NCT07161960: ESCAPE

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

Recruiting now NA Last updated 25 September 2025

What this trial tests

NA trial testing Laparoscopic cholecystectomy in Acute Cholecystitis in 64 participants. Currently enrolling.

Timeline

1 July 2025

Primary endpoint
1 July 2027

1 November 2027

Quick facts

Lead sponsor	Yada Suwan
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	64
Start date	1 July 2025
Primary completion	1 July 2027
Estimated completion	1 November 2027
Sites	1 location across Thailand

Drugs / interventions tested

• Laparoscopic cholecystectomy

Conditions studied

• Acute Cholecystitis — all drugs for Acute Cholecystitis →
• Percutaneous Cholecystostomy — all drugs for Percutaneous Cholecystostomy →
• Laparoscopic Cholecystectomy — all drugs for Laparoscopic Cholecystectomy →

Sponsor

Yada Suwan

Who can join

20 and older, any sex, with Acute Cholecystitis or Percutaneous Cholecystostomy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.