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Trial of Index Cholecystectomy Versus Scheduled Cholecystectomy in Biliary Pancreatitis

NCT02630433 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2017-11-14

No results posted yet for this study

Summary

There are controversies optimal timing for cholecystectomy in patients with mild biliary pancreatitis. The safety of cholecystectomy performed during an episode of pancreatitis has been questioned. The aim of the present randomized controlled trial is to compare the outcome in terms of recurrent pancreatitis and gallstone-related events between index cholecystectomy, performed during the first admission for acute pancreatitis, and scheduled cholecystectomy, performed 4-6 weeks after discharge.

Conditions

Interventions

PROCEDURE

Index cholecystectomy

Cholecystectomy performed within 48 hours after inclusion, before discharge after admission for acute biliary pancreatitis.

PROCEDURE

Scheduled cholecystectomy

Cholecystectomy performed as a scheduled procedure 6 weeks after the first admission.

Sponsors & Collaborators

Principal Investigators

  • Gabriel Sandblom, Ass prof · Karolinska Institutet, CLINTEC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2017-11-12
Completion
2017-11-12

Countries

  • Sweden

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02630433 on ClinicalTrials.gov