Pancreaticobiliary Reflux in Patients Without Cholelithiasis

Cirujanos la Serena

Status: Completed

Conditions: Pancreaticobiliary Reflux

Treatments: Procedure: Gallbladder bile sampling and intraoperative cholangiography

Study type: Observational

Funder types: Other

Identifiers

NCT00890201

HLS-2704009-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 197 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

197 participants in 2 patient groups

Normal Gallbladder

Description:

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.

Treatment:

Procedure: Gallbladder bile sampling and intraoperative cholangiography

Gallbladder with gallstones

Description:

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.

Treatment:

Procedure: Gallbladder bile sampling and intraoperative cholangiography