Pancreaticobiliary Reflux in Patients Without Cholelithiasis

This study has been completed.
Sponsor:
Information provided by:
Cirujanos la Serena
ClinicalTrials.gov Identifier:
NCT00890201
First received: April 28, 2009
Last updated: December 1, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention
Pancreaticobiliary Reflux
Procedure: Gallbladder bile sampling and intraoperative cholangiography

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Is Pancreaticobiliary Reflux in Patients With Cholelithiasis and Without Cholelithiasis a Normal Phenomenon?

Resource links provided by NLM:


Further study details as provided by Cirujanos la Serena:

Primary Outcome Measures:
  • Amylase and Lipase Values in Gallbladder Bile [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Normal values of lipase and amylase in gallbladder bile should be zero


Secondary Outcome Measures:
  • Amylase and Lipase Values in Normal Gallbladders [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Amylase and Lipase Values in Gallbladders With Cholelithiasis [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Normal Operative Cholangiography [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Normal Preoperative Serum Values of Amylase and Lipase [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 197
Study Start Date: January 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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 Name: Measurement of pancreaticobiliary reflux

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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890201

Locations
Chile
Hospital de La Serena
La Serena, Iv Region, Chile, IV REGION
Sponsors and Collaborators
Cirujanos la Serena
Investigators
Principal Investigator: MARCELO A BELTRAN, M.D. HOSPITAL DE LA SERENA
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MARCELO A. BELTRAN, M.D., HOSPITAL DE LA SERENA
ClinicalTrials.gov Identifier: NCT00890201     History of Changes
Other Study ID Numbers: HLS-2704009-02
Study First Received: April 28, 2009
Results First Received: July 27, 2009
Last Updated: December 1, 2010
Health Authority: Chile: Instituto de Salud Pública de Chile

Keywords provided by Cirujanos la Serena:
Pancreaticobiliary reflux
Normal pancreaticobiliary junction
Gallstones
Cholelithiasis
Cholecystectomy

Additional relevant MeSH terms:
Gastroesophageal Reflux
Cholelithiasis
Cholecystolithiasis
Gallstones
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Biliary Tract Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 18, 2014