Clinical trial NCT04615702: Evidence Based Management of Acute Biliary Pancreatitis
Official title: Evidence Based Management of Acute Biliary Pancreatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Pancreatitis
Keywords: acute pancreatitis guidelines
acute biliary pancreatitis
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-11-04
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All cases with acute biliary pancreatitis admitted to surgery department in the study period were included in the study

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.

Eligibility criteria: Inclusion Criteria:

* all cases with acute biliary pancreatitis

Exclusion Criteria:

* all cases with non biliary pancreatitis

Primary outcomes:
measure: success rate of minimally invasive techniques (percutaneaous catheter drainage, endoscopic approach and retroperitoneal approach) in cases with infected walled off necrosis
timeFrame: immediately following intervention to 6 weeks following intervention
measure: rate of complications of minimally invasive techniques used in the management of cases with infected walled off necrosis including bleeding, fistula, wound infection, incisional hernia
timeFrame: up to 6 months following intervention
measure: Mortality rate of acute biliary pancreatitis in the study period
timeFrame: from admission to 6 months following admission
measure: length of hospital stay of mild and severe cases with acute biliary pancreatitis
timeFrame: up to 6 months
Secondary outcomes:
measure: age of cases with acute biliary pancreatitis in Sharqia in years
timeFrame: at admission
measure: Sex of cases with acute biliary pancreatitis in Sharqia (Males and females)
timeFrame: at admission
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University Faculty of Human Medicine
Study officials:
affiliation: zagazig university faculty of human medicine
name: yasmine Hegab
role: PRINCIPAL_INVESTIGATOR
References:
citation: Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.
citation: Isaji S, Takada T, Mayumi T, Yoshida M, Wada K, Yokoe M, Itoi T, Gabata T. Revised Japanese guidelines for the management of acute pancreatitis 2015: revised concepts and updated points. J Hepatobiliary Pancreat Sci. 2015 Jun;22(6):433-45. doi: 10.1002/jhbp.260.
citation: Tenner S, Baillie J, DeWitt J, Vege SS; American College of Gastroenterology. American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol. 2013 Sep;108(9):1400-15; 1416. doi: 10.1038/ajg.2013.218. Epub 2013 Jul 30.
citation: Working Group IAP/APA Acute Pancreatitis Guidelines. IAP/APA evidence-based guidelines for the management of acute pancreatitis. Pancreatology. 2013 Jul-Aug;13(4 Suppl 2):e1-15. doi: 10.1016/j.pan.2013.07.063.