ANGH Prospective Cohort of Mild and Severe Acute Biliary Pancreatitis

Acute Biliary Pancreatitis Clinical Trial

— CAPABLES  

Official title:

ANGH Prospective Cohort of Mild and Severe Acute Biliary Pancreatitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05549349
• Other study ID #: 2022-A00303-40
• Status: Not yet recruiting
• Start date: October 10, 2022
• Est. completion date: March 10, 2023

Study information

• Verified date: September 2022
• Source: Poissy-Saint Germain Hospital
• Contact: Julia Travagli, phD
• Phone: +33 1 39 27 40 47
• Email: julia.gross[@]ght-yvelinesnord.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: March 10, 2023
• Est. primary completion date: March 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Biliary Pancreatitis
• Pancreatitis

Intervention

Procedure:
• Cholecystectomy
Gallbladder removal

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Poissy-Saint Germain Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	biliary events	Assess the recurrence of biliary events before cholecystectomy	3 month