Is Pancreaticobiliary Reflux in Patients With Cholelithiasis and Without Cholelithiasis a Normal Phenomenon?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 197
- Locations
- 1
- Primary Endpoint
- Amylase and Lipase Values in Gallbladder Bile
Study Overview
Brief Summary
Pancreaticobiliary reflux has been found in patients with cholelithiasis and gallbladder cancer associated with normal pancreaticobiliary union. However, the presence of pancreaticobiliary reflux has not been studied in patients without gallstones (healthy gallbladders).
The authors believe that pancreaticobiliary reflux might be a normal phenomenon in patients with and without gallstones, although in patients with cholelithiasis it might constitute a pathological condition associated with dismotility of the biliary tree and the sphincter of Oddi.
Detailed Description
The objective of this study is to measure the levels of amylase and lipase in gallbladder bile of patients without gallstones and compare these values to the values of amylase and lipase of patients with gallstones and normal pancreaticobiliary union evidenced by intraoperative cholangiography.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age older than 15 years of age
- •Elective surgery
- •Normal intraoperative cholangiography
- •Normal preoperative serum amylase and lipase values
Exclusion Criteria
- •Common bile duct stones
- •Anatomic anomalies at the pancreaticobiliary junction evidenced by intraoperative cholangiography
- •Altered preoperative amylase and lipase levels
- •Altered preoperative hepatic function tests
- •Emergency surgery
Outcomes
Primary Outcomes
Amylase and Lipase Values in Gallbladder Bile
Time Frame: 24 hours
Normal values of lipase and amylase in gallbladder bile should be zero
Secondary Outcomes
- Amylase and Lipase Values in Normal Gallbladders(24 hours)
- Amylase and Lipase Values in Gallbladders With Cholelithiasis(24 hours)
- Normal Operative Cholangiography(24 hours)
- Normal Preoperative Serum Values of Amylase and Lipase(24 hours)