Does Cholecystectomy Increase the Esophageal Alkaline Reflux? Evaluation by Impedance-pH Technique

This study has been completed.
Sponsor:
Information provided by:
Istanbul University
ClinicalTrials.gov Identifier:
NCT01047085
First received: January 11, 2010
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

Publications with different conclusions are available with regard to the correlations between the cholecystolithiasis, cholecystectomy and gastroesophageal reflux disease (GERD). In this study, the controversial relationship between cholecystolithiasis, cholecystectomy and GERD is discussed through the impedance pH method which started to be used in recent years, a method indicating the gas and liquid (acid and non-acid) gastroesophageal reflux (GER) and esophageal clearance time.


Condition Intervention
Cholecystolithiasis
Cholecystectomy
Gastroesophageal Reflux
Procedure: impedance pH measurement

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Does Cholecystectomy Increase the Esophageal Alkaline Reflux? Evaluation by Impedance-pH Technique

Resource links provided by NLM:


Further study details as provided by Istanbul University:

Enrollment: 24
Study Start Date: April 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control group
Control group: Impedance pH measurements of healthy controls are performed to compare the results with the study group.
Procedure: impedance pH measurement
Impedance pH measurement: Impedance-pH is a recently developed technique used to monitor all kinds of reflux (gas, liquid, acides and non-acides), reflux level and the clearance period of the esophagus.
Experimental: Study group
Study group: Pre-operative and post-operative impedance pH measurements are performed to patients in which elective cholecystectomy is planned.
Procedure: impedance pH measurement
Impedance pH measurement: Impedance-pH is a recently developed technique used to monitor all kinds of reflux (gas, liquid, acides and non-acides), reflux level and the clearance period of the esophagus.

Detailed Description:

Gallstones are observed among 6-20% of the people in the world and 2 folds in women than in men. The symptomatic treatment of the cholecystolithiasis is the cholecystectomy and it is known that every year in United States of America (USA) more than 750.000 cholecystectomy operations are performed. Usually applied to laparoscopic surgery, in experienced hands with great success, but the application is not without problems and can cause the condition called postcholecystectomy syndrome. Postcholecystectomy syndrome is a heterogeneous condition and may occur depending on many causes. One of the suggested reasons is the increasing gastroesophageal reflux diseases (GER). Publications indicating the increase of GER after cholecystectomy are available.

Relationship between the gallbladder stone and the reflux; whether reflux increases after cholecystectomy is a controversial subject. In current studies, the assessments of reflux are performed by different techniques such as interview, endoscopy and 24-hour pH monitoring. These evaluations are often useful in detecting acid reflux. Whereas it is known that after cholecystectomy alkaline bile reflux may be determined in stomach. Therefore, the determination of bile reflux in esophagus after cholecystectomy is also possible. This situation may be important in terms of esophagus adenocarcinoma, because the esophagus adenocarcinoma generally develops in the basis of Barrett's esophagus and alkaline reflux is accepted to contribute to developing Barrett's esophagus (13).

Bile reflux into the stomach is reported in a rate of 30-100% after stomach surgery and 80-90% after gallbladder surgery. Even though bile reflux is observed in such a high percentage, not every kind bile reflux will damage the gastric and esophageal mucosa. Leaking up into the stomach (reflux), the bile and pancreatic secretions presented in the duodenum content mix up with the hydrochloric acid and pepsin presented in stomach, and thereby damage occurs in the gastric and esophageal mucosa. The continuation of this interaction may develop gastritis, esophagitis.

The increase of alkaline reflux and its importance are known in the development of Barrett's esophagus, which is a component of GER spectrum and which can develop into adenocarcinoma. As a result of research performed on people with cholecystectomy, the risk of developing esophageal cancer has been shown to increase moderately. This is probably duo to the reflux of the bile found in the duodenum content through the esophagus. Nowadays only acid reflux can be determined by the widely used 24-hour pH-meter. The bile-sensitive Bilitec is a difficult method to implement and it is not widely used. Impedance-pH is a recently developed technique used to monitor all kinds of reflux (gas, liquid, acides and non-acides), reflux level and the clearance period of the esophagus.

The purpose of this study: To investigate the relationship between GER, cholecystolithiasis and cholecystectomy by using the Impedance-pH method.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants 20-80 years old, who would undergo cholecystectomy in the General Surgery Clinic due to gallbladder stones, who did not present GER, gastrointestinal system disorders, serious co-morbidities and who agreed to participate in the study were recruited as patients.
  • 10 healthy volunteers 20-80 years old, who did not have peptic ulcer, GER, gallbladder stones, cholestatic liver diseases and who agreed to participate in the study were recruited in the control group.

Exclusion Criteria:

  • Those who cannot have Impedance-esophageal pHmeter examinations
  • Patients with a history of a previous stomach or esophageal surgeries
  • Those with malignancies
  • Those with severe cardiopulmonary disease
  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Ahmet Uyanikoglu, Istanbul University, Istanbul Faculty of Medicine
ClinicalTrials.gov Identifier: NCT01047085     History of Changes
Other Study ID Numbers: Impedance
Study First Received: January 11, 2010
Last Updated: January 11, 2010
Health Authority: Turkey: The of Ministry of Health

Keywords provided by Istanbul University:
cholecystolithiasis
cholecystectomy
gastroesophageal reflux
impedance pH
The relationship between cholecystolithiasis, cholecystectomy and gastroesophageal reflux by impedance pH-method.

Additional relevant MeSH terms:
Gastroesophageal Reflux
Cholecystolithiasis
Cholelithiasis
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 16, 2014