Timing of CHolecystectomy In Severe PAncreatitis

NCT06113419 | Recruiting DMC

• 2 other identifiers: 2022-26-02BDVO005 2456-CV1683
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to compare outcomes for interval or early laparoscopic cholecystectomy in patients with moderately severe and severe pancreatitis. The main question\[s\] it aims to answer are:

• To establish whether there is a difference in surgical outcomes comparing patients diagnosed with severe or moderately severe pancreatitis on which early cholecystectomy was performed versus performing interval cholecystectomy.
• The primary endpoint will be to evaluate major complications, defined as a Clavien-Dindo score greater than or equal to III/V.
• Secondary endpoints include evaluating minor complications (defined as a Clavien-Dindo score below III/V), biliary disease recurrence, mortality, postoperative hospital stay and postoperative admittance into an intensive care unit. Participants will be randomly assigned to either group: early cholecystectomy during the pancreatitis hospitalization or interval cholecystectomy scheduled 4 weeks after clinical resolution of pancreatitis.

Conditions

Acute Pancreatitis; Cholelithiasis

Keywords

cholecystectomy; Acute Pancreatitis; Cholelithiasis

Outcome Measures

Primary Outcomes (3)

• Major complications (rates)

  Clavien-Dindo score III in patients with moderately severe and severe acute pancreatitis of biliary origin taken to early vs interval cholecystectomy

  90 days

• Major complications (rates)

  Clavien-Dindo score IV in patients with moderately severe and severe acute pancreatitis of biliary origin taken to early vs interval cholecystectomy

  90 days

• Major complications (rates)

  Clavien-Dindo score V in patients with moderately severe and severe acute pancreatitis of biliary origin taken to early vs interval cholecystectomy

  90 days

Secondary Outcomes (5)

• Recurrence (rates)

  90 days

• Mortality (rates)

  90 days

• Postoperative hospital stay length (days; median)

  90 days

• Minor complications (rates)

  90 days

• Postoperative stay length in the ICU (days; median)

  90 days

Study Arms (2)

Early cholecystectomy

EXPERIMENTAL

Early laparoscopic cholecystectomy (within 72 hours after randomization)

Procedure: Laparoscopic cholecystectomy

Interval cholecystectomy

ACTIVE COMPARATOR

Interval laparoscopic cholecystectomy (30 +/- 5 days after randomization).

Procedure: Laparoscopic cholecystectomy

Interventions

Laparoscopic cholecystectomy PROCEDURE

Laparoscopic cholecystectomy will be performed using the standard American 4-port technique, insufflation will be achieved using CO2 to 15mmHg of pressure. Calot's triangle will be dissected until the critical view of safety is reached, being careful to dissect above the R4U line. After reaching the critical view of safety, two proximal and one distal clip will be placed on both the cystic conduct and artery separately, cutting the clips and then dissecting the gallbladder in a cystfundic direction. When the critical view of safety is not reached, the surgeon may perform a fundus-first cholecystectomy, subtotal cholecystectomy, conversion to open procedure, intraoperative cholangiography or cholecystostomy to their own discretion. It will also be the surgeon's criteria to employ or not a drain system in the surgical site. The decision for theses interventions will be taken intraoperatively and will be according to findings during the procedure.

Early cholecystectomy; Interval cholecystectomy

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years, diagnosis of pancreatitis according to Atlanta guidelines, moderately severe or severe pancreatitis (APACHE score ≥8 on admittance)
• Biliary pancreatitis diagnosed on imaging (be it ultrasound, magnetic resonance imaging and/or tomography)
• Recovery of pancreatitis by tolerance of oral intake (defined as 24 hours of food consumption of any consistency without emetic episodes and pain defined as 4/10 on the visual analogue score of pain) and written informed consent.

You may not qualify if:

• Pregnancy
• History of cholecystectomy
• Planned open cholecystectomy
• Pancreatitis-associated complication before laparoscopic cholecystectomy (compartment syndrome, bleeding and/or need for peripancreatic collection drainage)
• Chronic pancreatitis,
• More than one episode of pancreatitis
• Active malignant disease
• Septic shock
• Choledocholithiasis not resolved by ERCP, post-ERCP perforation and post-ERCP concomitant pancreatitis.

