Pancreaticobiliary Reflux in Patients Without Cholelithiasis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Is Pancreaticobiliary Reflux in Patients With Cholelithiasis and Without Cholelithiasis a Normal Phenomenon?

Conditions
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Pancreaticobiliary Reflux

Intervention / Treatment
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* Procedure: Gallbladder bile sampling and intraoperative cholangiography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal Gallbladder<br>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. | Procedure: Gallbladder bile sampling and intraoperative cholangiography<br>* Interventions were exactly similar for both groups, and that is how it was intended to be: Gallbladder bile sampling: Sample 5 cc of gallbladder bile after the cystic duct has been clipped or ligated. Intraoperative cholangiography: Perform cholangiography before the cholecystectomy is finished<br>* Other names: Measurement of pancreaticobiliary reflux;|
| Gallbladder with gallstones<br>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. | Procedure: Gallbladder bile sampling and intraoperative cholangiography<br>* Interventions were exactly similar for both groups, and that is how it was intended to be: Gallbladder bile sampling: Sample 5 cc of gallbladder bile after the cystic duct has been clipped or ligated. Intraoperative cholangiography: Perform cholangiography before the cholecystectomy is finished<br>* Other names: Measurement of pancreaticobiliary reflux;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amylase and Lipase Values in Gallbladder Bile | Normal values of lipase and amylase in gallbladder bile should be zero | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreaticobiliary reflux, Normal pancreaticobiliary junction, Gallstones, Cholelithiasis, Cholecystectomy