Election of the Optimal Moment of Colecistectomy After Mild Biliary Pancreatitis

NCT ID: NCT04625712

Last Updated: 2020-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2019-12-31

Brief Summary

Introduction Acute pancreatitis is the third gastrointestinal cause of hospital admission. It is estimated that 35-60% have a biliary origin, and most of them are mild.

After a mild acute biliary pancreatitis (ABP), there is a high risk of recurrence of others biliary events. 15-20% of patients will suffer another pancreatitis, cholangitis, choledocolithiasis, or cholecystitis. Therefore, is necessary a definitive treatment.

Although it is suggested to perform cholecystectomy early, there is still insufficient scientific evidence on this subject. All publications have biases and do not allow establish recommendations. In addition, the usual clinical practice tends to postpone the cholecystectomy, because of doubts about the safety of early intervention and for hospital logistical reasons. On the other hand, is discussing if early cholecystectomy carried out more persistence of residual cholelithiasis, explains for the pathophysiology of the ABP.

Finally, it is important to mention, that in our environment 25% of the patients with an ABP are more than 75 years old. There are not any trial that includes this age group.

Objectives Demonstrate that early cholecystectomy is feasible in all patients, including elderly patients, and decreases the number of readmissions for other biliary events.

Material and Methods It is being done a multicenter prospective randomized trial. After an ABP, patients are randomized in two treatment branches. Group A is cholecystectomy within the first week after the ABP. Group B four weeks later.

There are collect data from demographic information, comorbidities, biliary events before the surgery, residual choledocolithiasis, difficulty of the surgical technique, postoperative complications and patients are follow-up for 6 months.

To obtain a representative sample of the population, we consider it appropriate to include all age groups, including patients older than 75 years.

Expected results With this study we pretend to demonstrate that early cholecystectomy is feasible and safe. It does not increase the number of residual choledocolithiasis, and prevents readmissions for new biliary events.

Conditions

Pancreatitis, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A (experimental arm, surgery intervention)

Cholecystectomy within the first week after a mild acute biliary pancreatitis.

Group Type: EXPERIMENTAL

Cholecystectomy

Intervention Type: PROCEDURE

Cholecystectomy within the first week after a mild acute biliary pancreatitis

Group B (active comparator, surgery intervention)

Cholecystectomy four weeks later a mild acute biliary pancreatitis.

Group Type: ACTIVE_COMPARATOR

Cholecystectomy

Intervention Type: PROCEDURE

Cholecystectomy within the first week after a mild acute biliary pancreatitis

Interventions

Cholecystectomy

Cholecystectomy within the first week after a mild acute biliary pancreatitis

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years.
• Diagnosis of acute mild biliary pancreatitis according to Altanta 2012 criteria.

Exclusion Criteria

• ASA IV.
• Alcohol abuse or chronic pancreatitis.
• Not having assessed the presence of residual choledocolithiasis (cholangioNMR / intraoperative cholangiography)
• Pregnancy.

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• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Consorci Sanitari Integral

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

16/41

Identifier Type: -

Identifier Source: org_study_id