ANGH Prospective Cohort of Mild and Severe Acute Biliary Pancreatitis

Terminated

• Conditions: Acute Biliary Pancreatitis
• Interventions: Procedure: Cholecystectomy

• Registration Number: NCT05549349
• Lead Sponsor: Julia TRAVAGLI

Brief Summary

The main objective of this work is to evaluate the recurrence of biliary episodes before cholecystectomy (hepatic colic, lithiasic migration, cholangitis, cholecystitis, pancreatitis, necrosis infections) in patients with acute biliary pancreatitis of any severity depending on the type of nutrition (oral, enteral or parenteral).

Detailed Description

Acute pancreatitis (AP) is one of the frequent causes of hospitalization in gastroenterology with an annual incidence of 13-45 cases per 100,000 patients. If we refer to the data in the white paper, hospitalizations for abdominal emergencies, such as PA, take place in at least 60% of cases in General Hospital Centers (CHG). Among these AP, approximately 40% of AP are secondary to a biliary lithiasis pathology. The main modalities of the initial management of AP have been the subject of several national and international recommendations and consensuses. Although it is well accepted that early refeeding during the first 48 hours reduces the appearance of a systemic inflammatory response syndrome (SIRS) or a collection infection, the feeding methods in the event of pancreatitis Acute biliary (ABP) during the acute phase using the oral route if it is tolerated or the enteral route by nasogastric tube before cholecystectomy remains debated.

Thus, in case of delayed cholecystectomy after AP, there is no consensus on the feeding methods after the acute phase (oral or enteral) until cholecystectomy nor on the benefit of a prophylactic endoscopic sphincterotomy in the absence of cholangitis.

Study Timeline

• Study First Submitted: 2022-09-19
• Study First Submitted QC: 2022-09-19
• Study First Posted: 2022-09-22
• Study Start: 2022-10-10
• Primary Completion: 2022-10-10
• Study Completion: 2024-07-10
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Adult over 18 years old
• Affiliated to a social security scheme.
• Patients with acute biliary pancreatitis

Exclusion Criteria

• Patients with chronic pancreatitis
• Patients with a previous cholecystectomy
• Patients under guardianship, curatorship or legal protection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cholecystectomy during hospitalization	Cholecystectomy	In this group, patients will have their cholecystectomy during the initial hospitalization. We will look at the mode of feeding between the biliary crisis and the cholecystectomy.
Delayed cholecystectomy	Cholecystectomy	In this group, patients will have their cholecystectomy deferred from their initial hospitalization for various reasons. They will be seen again 3 months after leaving hospital. They will or will not have been cholecystectomized during this interval. Their mode of feeding as well as biliary events will be studied.

Primary Outcome Measures

Name	Time	Method
biliary events	3 month	Assess the recurrence of biliary events before cholecystectomy

Trial Locations

Locations (1)

MORRYOUSSEF Frederick; 🇫🇷 Poissy, France