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NCT Number: NCT07161960

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Chiang Mai University 110 Inthawarorot Road, Sri Phum, Mueang, Chiang Mai 50200, Thailand

Chiang Mai, 50200, Thailand

Location status: Recruiting

Location contact

Yada Suwan, Doctor of Medicine

CONTACT

[email protected]

+66 084-6561191

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laparoscopic cholecystectomy

Procedure

Laparoscopic cholecystectomy is the definite treatment for acute cholecystitis. According to Tokyo Guideline 2018, the proper timing of delay LC remains unclear due to lack to proper evidence.

Primary outcomes

  1. Comprehensive Complication Index from PCC and LC

    Time frame: From enrollment to 3 months postoperative

    Comprehensive Complication Index (CCI)is a score derived from Clavien-Dindo Classification. In this study, the complications include both from Percutaneous Cholecystostomy (PCC) and from Laparoscopic Cholecystectomy (LC). The Clavien-Dindo Classification is ranging from 1 (any deviation from postoperative course) to 5 (death). CCI integrates all CD complications and weights its severity. CCI is ranging from 0 (no complication) to 100 (death).

Secondary outcomes

  1. Nasaar Difficulty Scoring

    Time frame: During the operation

    Nasaar Difficulty Scoring is used to evaluate intraoperative finding of LC difficulty, determining by the surgeons who perform LC. The scores include 3 aspects; gallbladder, cystic pedicle and adhesion. In each aspect, the score is ranging from 1 (the easiest) to 4 (the hardest).

  2. Length of Hospital Stay (LOS)

    Time frame: During enrollment to 3 months postoperative or date that complication resolves

    In the early LC group, LOS refers to the duration that the patients stays in the hospital for the treatment for acute cholecystitis. In the delay LC group, LOS refers to duration of the first admission (admit for PCC insertion), the admission for LC and other admissions that are associated with PCC retention or LC complication.

  3. Rate of Conversion to Open Cholecystectomy

    Time frame: During the operation

  4. Rate of Subtotal Cholecystectomy

    Time frame: During the operation

  5. Incidence of Bile Duct Injury

    Time frame: During the operation to 3 months postoperative

Study contacts

Contact information is provided by the study sponsor or research team.

Yada Suwan, Doctor of Medicine

CONTACT

[email protected]

+66 084-6561191

Sponsors and collaborators

Lead sponsor

Yada Suwan

Other

Collaborators

  • Chiang Mai University
  • Lampang Hospital
  • Maharaj Nakorn Chiang Mai Hospital
  • Phrae Hospital

Registry information

Official study title

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

Acronym: ESCAPE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 9, 2025
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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