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

J

Julia TRAVAGLI

Status

Terminated

Conditions

Acute Biliary Pancreatitis

Treatments

Procedure: Cholecystectomy

Study type

Observational

Funder types

Other

Identifiers

NCT05549349
2022-A00303-40

Details and patient eligibility

About

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).

Full 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.

Enrollment

2,000 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

2,000 participants in 2 patient groups

Cholecystectomy during hospitalization
Description:
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.
Treatment:
Procedure: Cholecystectomy
Delayed cholecystectomy
Description:
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.
Treatment:
Procedure: Cholecystectomy

Trial contacts and locations

1

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Central trial contact

Julia Travagli, phD

Data sourced from clinicaltrials.gov

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