ANGH Prospective Cohort of Mild and Severe Acute Biliary Pancreatitis

NCT05549349 | Terminated

• 1 other identifier: 2022-A00303-40
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Biliary Pancreatitis

Outcome Measures

Primary Outcomes (1)

• biliary events

  Assess the recurrence of biliary events before cholecystectomy

  3 month

Study Arms (2)

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

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

Interventions

Cholecystectomy PROCEDURE

Gallbladder removal

Cholecystectomy during hospitalization; Delayed cholecystectomy

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Julia TRAVAGLI: lead

Study Sites (1)

MORRYOUSSEF Frederick

Poissy, 78300, France

Location

MeSH Terms

Interventions

Cholecystectomy

Intervention Hierarchy (Ancestors)

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

Study Officials

• Frederick MORRYOUSSEF, MD

  Poissy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 22, 2022
• Study Start: October 10, 2022
• Primary Completion: October 10, 2022
• Study Completion: July 10, 2024
• Last Updated: March 17, 2025

Record last verified: 2025-03

Locations

FR (1)