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NCT Number: NCT06113419

Timing of CHolecystectomy In Severe PAncreatitis

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.

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Key information

Conditions

Acute Pancreatitis Biliary Tract Diseases Cholelithiasis Digestive System Diseases Pancreatic Diseases Pancreatitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Mayor-Méderi, Bogota, Cundinamarca, Colombia

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About this study

CHISPA is a randomized controlled, parallel-group, superiority clinical trial. An intention- to-treat analysis will be performed. It seeks to evaluate differences between patients taken to early cholecystectomy during hospital admission (72 hours after randomization) versus delayed cholecystectomy (30 +/- 5 days after randomization). Primary endpoint is major complications associated to laparoscopic cholecystectomy defined as a Clavien-Dindo score of over III/V during the first 90 days after the procedure. Secondary endpoints include recurrence of biliary disease, mortality, minor complications (Clavien-Dindo score below III/V), days of postoperative hospital stay, and days admitted in an intensive care unit postoperatively.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Major complications (rates)

    Time frame: 90 days

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

  2. Major complications (rates)

    Time frame: 90 days

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

  3. Major complications (rates)

    Time frame: 90 days

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

Secondary outcomes

  1. Recurrence (rates)

    Time frame: 90 days

    Biliary disease recurrence defined as a new admission for recurrent pancreatitis, cholecystitis, cholangitis, choledocholithiasis, need fro ERCP or biliary colic previous to the surgical procedure until 90 postoperative days after it

  2. Mortality (rates)

    Time frame: 90 days

    Determine differences in mortality between patients with moderately severe and severe acute pancreatitis of biliary origin taken to early vs interval cholecystectomy

  3. Postoperative hospital stay length (days; median)

    Time frame: 90 days

    Compare differences in postoperative hospital stay length (general) in patients with moderately severe and severe acute pancreatitis of biliary origin taken to early vs interval cholecystectomy

  4. Minor complications (rates)

    Time frame: 90 days

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

  5. Postoperative stay length in the ICU (days; median)

    Time frame: 90 days

    Compare differences in postoperative stay length in the ICU in patients with moderately severe and severe acute pancreatitis of biliary origin taken to early vs interval cholecystectomy

Study contacts

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

Camilo Ramírez-Giraldo, MD

CONTACT

[email protected]

+5773206770474

Sponsors and collaborators

Lead sponsor

Hospital Universitario Mayor Méderi

Other

Collaborators

  • Universidad del Rosario

Registry information

Official study title

Timing of CHolecystectomy In Severe PAncreatitis (CHISPA): Study Protocol for a Randomized Controlled Trial.

Acronym: CHISPA

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 2, 2023
Registry last updated
Sep 15, 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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