Clinical trial NCT06113419: Timing of CHolecystectomy in Severe PAncreatitis
Official title: Timing of CHolecystectomy in Severe PAncreatitis (CHISPA): Study Protocol for a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Pancreatitis
Cholelithiasis
Keywords: cholecystectomy
Acute Pancreatitis
Cholelithiasis
Lead sponsor: Hospital Universitario Mayor Méderi
Sponsor class: OTHER
Collaborators: name: Universidad del Rosario
First posted: 2023-11-02
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Major complications (rates)
timeFrame: 90 days
measure: Major complications (rates)
timeFrame: 90 days
measure: Major complications (rates)
timeFrame: 90 days
Secondary outcomes:
measure: Recurrence (rates)
timeFrame: 90 days
measure: Mortality (rates)
timeFrame: 90 days
measure: Postoperative hospital stay length (days; median)
timeFrame: 90 days
measure: Minor complications (rates)
timeFrame: 90 days
measure: Postoperative stay length in the ICU (days; median)
timeFrame: 90 days
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Hospital Universitario Mayor-Méderi
state: Cundinamarca
city: Bogota
country: Colombia
facility: Hospital Universitario Méderi Barrios Unidos
state: Cundinamarca
Study officials:
affiliation: Hospital Universitario Mayor Méderi
name: Camilo Ramirez-Giraldo, MD
role: PRINCIPAL_INVESTIGATOR
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