Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01047085
Other study ID # Impedance
Secondary ID
Status Completed
Phase N/A
First received January 11, 2010
Last updated January 11, 2010
Start date April 2008
Est. completion date May 2009

Study information

Verified date March 2008
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority Turkey: The of Ministry of Health
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date May 2009
Est. primary completion date May 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 80 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University
See also
  Status Clinical Trial Phase
Recruiting NCT05561179 - Hyaluronic Acid in Patients With Gastroesophageal Reflux Disease N/A
Withdrawn NCT02213887 - Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications Phase 4
Completed NCT01946971 - Lansoprazole in Preterm Infants With Gastroesophageal Reflux (GER) Phase 1/Phase 2
Recruiting NCT01825473 - Study of Erythromycin in GER-Associated Apnea of the Newborn N/A
Completed NCT00614536 - Study of Changes in Reflux Symptoms and Reflux Finding Score According to Rabeprazole Treatment Period Phase 4
Completed NCT00373997 - Esophageal and Laryngeal Tissue Changes in Patients Suspected of Having Laryngopharyngeal Reflux Phase 4
Completed NCT00365300 - Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD) Phase 3
Completed NCT00284908 - Dose-Effect of S-Tenatoprazole-Na(STU-Na) 30 mg, 60 mg, 90 mg and 120 mg in Healthy Volunteers Phase 1
Completed NCT00141960 - Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease Phase 2/Phase 3
Completed NCT00215787 - Investigation of the Association Between Nasal Polyposis and Extraesophageal Reflux Disease N/A
Completed NCT01167543 - Relationship and Pathophysiology of Gastroesophageal Reflux and Dental/Periodontal Disease N/A
Completed NCT00567021 - German PMS Trial (AWB) to Evaluate Therapy in Reflux Disease and NSAR-Symptoms N/A
Completed NCT00291746 - Validation of RDQ Questionnaire Phase 4
Completed NCT00226044 - Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants. Phase 3
Completed NCT01048840 - Natural History of Gastroesophageal Reflux (GER) in Children < 12 Years of Age
Completed NCT00181805 - Natural History of Gastroesophageal Reflux (GER) in Children and Adolescents
Terminated NCT01281553 - A Study of Cisapride in Patients With Symptomatic Gastro-Oesophageal Reflux Disease Phase 4
Completed NCT05486169 - Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy N/A
Completed NCT04034017 - Gastroesophageal Reflux Disease Among College Students
Terminated NCT03226054 - Determining Risk Factors for Successful PPI Weaning N/A