Sponsors & Collaborators

• Hospital Universitario Mayor Méderi: lead
• Universidad del Rosario: collaborator

Study Sites (2)

Hospital Universitario Mayor-Méderi

Bogota, Cundinamarca, 111221, Colombia

RECRUITING

Hospital Universitario Méderi Barrios Unidos

Bogota, Cundinamarca, 111221, Colombia

RECRUITING

Related Publications (17)

• Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.

  PMID: 23100216 BACKGROUND

• Yokoe M, Takada T, Mayumi T, Yoshida M, Isaji S, Wada K, Itoi T, Sata N, Gabata T, Igarashi H, Kataoka K, Hirota M, Kadoya M, Kitamura N, Kimura Y, Kiriyama S, Shirai K, Hattori T, Takeda K, Takeyama Y, Hirota M, Sekimoto M, Shikata S, Arata S, Hirata K. Japanese guidelines for the management of acute pancreatitis: Japanese Guidelines 2015. J Hepatobiliary Pancreat Sci. 2015 Jun;22(6):405-32. doi: 10.1002/jhbp.259. Epub 2015 May 13.

  PMID: 25973947 BACKGROUND

• Leppaniemi A, Tolonen M, Tarasconi A, Segovia-Lohse H, Gamberini E, Kirkpatrick AW, Ball CG, Parry N, Sartelli M, Wolbrink D, van Goor H, Baiocchi G, Ansaloni L, Biffl W, Coccolini F, Di Saverio S, Kluger Y, Moore E, Catena F. 2019 WSES guidelines for the management of severe acute pancreatitis. World J Emerg Surg. 2019 Jun 13;14:27. doi: 10.1186/s13017-019-0247-0. eCollection 2019.

  PMID: 31210778 BACKGROUND

• Prasanth J, Prasad M, Mahapatra SJ, Krishna A, Prakash O, Garg PK, Bansal VK. Early Versus Delayed Cholecystectomy for Acute Biliary Pancreatitis: A Systematic Review and Meta-Analysis. World J Surg. 2022 Jun;46(6):1359-1375. doi: 10.1007/s00268-022-06501-4. Epub 2022 Mar 19.

  PMID: 35306590 BACKGROUND

• Forsmark CE, Vege SS, Wilcox CM. Acute Pancreatitis. N Engl J Med. 2016 Nov 17;375(20):1972-1981. doi: 10.1056/NEJMra1505202. No abstract available.

  PMID: 27959604 BACKGROUND

• Nealon WH, Bawduniak J, Walser EM. Appropriate timing of cholecystectomy in patients who present with moderate to severe gallstone-associated acute pancreatitis with peripancreatic fluid collections. Ann Surg. 2004 Jun;239(6):741-9; discussion 749-51. doi: 10.1097/01.sla.0000128688.97556.94.

  PMID: 15166953 BACKGROUND

• Ackermann TG, Cashin PA, Alwan M, Wewelwala CC, Tan D, Vu AN, Bowers KA, Berry R, Croagh DG. The Role of Laparoscopic Cholecystectomy After Severe and/or Necrotic Pancreatitis in the Setting of Modern Minimally Invasive Management of Pancreatic Necrosis. Pancreas. 2020 Aug;49(7):935-940. doi: 10.1097/MPA.0000000000001601.

  PMID: 32658078 BACKGROUND

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

• Gupta V, Jain G. Safe laparoscopic cholecystectomy: Adoption of universal culture of safety in cholecystectomy. World J Gastrointest Surg. 2019 Feb 27;11(2):62-84. doi: 10.4240/wjgs.v11.i2.62.

  PMID: 30842813 BACKGROUND

• Working Group IAP/APA Acute Pancreatitis Guidelines. IAP/APA evidence-based guidelines for the management of acute pancreatitis. Pancreatology. 2013 Jul-Aug;13(4 Suppl 2):e1-15. doi: 10.1016/j.pan.2013.07.063.

