Election of the Optimal Moment of Colecistectomy After Mild Biliary Pancreatitis

Pancreatitis, Acute Clinical Trial

Official title:

Multicenter Prospective Randomized Study to Choose the Optimal Moment of Colecistectomy After Mild Biliary Pancreatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04625712
• Other study ID #: 16/41
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: November 2020
• Source: Consorci Sanitari Integral
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years.

• Diagnosis of acute mild biliary pancreatitis according to Altanta 2012 criteria.

• Signed informed consent. Exclusion Criteria

• ASA IV.

• Alcohol abuse or chronic pancreatitis.

• Not having assessed the presence of residual choledocolithiasis (cholangioNMR / intraoperative cholangiography)

• Pregnancy.

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Pancreatitis
• Pancreatitis, Acute

Intervention

Procedure:
• Cholecystectomy
Cholecystectomy within the first week after a mild acute biliary pancreatitis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Consorci Sanitari Integral

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients presenting morbidity associated with cholescystectomy	Number of patients with surgical complications	30 days after surgical intervention