An interventional study of Laparoscopic cholecystectomy in Acute Pancreatitis and Cholelithiasis, sponsored by Hospital Universitario Mayor Méderi. Recruiting at 2 sites in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Hospital Universitario Mayor Méderi · Not applicable, Interventional, and Treatment
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:
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.
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.
557 studies on the registry are indexed under Pancreatitis; 164 are open to participants now.
This study's planned enrollment of 134 is above the median of 100 across 349 interventional studies indexed under Pancreatitis.
Browse Pancreatitis studies →Hospital Universitario Mayor Méderi is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Early laparoscopic cholecystectomy (within 72 hours after randomization)
Procedure: Laparoscopic cholecystectomy
Interval laparoscopic cholecystectomy (30 +/- 5 days after randomization).
Procedure: Laparoscopic cholecystectomy
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.
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
Time frame: 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
Time frame: 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
Time frame: 90 days
Recurrence (rates)
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
Time frame: 90 days
Mortality (rates)
Determine differences in mortality between patients with moderately severe and severe acute pancreatitis of biliary origin taken to early vs interval cholecystectomy
Time frame: 90 days
Postoperative hospital stay length (days; median)
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
Time frame: 90 days
Minor complications (rates)
Clavien-Dindo score I-II in patients with moderately severe and severe acute pancreatitis of biliary origin taken to early vs interval cholecystectomy
Time frame: 90 days
Postoperative stay length in the ICU (days; median)
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
Time frame: 90 days
Plan to share: Yes — Data obtained and input into the database is anonymous, without any individual or identifying characteristics will be stored in a dataset from the Centro de Recursos para el Aprendizaje y la Investigación, property of and administered by the Universidad del Rosario as a plan of data management. Moreover, the different codes used in the analysis will be stored in this dataset.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Hospital Universitario Mayor Méderi