Election of the Optimal Moment of Colecistectomy After Mild Biliary Pancreatitis

NCT04625712 | Completed

• 1 other identifier: 16/41
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Number of patients presenting morbidity associated with cholescystectomy

  Number of patients with surgical complications

  30 days after surgical intervention

Study Arms (2)

Group A (experimental arm, surgery intervention)

EXPERIMENTAL

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

Procedure: Cholecystectomy

Group B (active comparator, surgery intervention)

ACTIVE COMPARATOR

Cholecystectomy four weeks later a mild acute biliary pancreatitis.

Procedure: Cholecystectomy

Interventions

Cholecystectomy PROCEDURE

Cholecystectomy within the first week after a mild acute biliary pancreatitis

Group A (experimental arm, surgery intervention); Group B (active comparator, surgery intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Consorci Sanitari Integral: lead

MeSH Terms

Conditions

Pancreatitis

Interventions

Cholecystectomy

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 12, 2020
• Study Start: January 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share