Viewing Study NCT04615702


Ignite Creation Date: 2025-12-25 @ 3:52 AM
Ignite Modification Date: 2025-12-26 @ 2:41 AM
Study NCT ID: NCT04615702
Status: COMPLETED
Last Update Posted: 2020-11-05
First Post: 2020-10-21
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Evidence Based Management of Acute Biliary Pancreatitis
Sponsor: Zagazig University
Organization:

Study Overview

Official Title: Evidence Based Management of Acute Biliary Pancreatitis
Status: COMPLETED
Status Verified Date: 2020-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study aims to assess the outcome of standardized evidence-based care to all patients with acute biliary pancreatitis treated at surgery department, Zagazig University hospitals during the period from may, 2017 to may 2019.
Detailed Description: Acute pancreatitis (AP) is one of the most important gastrointestinal disorders causing emotional and physical human burden . The annual incidence worldwide for AP is 4.9-73.4 cases per 100,000 people and the overall mortality rate is 4 to 8%, which increases to 33% in patients with infected necrosis. AP is diagnosed when two of three criteria are fulfilled: typical abdominal pain of AP, more than three times elevated serum amylase/lipase level and signs of AP on imaging.

It is necessary to clarify the etiology of AP promptly. The diagnosis of gallstones, as the leading cause for AP, should have the top priority as that will direct the treatment policy. Long standing alcohol consumption and gallstones disease incriminated in the majority of cases with AP. Small common bile duct stones, in particular, are the cause of AP in approximately 32 to 40% of cases. In 10-30% of cases, the cause is unknown, so studies have suggested that up to 70% of cases of idiopathic pancreatitis are secondary to biliary microlithiasis.

The pathogenesis of biliary AP has been intensively investigated. Many theories explain how gallstones can trigger AP. The predominant theories include common pathway theory and gallstone migration theory. In general, AP occurs when intracellular protective mechanisms fail to prevent trypsinogen activation or reduce trypsin activity.

It is important that management of such potentially life threatening condition to be guided by an evidence-based approach. After comparing the Japanese (JPN) Guidelines 2015 and its former edition 2010 with the other two guidelines, International Association of Pancreatology/American Pancreas Association guidelines (IAP/APA), 2013 and American College of Gastroenterology (ACG), 2013, the JPN Guidelines, 2015 proved to be the highest quality regarding its systematic literature review prepared by the meta-analysis team, including the grading of recommendations and providing pancreatitis bundles.

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: