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

NCT07161960 | Recruiting

• 1 other identifier: SUR-2568-0197
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Cholecystitis; Percutaneous Cholecystostomy; Laparoscopic Cholecystectomy

Keywords

Acute cholecystitis; Percutaneous cholecystostomy; Laparoscopic cholecystectomy; Early LC; Delay LC

Outcome Measures

Primary Outcomes (1)

• Comprehensive Complication Index from PCC and LC

  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).

  From enrollment to 3 months postoperative

Secondary Outcomes (5)

• Nasaar Difficulty Scoring

  During the operation

• Length of Hospital Stay (LOS)

  During enrollment to 3 months postoperative or date that complication resolves

• Rate of Conversion to Open Cholecystectomy

  During the operation

• Rate of Subtotal Cholecystectomy

  During the operation

• Incidence of Bile Duct Injury

  During the operation to 3 months postoperative

Study Arms (2)

Early Laparoscopic Cholecystectomy

EXPERIMENTAL

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.

Procedure: Laparoscopic cholecystectomy

Delay Laparoscopic Cholecystectomy

EXPERIMENTAL

The patients will undergo laparoscopic cholecystectomy (LC) after 6 weeks from PCC insertion, avoiding active inflammation and swelling

Procedure: Laparoscopic cholecystectomy

Interventions

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.

Delay Laparoscopic Cholecystectomy; Early Laparoscopic Cholecystectomy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yada Suwan: lead
• Chiang Mai University: collaborator
• Lampang Hospital: collaborator
• Phrae Hospital: collaborator
• Maharaj Nakorn Chiang Mai Hospital: collaborator

Study Sites (1)

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

Chiang Mai, 50200, Thailand

RECRUITING

Related Publications (6)

• Yamazaki S, Shimizu A, Kubota K, Notake T, Yoshizawa T, Masuo H, Sakai H, Hosoda K, Hayashi H, Yasukawa K, Umemura K, Kamachi A, Goto T, Tomida H, Seki H, Shimura M, Soejima Y. Urgent versus elective laparoscopic cholecystectomy following percutaneous transhepatic gallbladder drainage for high-risk grade II acute cholecystitis. Asian J Surg. 2023 Jan;46(1):431-437. doi: 10.1016/j.asjsur.2022.05.046. Epub 2022 May 21.

  PMID: 35610148 RESULT

• Woodward SG, Rios-Diaz AJ, Zheng R, McPartland C, Tholey R, Tatarian T, Palazzo F. Finding the Most Favorable Timing for Cholecystectomy after Percutaneous Cholecystostomy Tube Placement: An Analysis of Institutional and National Data. J Am Coll Surg. 2021 Jan;232(1):55-64. doi: 10.1016/j.jamcollsurg.2020.10.010. Epub 2020 Oct 21.

  PMID: 33098966 RESULT

• Okamoto K, Suzuki K, Takada T, Strasberg SM, Asbun HJ, Endo I, Iwashita Y, Hibi T, Pitt HA, Umezawa A, Asai K, Han HS, Hwang TL, Mori Y, Yoon YS, Huang WS, Belli G, Dervenis C, Yokoe M, Kiriyama S, Itoi T, Jagannath P, Garden OJ, Miura F, Nakamura M, Horiguchi A, Wakabayashi G, Cherqui D, de Santibanes E, Shikata S, Noguchi Y, Ukai T, Higuchi R, Wada K, Honda G, Supe AN, Yoshida M, Mayumi T, Gouma DJ, Deziel DJ, Liau KH, Chen MF, Shibao K, Liu KH, Su CH, Chan ACW, Yoon DS, Choi IS, Jonas E, Chen XP, Fan ST, Ker CG, Gimenez ME, Kitano S, Inomata M, Hirata K, Inui K, Sumiyama Y, Yamamoto M. Tokyo Guidelines 2018: flowchart for the management of acute cholecystitis. J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):55-72. doi: 10.1002/jhbp.516. Epub 2017 Dec 20.

  PMID: 29045062 RESULT

• Molavi I, Schellenberg A, Christian F. Clinical and operative outcomes of patients with acute cholecystitis who are treated initially with image-guided cholecystostomy. Can J Surg. 2018 Jun;61(3):195-199. doi: 10.1503/cjs.003517.

  PMID: 29806817 RESULT

• Bao J, Wang J, Shang H, Hao C, Liu J, Zhang D, Han S, Li Z. The choice of operation timing of laparoscopic cholecystectomy (LC) after percutaneous transhepatic gallbladder drainage (PTGBD) for acute cholecystitis: a retrospective clinical analysis. Ann Palliat Med. 2021 Aug;10(8):9096-9104. doi: 10.21037/apm-21-1906.

  PMID: 34488395 RESULT

• Lyu Y, Li T, Wang B, Cheng Y. Early laparoscopic cholecystectomy after percutaneous transhepatic gallbladder drainage for acute cholecystitis. Sci Rep. 2021 Jan 28;11(1):2516. doi: 10.1038/s41598-021-82089-4.

  PMID: 33510242 RESULT

MeSH Terms

Conditions

Cholecystitis, Acute

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cholecystectomy; Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures

Central Study Contacts

Yada Suwan, Doctor of Medicine

CONTACT

+66 084-6561191; yada.suwan@cmu.ac.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Yada Suwan, Doctor of Medicine

Study Record Dates

• First Submitted: August 31, 2025
• First Posted: September 9, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)