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Pancreaticobiliary Reflux in Patients Without Cholelithiasis

Completed
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
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Normal GallbladderGallbladder bile sampling and intraoperative cholangiographyPatients 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 gallstonesGallbladder bile sampling and intraoperative cholangiographyPatients 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
NameTimeMethod
Amylase and Lipase Values in Gallbladder Bile24 hours

Normal values of lipase and amylase in gallbladder bile should be zero

Secondary Outcome Measures
NameTimeMethod
Amylase and Lipase Values in Normal Gallbladders24 hours
Amylase and Lipase Values in Gallbladders With Cholelithiasis24 hours
Normal Operative Cholangiography24 hours
Normal Preoperative Serum Values of Amylase and Lipase24 hours

Trial Locations

Locations (1)

Hospital de La Serena

🇨🇱

La Serena, Iv Region, Chile

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