ANGH Prospective Cohort of Mild and Severe Acute Biliary Pancreatitis

NCT ID: NCT05549349

Last Updated: 2025-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-10

Study Completion Date

2024-07-10

Brief Summary

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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

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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.

Conditions

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Acute Biliary Pancreatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Cholecystectomy

Intervention Type PROCEDURE

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.

Cholecystectomy

Intervention Type PROCEDURE

Gallbladder removal

Interventions

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Cholecystectomy

Gallbladder removal

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Julia TRAVAGLI

OTHER

Sponsor Role lead

Responsible Party

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Julia TRAVAGLI

PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Frederick MORRYOUSSEF, MD

Role: PRINCIPAL_INVESTIGATOR

Poissy

Locations

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MORRYOUSSEF Frederick

Poissy, , France

Site Status

Countries

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France

Other Identifiers

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2022-A00303-40

Identifier Type: -

Identifier Source: org_study_id

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