Pancreaticobiliary Reflux in Patients Without Cholelithiasis

December 1, 2010 updated by: Cirujanos la Serena

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

197

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Iv Region
      • La Serena, Iv Region, Chile, IV REGION
        • Hospital de La Serena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  1. Patients with gallstones (symptomatic cholelithiasis) submitted to elective surgery.
  2. Patients without gallstones submitted to elective surgery for benign or malignant gastroesophageal diseases

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal Gallbladder

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

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

Other Names:
  • Measurement of pancreaticobiliary reflux
Gallbladder with gallstones

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

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

Other Names:
  • Measurement of pancreaticobiliary reflux

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Amylase and Lipase Values in Normal Gallbladders
Time Frame: 24 hours
24 hours
Amylase and Lipase Values in Gallbladders With Cholelithiasis
Time Frame: 24 hours
24 hours
Normal Operative Cholangiography
Time Frame: 24 hours
24 hours
Normal Preoperative Serum Values of Amylase and Lipase
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cirujanos la Serena

Investigators

  • Principal Investigator: MARCELO A BELTRAN, M.D., Hospital de La Serena

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

April 28, 2009

First Submitted That Met QC Criteria

April 28, 2009

First Posted (Estimate)

April 29, 2009

Study Record Updates

Last Update Posted (Estimate)

December 17, 2010

Last Update Submitted That Met QC Criteria

December 1, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HLS-2704009-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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