Clinical trial NCT05549349: ANGH Prospective Cohort of Mild and Severe Acute Biliary Pancreatitis
Official title: ANGH Prospective Cohort of Mild and Severe Acute Biliary Pancreatitis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acute Biliary Pancreatitis
Lead sponsor: Poissy-Saint Germain Hospital
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: biliary events
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Poissy
country: France
facility: MORRYOUSSEF Frederick
Study officials:
affiliation: Poissy
name: Frederick MORRYOUSSEF, MD
role: PRINCIPAL_INVESTIGATOR
References: