CHISPA: Timing of CHolecystectomy In Severe PAncreatitis: Randomized Controlled Trial

Sponsor

Hospital Universitario Mayor Méderi (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06113419

Collaborator

Universidad del Rosario (Other)

134

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Pancreatitis Cholelithiasis	Procedure: Laparoscopic cholecystectomy	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

134 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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).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).

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Mar 1, 2026

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Early cholecystectomy Early laparoscopic cholecystectomy (within 72 hours 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.
Active Comparator: Interval 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.

Arm

Intervention/Treatment

Experimental: Early cholecystectomy

Early laparoscopic cholecystectomy (within 72 hours 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.

Active Comparator: Interval cholecystectomy

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

Procedure: Laparoscopic cholecystectomy

Outcome Measures

Primary Outcome Measures

Major complications [90 days]
Clavien-Dindo score III-V in patients with moderately severe and severe acute pancreatitis of biliary origin taken to early vs interval cholecystectomy

Secondary Outcome Measures

Recurrence [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
Mortality [90 days]
Determine differences in mortality between patients with moderately severe and severe acute pancreatitis of biliary origin taken to early vs interval cholecystectomy
Postoperative hospital stay length (general) [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
Minor complications [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
Postoperative hospital admittance and stay length in the ICU [90 days]
Compare differences in postoperative hospital admittance and stay length in the ICU in patients with moderately severe and severe acute pancreatitis of biliary origin taken to early vs interval cholecystectomy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.