Early Cholecystectomy in Patients With Mild Gallstone Acute Pancreatitis

Not Applicable

Terminated

• Conditions: Gallstone Pancreatitis
• Interventions: Procedure: Early cholecystectomy; Procedure: Control (Delayed cholecystectomy)

• Registration Number: NCT02590978
• Lead Sponsor: Hospital del Salvador

Brief Summary

Randomized controlled trial to demonstrate the safety of early cholecystectomy (\<72h) in patients with mild gallstone pancreatitis. The purpose of this study is to demonstrate that there is a shorter hospital stay and no higher complication rates.

Detailed Description

Acute pancreatitis is a prevalent disease, responsible for 220.000 hospital admissions per year in the United States of America. In Chile, during year 2012 there were 76.463 hospital admissions for this diagnosis, with a mean hospital stay of 11,8 days and 25 deaths per year associated with this disease (250 deaths from 2002 to 2012). The most frequent etiology of pancreatitis in Chile is gallstones, which can be present in 80% of the patients admitted for acute pancreatitis. This can be explained by the high prevalence of gallstones among these patients.

Since Acosta and Ledesma demonstrated the association between gallstones and acute pancreatitis in 1974, cholecystectomy has been the most efficient treatment option to prevent recurrence that can reach even 30-40% in the first two weeks after the first episode. There is consensus in delaying the time of the cholecystectomy in patients with acute gallstone pancreatitis where mortality can be as high as 80% in patients presenting with severe cases. However, the vast majority of the patients will present with a mild pancreatitis requiring no more than basic medical support. In these patients, the role of surgery during the same hospital admission has been clearly demonstrated.

There is no current consensus with respect to the safety of performing cholecystectomy in patients with mild pancreatitis within 48 to 72 hours after the hospital admission. There are few well-designed observational studies and only one randomized clinical trial, which has demonstrated a significant decrease in hospital stay (7 to 4 days), without increasing the rate of complications or mortality. According to some models of analysis and decision, this strategy could reduce costs associated with prolonged hospital stays and improve the quality of life of these patients without jeopardizing patient safety.

Study Timeline

• Study First Submitted: 2015-10-27
• Study First Submitted QC: 2015-10-28
• Study First Posted: 2015-10-29
• Status Verified: 2015-12
• Study Start: 2015-12-01
• Primary Completion: 2017-11-01
• Study Completion: 2017-11-01
• Last Update Submitted: 2018-09-13
• Last Update Posted: 2018-09-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early cholecystectomy	Early cholecystectomy	Cholecystectomy within the first 72 hours of admission.
Control (Delayed cholecystectomy)	Control (Delayed cholecystectomy)	Standard care arm. Cholecystectomy is delayed until normalization of laboratory values, abdominal pain resolves and oral intake is restored.

Primary Outcome Measures

Name	Time	Method
Length of Stay (LOS)	90 dias	days

Secondary Outcome Measures

Name	Time	Method
Re-admission	90 days	yes/no
Biliary complications	90 days	biloma, bile leak, residual choledocholithiasis
Operative time	surgery	operative time in minutes
medical complications	30 days	any medical complication using Clavien-dindo classification
Wound infection	30 days	yes/no
Endoscopic retrograde cholangio-pancreatography (ERCP)	90 days	yes/no
Conversion	surgery	yes/no

Trial Locations

Locations (1)

Boris Marinkovic; 🇨🇱 Santiago, Región Metropolitana, Chile