  PMID: 24054878 BACKGROUND

• Tenner S, Baillie J, DeWitt J, Vege SS; American College of Gastroenterology. American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol. 2013 Sep;108(9):1400-15; 1416. doi: 10.1038/ajg.2013.218. Epub 2013 Jul 30.

  PMID: 23896955 BACKGROUND

• Li J, Chen J, Tang W. The consensus of integrative diagnosis and treatment of acute pancreatitis-2017. J Evid Based Med. 2019 Feb;12(1):76-88. doi: 10.1111/jebm.12342.

  PMID: 30806495 BACKGROUND

• Sun W, An LY, Bao XD, Qi YX, Yang T, Li R, Zheng SY, Sun DL. Consensus and controversy among severe pancreatitis surgery guidelines: a guideline evaluation based on the Appraisal of Guidelines for Research and Evaluation II (AGREE II) tool. Gland Surg. 2020 Oct;9(5):1551-1563. doi: 10.21037/gs-20-444.

  PMID: 33224831 BACKGROUND

• Hughes DL, Morris-Stiff G. Determining the optimal time interval for cholecystectomy in moderate to severe gallstone pancreatitis: A systematic review of published evidence. Int J Surg. 2020 Dec;84:171-179. doi: 10.1016/j.ijsu.2020.11.016. Epub 2020 Nov 20.

  PMID: 33227531 BACKGROUND

• da Costa DW, Bouwense SA, Schepers NJ, Besselink MG, van Santvoort HC, van Brunschot S, Bakker OJ, Bollen TL, Dejong CH, van Goor H, Boermeester MA, Bruno MJ, van Eijck CH, Timmer R, Weusten BL, Consten EC, Brink MA, Spanier BWM, Bilgen EJS, Nieuwenhuijs VB, Hofker HS, Rosman C, Voorburg AM, Bosscha K, van Duijvendijk P, Gerritsen JJ, Heisterkamp J, de Hingh IH, Witteman BJ, Kruyt PM, Scheepers JJ, Molenaar IQ, Schaapherder AF, Manusama ER, van der Waaij LA, van Unen J, Dijkgraaf MG, van Ramshorst B, Gooszen HG, Boerma D; Dutch Pancreatitis Study Group. Same-admission versus interval cholecystectomy for mild gallstone pancreatitis (PONCHO): a multicentre randomised controlled trial. Lancet. 2015 Sep 26;386(10000):1261-1268. doi: 10.1016/S0140-6736(15)00274-3.

  PMID: 26460661 BACKGROUND

• Sinha R. Early laparoscopic cholecystectomy in acute biliary pancreatitis: the optimal choice? HPB (Oxford). 2008;10(5):332-5. doi: 10.1080/13651820802247078.

  PMID: 18982148 BACKGROUND

• Ramirez-Giraldo C, Conde Monroy D, Daza Vergara JA, Isaza-Restrepo A, Van-Londono I, Trujillo-Guerrero L. Timing of CHolecystectomy In Severe PAncreatitis (CHISPA): study protocol for a randomized controlled trial. BMJ Surg Interv Health Technol. 2024 Mar 7;6(1):e000246. doi: 10.1136/bmjsit-2023-000246. eCollection 2024.

  PMID: 38463464 DERIVED

MeSH Terms

Conditions

Pancreatitis; Cholelithiasis

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Biliary Tract Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Camilo Ramirez-Giraldo, MD

  Hospital Universitario Mayor Méderi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Camilo Ramírez-Giraldo, MD

CONTACT

+5773206770474; ramirezgiraldocamilo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Surgeon

Model Details: CHISPA is a randomized controlled, parallel-group, superiority clinical trial. Patients will be randomly allocated to receive early laparoscopic cholecystectomy (within 72 hours after randomization) or interval laparoscopic cholecystectomy (30 +/- 5 days after randomization).

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 2, 2023
• Study Start: April 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: It is in our plans once we obtain a register number from Clinical Trials in order to publish the protocol, statistical analysis plan and clinical study report in a scientific journal so it will be available to all people interested.
• Access Criteria: It is in our plans to be published in a scientific journal available to all people interested.

Locations

CO (2)