NCT07161960 Early Versus Delayed Cholecystectomy After Percutaneous Cholecystostomy in Moderate and Severe Cholecystitis (ESCAPE)

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This trial targets 64 participants in total. It began in 2025-07-01 with a primary completion date of 2027-07-01.

Brief Summary

Abstract: Acute cholecystitis (AC) is typically managed according to the 2018 Tokyo Guidelines, with treatment strategies determined by the severity of the disease, patient comorbidities, and hospital capabilities. In cases of moderate AC, treatment options include antibiotics with delayed laparoscopic cholecystectomy (LC), antibiotics with early LC, or antibiotics with percutaneous cholecystostomy (PCC) followed by delayed LC. However, the Toyo Guideline 2018 suggested that there is a lack of consensus regarding the optimal timing for surgery following PCC due to insufficient scientific evidence. In practice, delayed LC is often performed approximately 6 weeks after PCC insertion. While PCC can serve as a treatment option before definite surgery, complications such as tube dislodgment, obstruction, and failure to ambulate are common, leading to further hospital admissions and increased comorbidities. The ESCAPE trial was conducted to evaluate the optimal timing for LC following PCC in moderate and severe forms of acute cholecystitis, with the goal of improving treatment standards and reducing complications associated with PCC retention. We hypothesize that early LC after PCC insertion will be a feasible and effective alternative. 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 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.

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