Endoscopic Tri-Modal Imaging to Distinguish Functional Dyspepsia From Reflux Disease

Gastroesophageal Reflux Disease Clinical Trial

Official title:

The Role of Endoscopic Tri-Modal Imaging in Distinguishing Functional Dyspepsia From Reflux Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02685150
• Other study ID #: S2015-086-02
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: June 2018

Study information

• Verified date: July 2018
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Endoscopic Tri-Modal Imaging which combines Narrow-band Imaging(NBI), Autofluorescence Imaging (AFI) and White-light Imaging (WLI) could be used to identify the indistinct changes in the gut caused by reflux disease,either acid reflux or bile reflux, which make it possible to differentiate reflux disease from functional dyspepsia (FD).

Description:

Functional dyspepsia (FD) and acid/bile reflux disease are common. These diseases share similar clinical manifestations. Individuals with functional dyspepsia (FD) often present upper abdominal pain or discomfort, bloating, early satiety, loss of appetite, and no organic factors underlie it. Individuals suffering from acid/bile reflux disease often complain heartburn, upper abdominal burning or discomfort. What is more, there are always no specific changes on traditional endoscopy that can be used to differentiate these diseases (except erosive esophagitis). Though proton-pump inhibitor (PPI) test is frequently applied to confirm the diagnosis of acid reflux disease, but certain amounts of individuals with gastroesophageal reflux disease (GERD) do not show favorable response to PPI test. In order to make a distinction of these diseases, esophageal pH-metry is needed, however it is not always available in most clinics. Recent data showed that new endoscopic technology such as Endoscopic Tri-Modal Imaging could demonstrate indistinct lesions caused by GERD which are not detectable by standard endoscopy, subsequently improve endoscopic diagnosis of these diseases. In addition, simultaneous analysis of gastric juice can help to determine whether bile reflux is present or not. As it is known, pathologic refluxes underlie not functional dyspepsia but acid/bile reflux disease. Hence, it is hypothesized that Endoscopic Tri-Modal Imaging in combination with simultaneous analysis of gastric juice could be used to differentiate functional dyspepsia from acid/bile reflux disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• symptoms suggestive of GERD or dyspepsia.

• Presence of symptom for longer than 6 month

• Provision of written informed consent

Exclusion Criteria:

• Any known upper GI disease, other than reflux esophagitis

• Active or healing gastroduodenal ulcer (except scars)

• History of esophageal or gastric surgery.

• Clinically significant heart, lung, liver or kidney disease

• Allergy to proton-pump inhibitor

• Pregnancy

Related Conditions & MeSH terms

• Bile Reflux
• Dyspepsia
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Device:
• Endoscopic Tri-Modal Imaging
Endoscope that combines white light imaging (WLI) with autofluorescence imaging (AFI) and narrow band imaging (NBI).

Drug:
• Omeprazole
Omeprazole is one kind of proton-pump inhibitors. All participants undergo standard proton-pump inhibitor (PPI) tests for two weeks with Omeprazole, 20mg twice a day.

Other:
• Analysis of gastric juice
Analysis of gastric juice including routine, biochemical and microbiological analysis.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

Talley NJ. Functional (non-ulcer) dyspepsia and gastroesophageal reflux disease: one not two diseases? Am J Gastroenterol. 2013 May;108(5):775-7. doi: 10.1038/ajg.2013.102. — View Citation

Wang W, Uedo N, Yang Y, Peng L, Bai D, Lu Z, Fan K, Wang J, Wang X, Zhao Y, Yu Z. Autofluorescence imaging endoscopy for predicting acid reflux in patients with gastroesophageal reflux disease. J Gastroenterol Hepatol. 2014;29(7):1442-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numbers of participants with abnormal endoscopic findings and positive Omeprazole tests	Numbers of participants with abnormal endoscopic findings are used to calculate the diagnostic Value of Endoscopic Tri-Modal Imaging in Distinguishing Functional Dyspepsia and Reflux Disease, including specificity, sensitivity and accuracy.	one month