CTRI/2023/05/052196
Not yet recruiting
未知
The Early Surgery versus surgery as last resort for Chronic Pancreatitis-(ESSLaR) trial. - ESSLaR Trial
Department of surgical gastroenterology.0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: K860- Alcohol-induced chronic pancreatitis
- Sponsor
- Department of surgical gastroenterology.
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria
- •Age \> 18 years
- •typical clinical history of chronic pancreatitis
- •â?ª one or more of the following additional criteria for the diagnosis of CP:
- •1\. Pancreatic calcifications on CT or MRI imaging.
- •2\. Moderate or marked ductal lesions on endoscopic retrograde cholangiopancreatography (ERCP) or magnetic resonance cholangiopancreatography (MRCP) imaging.
- •3\. Marked and persistent exocrine insufficiency (defined as: a. pancreatic steatorrhea clearly relieved by enzyme supplementation, and/or b. fecal elastase levels of \<\= 200 micro gram/gram)
- •4\. Dilated pancreatic duct: dilated pancreatic duct of \>\= 5 mm, with or without enlargement of the pancreatic head.
- •5\. Presence of moderate, non\-debilitating pain FOR EARLY SURGERY GROUP
- •6 Presence of debilitating pain not amenable to strong opiods for standard surgery group
Exclusion Criteria
- •Exclusion criteria
- •1\.History of prolonged need of opioids\- weak opioids for CP for a total period of 6 months in the last 2 years.
- •2\.Previous pancreatic surgery
- •3\.Previous endoscopic dilatation or stenting of the pancreatic duct /biliary
- •4\.Autoimmune pancreatitis
- •5\.Stones and strictures exclusively located in the tail of the pancreas
- •6\.Fully impacted stones casting the entire main pancreatic duct (from head to tail) and possibly side branches
- •7\.Suspected or confirmed pancreatic malignancy
- •8\.Life expectancy of \< 1 year for any reason
- •9\.Presence of duodenal obstruction necessitating surgery.
Outcomes
Primary Outcomes
Not specified
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