PCC-related complications and optimize patient outcomes.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Thailand
Faculty of Medicine, Chiang Mai University 110 Inthawarorot Road, Sri Phum, Mueang, Chiang Mai 50200, Thailand
RECRUITING
Chiang Mai
Contact Information
Primary
Yada Suwan, Doctor of Medicine
yada.suwan@cmu.ac.th
+66 084-6561191
Time Frame
Start Date: 2025-07-01
Estimated Completion Date: 2027-11-01
Participants
Target number of participants: 64
Treatments
Experimental: Early Laparoscopic Cholecystectomy
The patients will undergo laparoscopic cholecystectomy (LC) within the same admission of PCC and after PCC for 72 hours, usually not more than 2 weeks.
Experimental: Delay Laparoscopic Cholecystectomy
The patients will undergo laparoscopic cholecystectomy (LC) after 6 weeks from PCC insertion, avoiding active inflammation and swelling
Sponsors
Leads: Yada Suwan
Collaborators: Chiang Mai University, Lampang Hospital, Phrae Hospital, Maharaj Nakorn Chiang Mai Hospital

This content was sourced from clinicaltrials.gov