Evidence Based Management of Acute Biliary Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Mortality rate of acute biliary pancreatitis in the study period
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all cases with acute biliary pancreatitis
排除标准
- •all cases with non biliary pancreatitis
研究组 & 干预措施
application of recent guidelines in the management of acute biliary pancreatitis
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
干预措施: serum lipase or amylase (Diagnostic Test)
application of recent guidelines in the management of acute biliary pancreatitis
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
干预措施: ultrasound (Device)
application of recent guidelines in the management of acute biliary pancreatitis
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
干预措施: CT (Device)
application of recent guidelines in the management of acute biliary pancreatitis
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
干预措施: Liver enzymes (Bilirubin, alanine transferase (ALT), aspartate aminotransferase, (AST) and alkaline phosphatase). Calcium. Triglycerides. (Diagnostic Test)
application of recent guidelines in the management of acute biliary pancreatitis
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
干预措施: EUS /Secretin-stimulated magnetic resonance cholangiopancreatography (MRCP) (Device)
application of recent guidelines in the management of acute biliary pancreatitis
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
干预措施: Ringer lactate (Drug)
application of recent guidelines in the management of acute biliary pancreatitis
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
干预措施: NSAID / paracetamol +/- opiates+/- epidural analgesia (Combination Product)
application of recent guidelines in the management of acute biliary pancreatitis
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
干预措施: Quinolones + Metronidazole /Carbapenems ± Metronidazole (Combination Product)
application of recent guidelines in the management of acute biliary pancreatitis
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
干预措施: Fresubin 2Kcal fiber drink (Dietary Supplement)
application of recent guidelines in the management of acute biliary pancreatitis
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
干预措施: nasogastric tube (Device)
application of recent guidelines in the management of acute biliary pancreatitis
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
干预措施: retroperitoneal necrosectomy (Procedure)
application of recent guidelines in the management of acute biliary pancreatitis
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
干预措施: open necrosectomy (Procedure)
application of recent guidelines in the management of acute biliary pancreatitis
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
干预措施: Endoscopic transmural cystogastrostomy (Procedure)
application of recent guidelines in the management of acute biliary pancreatitis
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
干预措施: open cystogastrostomy (Procedure)
application of recent guidelines in the management of acute biliary pancreatitis
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
干预措施: percutaneous catheter drainage (PCD) for infected necrosis (Procedure)
application of recent guidelines in the management of acute biliary pancreatitis
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
干预措施: Endoscopic ultrasound (EUS) guided aspiration for infected necrosis (Procedure)
结局指标
主要结局
Mortality rate of acute biliary pancreatitis in the study period
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: up to 6 months following intervention
Data were tabulated and statistically analyzed in terms of percentages
次要结局
- age of cases with acute biliary pancreatitis in Sharqia in years(at admission)
- Sex of cases with acute biliary pancreatitis in Sharqia (Males and females)(at admission)
研究者
yasmine Hany Hegab
principal investigator
Zagazig University