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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05549349
Other study ID # 2022-A00303-40
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT03085407 - Acute Biliary Pancreatitis - Optimal Time for Cholecystectomy N/A
Recruiting NCT02668081 - Comparing the Effects of EST and EPBD in Patients With Acute Biliary Pancreatitis N/A
Completed NCT02430285 - Early EUS in Acute Biliary Pancreatitis N/A