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Timing of CHolecystectomy In Severe PAncreatitis

ConditionsAcute PancreatitisCholelithiasis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Universitario Mayor Méderi

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Pregnancy

History of cholecystectomy

Planned open cholecystectomy

Pancreatitis-associated complication before laparoscopic cholecystectomy (compartment syndrome, bleeding and/or need for peripancreatic collection drainage)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Laparoscopic cholecystectomy

    Procedure/Surgery

    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.

Treatment groups

134 Participants
are divided into 2 treatment groups
Group A: Early cholecystectomyExperimental treatment 1 intervention
Group B: Interval cholecystectomyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Locations

2

Map coordinates are unavailable for these locations. Locations are shown below instead.

Hospital Universitario Mayor-MéderiRecruiting111221, Bogota, CundinamarcaColombiaColombia
Hospital Universitario Méderi Barrios UnidosRecruiting111221, Bogota, CundinamarcaColombiaColombia

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Universitario Mayor Méderi

Lead sponsor

Universidad del Rosario

Collaborator

Source ClinicalTrials.gov
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