Evidence Based Management of Acute Biliary Pancreatitis

Completed

• Conditions: Acute Pancreatitis
• Interventions: Diagnostic Test: serum lipase or amylase; Device: ultrasound; Device: CT; Diagnostic Test: Liver enzymes (Bilirubin, alanine transferase (ALT), aspartate aminotransferase, (AST) and alkaline phosphatase). Calcium. Triglycerides.; Device: EUS /Secretin-stimulated magnetic resonance cholangiopancreatography (MRCP); Drug: Ringer lactate; Combination Product: NSAID / paracetamol +/- opiates+/- epidural analgesia; Combination Product: Quinolones + Metronidazole /Carbapenems ± Metronidazole; Dietary Supplement: Fresubin 2Kcal fiber drink; Device: nasogastric tube; Procedure: retroperitoneal necrosectomy; Procedure: open necrosectomy; Procedure: Endoscopic transmural cystogastrostomy; Procedure: open cystogastrostomy; Procedure: percutaneous catheter drainage (PCD) for infected necrosis; Procedure: Endoscopic ultrasound (EUS) guided aspiration for infected necrosis

• Registration Number: NCT04615702
• Lead Sponsor: Zagazig University

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 Timeline

• Study Start: 2017-05-15
• Primary Completion: 2019-05-15
• Study Completion: 2019-05-15
• Study First Submitted: 2020-10-21
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-03
• Last Update Submitted: 2020-11-03
• Study First Posted: 2020-11-04
• Last Update Posted: 2020-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• all cases with acute biliary pancreatitis

