Pancreaticobiliary Reflux in Patients Without Cholelithiasis
- Conditions
- Pancreaticobiliary Reflux
- Interventions
- Procedure: Gallbladder bile sampling and intraoperative cholangiography
- Registration Number
- NCT00890201
- Lead Sponsor
- Cirujanos la Serena
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 197
- Age older than 15 years of age
- Elective surgery
- Normal intraoperative cholangiography
- Normal preoperative serum amylase and lipase values
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Normal Gallbladder Gallbladder bile sampling and intraoperative cholangiography Patients with normal gallbladder (without gallstones) evidenced by preoperative ultrasonography (and postoperative biopsy) submitted to elective gastroesophageal surgery (gastrectomy for gastric cancer, bariatric surgery or esophageal surgery such as Nissen plicature or miotomy for achalasia). The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography. Preoperative values of amylase and lipase must be normal. Gallbladder with gallstones Gallbladder bile sampling and intraoperative cholangiography Patients submitted to elective cholecystectomy for diseased gallbladders (gallbladder with gallstones evidenced by preoperative ultrasound). The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography and the preoperative amylase and lipase levels must also be normal.
- Primary Outcome Measures
Name Time Method Amylase and Lipase Values in Gallbladder Bile 24 hours Normal values of lipase and amylase in gallbladder bile should be zero
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Hospital de La Serena
🇨🇱La Serena, Iv Region, Chile