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

Official title

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

Overview

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.

Interventions

• Procedure Laparoscopic cholecystectomy
  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 outcome measures

• Comprehensive Complication Index from PCC and LC [Time frame: From enrollment to 3 months postoperative]

Secondary outcome measures (5)

• Nasaar Difficulty Scoring [Time frame: During the operation]
• Length of Hospital Stay (LOS) [Time frame: During enrollment to 3 months postoperative or date that complication resolves]
• Rate of Conversion to Open Cholecystectomy [Time frame: During the operation]
• Rate of Subtotal Cholecystectomy [Time frame: During the operation]
• Incidence of Bile Duct Injury [Time frame: During the operation to 3 months postoperative]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Thailand · 1 center

• Faculty of Medicine, Chiang Mai University 110 Inthawarorot Road, Sri Phum, Mueang, Chiang — Chiang Mai

Publications

• 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.2022.05.04 PMID 35610148
• 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
• 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 PMID 29045062
• 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
• 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
• 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

Identifiers

NCT: NCT07161960 · SUR-2568-0197

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