Exclusion Criteria

• all cases with non biliary pancreatitis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
application of recent guidelines in the management of acute biliary pancreatitis	serum lipase or amylase	all patients subjected to the following: Confirmation of the diagnosis of acute pancreatitis, Diagnosis of the cause either biliary or not, Severity scoring and Evidence based management regarding Initial management, Intervention as indicated, Prevention of recurrence and Follow up
application of recent guidelines in the management of acute biliary pancreatitis	ultrasound	all patients subjected to the following: Confirmation of the diagnosis of acute pancreatitis, Diagnosis of the cause either biliary or not, Severity scoring and Evidence based management regarding Initial management, Intervention as indicated, Prevention of recurrence and Follow up
application of recent guidelines in the management of acute biliary pancreatitis	CT	all patients subjected to the following: Confirmation of the diagnosis of acute pancreatitis, Diagnosis of the cause either biliary or not, Severity scoring and Evidence based management regarding Initial management, Intervention as indicated, Prevention of recurrence and Follow up
application of recent guidelines in the management of acute biliary pancreatitis	Liver enzymes (Bilirubin, alanine transferase (ALT), aspartate aminotransferase, (AST) and alkaline phosphatase). Calcium. Triglycerides.	all patients subjected to the following: Confirmation of the diagnosis of acute pancreatitis, Diagnosis of the cause either biliary or not, Severity scoring and Evidence based management regarding Initial management, Intervention as indicated, Prevention of recurrence and Follow up
application of recent guidelines in the management of acute biliary pancreatitis	EUS /Secretin-stimulated magnetic resonance cholangiopancreatography (MRCP)	all patients subjected to the following: Confirmation of the diagnosis of acute pancreatitis, Diagnosis of the cause either biliary or not, Severity scoring and Evidence based management regarding Initial management, Intervention as indicated, Prevention of recurrence and Follow up
application of recent guidelines in the management of acute biliary pancreatitis	Ringer lactate	all patients subjected to the following: Confirmation of the diagnosis of acute pancreatitis, Diagnosis of the cause either biliary or not, Severity scoring and Evidence based management regarding Initial management, Intervention as indicated, Prevention of recurrence and Follow up
application of recent guidelines in the management of acute biliary pancreatitis	NSAID / paracetamol +/- opiates+/- epidural analgesia	all patients subjected to the following: Confirmation of the diagnosis of acute pancreatitis, Diagnosis of the cause either biliary or not, Severity scoring and Evidence based management regarding Initial management, Intervention as indicated, Prevention of recurrence and Follow up
application of recent guidelines in the management of acute biliary pancreatitis	Quinolones + Metronidazole /Carbapenems ± Metronidazole	all patients subjected to the following: Confirmation of the diagnosis of acute pancreatitis, Diagnosis of the cause either biliary or not, Severity scoring and Evidence based management regarding Initial management, Intervention as indicated, Prevention of recurrence and Follow up
application of recent guidelines in the management of acute biliary pancreatitis	Fresubin 2Kcal fiber drink	all patients subjected to the following: Confirmation of the diagnosis of acute pancreatitis, Diagnosis of the cause either biliary or not, Severity scoring and Evidence based management regarding Initial management, Intervention as indicated, Prevention of recurrence and Follow up
application of recent guidelines in the management of acute biliary pancreatitis	nasogastric tube	all patients subjected to the following: Confirmation of the diagnosis of acute pancreatitis, Diagnosis of the cause either biliary or not, Severity scoring and Evidence based management regarding Initial management, Intervention as indicated, Prevention of recurrence and Follow up
application of recent guidelines in the management of acute biliary pancreatitis	retroperitoneal necrosectomy	all patients subjected to the following: Confirmation of the diagnosis of acute pancreatitis, Diagnosis of the cause either biliary or not, Severity scoring and Evidence based management regarding Initial management, Intervention as indicated, Prevention of recurrence and Follow up
application of recent guidelines in the management of acute biliary pancreatitis	open necrosectomy	all patients subjected to the following: Confirmation of the diagnosis of acute pancreatitis, Diagnosis of the cause either biliary or not, Severity scoring and Evidence based management regarding Initial management, Intervention as indicated, Prevention of recurrence and Follow up
application of recent guidelines in the management of acute biliary pancreatitis	Endoscopic transmural cystogastrostomy	all patients subjected to the following: Confirmation of the diagnosis of acute pancreatitis, Diagnosis of the cause either biliary or not, Severity scoring and Evidence based management regarding Initial management, Intervention as indicated, Prevention of recurrence and Follow up
application of recent guidelines in the management of acute biliary pancreatitis	open cystogastrostomy	all patients subjected to the following: Confirmation of the diagnosis of acute pancreatitis, Diagnosis of the cause either biliary or not, Severity scoring and Evidence based management regarding Initial management, Intervention as indicated, Prevention of recurrence and Follow up
application of recent guidelines in the management of acute biliary pancreatitis	percutaneous catheter drainage (PCD) for infected necrosis	all patients subjected to the following: Confirmation of the diagnosis of acute pancreatitis, Diagnosis of the cause either biliary or not, Severity scoring and Evidence based management regarding Initial management, Intervention as indicated, Prevention of recurrence and Follow up
application of recent guidelines in the management of acute biliary pancreatitis	Endoscopic ultrasound (EUS) guided aspiration for infected necrosis	all patients subjected to the following: Confirmation of the diagnosis of acute pancreatitis, Diagnosis of the cause either biliary or not, Severity scoring and Evidence based management regarding Initial management, Intervention as indicated, Prevention of recurrence and Follow up

Primary Outcome Measures

Name	Time	Method
Mortality rate of acute biliary pancreatitis in the study period	from admission to 6 months following admission	Data were tabulated and statistically analyzed in terms of percentages
length of hospital stay of mild and severe cases with acute biliary pancreatitis	up to 6 months	Data were tabulated and statistically analyzed in terms of frequencies length of hospital stay in days
success rate of minimally invasive techniques (percutaneaous catheter drainage, endoscopic approach and retroperitoneal approach) in cases with infected walled off necrosis	immediately following intervention to 6 weeks following intervention	Data were tabulated and statistically analyzed in terms of percentages Success of the intervention means patient condition improves \[clinical (vital signs) , laboratory (CBC, kidney and liver function tests) and radiological improvement (no residual collection in CT)\] and that there is no need for further intervention to control the disease till patient discharge
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	up to 6 months following intervention	Data were tabulated and statistically analyzed in terms of percentages

Secondary Outcome Measures

Name	Time	Method
age of cases with acute biliary pancreatitis in Sharqia in years	at admission	Data were tabulated and statistically analyzed in terms of mean
Sex of cases with acute biliary pancreatitis in Sharqia (Males and females)	at admission	Data were tabulated and statistically analyzed in terms of percentages

Trial Locations

Locations (1)

Zagazig University Faculty of Human Medicine; 🇪🇬 Zagazig, Egypt