Gastroesophageal Reflux Clinical Trial
Official title:
Does Cholecystectomy Increase the Esophageal Alkaline Reflux? Evaluation by Impedance-pH Technique
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.
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.
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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