ANGH Prospective Cohort of Mild and Severe Acute Biliary Pancreatitis (CAPABLES)

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).

Study Overview

• Status: Terminated
• Conditions: Acute Biliary Pancreatitis
• Intervention / Treatment: Procedure: Cholecystectomy

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 Type: Observational
• Enrollment (Actual): 2000

Contacts and Locations

Study Locations

• France
  • Poissy, France, 78300
    • MORRYOUSSEF Frederick

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Recruitment of patients will be done in the gastroenterology departments of participating Hospitals. Information to patients will be provided by an investigator from the service.

Participation in this study will be offered to all patients fulfilling the inclusion and non-inclusion criteria. A specific written information note as well as clear and honest oral information will be given to patients meeting the inclusion criteria, before collecting their non-objection.

After collection of the patient's non-objection and allocation of a patient code, the investigator or his representative will complete an observation book (Case Report Form in English, CRF). This observation book will include clinical and paraclinical data from the patient's medical file.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cholecystectomy during hospitalization; 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.	Procedure: Cholecystectomy; Gallbladder removal
Delayed 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.	Procedure: Cholecystectomy; Gallbladder removal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
biliary events	Assess the recurrence of biliary events before cholecystectomy	3 month

Collaborators and Investigators

• Sponsor: Julia TRAVAGLI
• Investigators: Principal Investigator: Frederick MORRYOUSSEF, MD, Poissy

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2022
• Primary Completion (Actual): October 10, 2022
• Study Completion (Actual): July 10, 2024

Study Registration Dates

• First Submitted: September 19, 2022
• First Submitted That Met QC Criteria: September 19, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: 2022-A00303-40

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No