Study on the Effect of Bile Reflux on Gastric Cancer and Its Precancerous Lesions: a Cross-sectional Study.

Completed

• Conditions: Bile Reflux Gastritis; Precancerous Lesions; Intestinal Metaplasia; Gastric Cancer; Helicobacter Pylori Infection

• Registration Number: NCT03976739
• Lead Sponsor: Xijing Hospital of Digestive Diseases

Brief Summary

To explore the effects of bile reflux on gastric cancer and its precancerous lesions, so as to better prevent the occurrence and development of gastric cancer.

Detailed Description

This study was a multicenter cross-sectional study. Patients were consecutively enrolled and divided into gastric cancer group, gastric precancerous lesions group, and chronic gastritis group, according to histopathological results. The bile reflux detection rate and Helicobacter pylori infection status were recorded for each group.

Study Timeline

• Status Verified: 2019-05
• Study First Submitted: 2019-05-27
• Study First Submitted QC: 2019-06-04
• Study First Posted: 2019-06-06
• Study Start: 2019-06-17
• Primary Completion: 2019-10-30
• Study Completion: 2019-12-31
• Last Update Submitted: 2020-08-10
• Last Update Posted: 2020-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1162

Inclusion Criteria

1. Age 18 to 75 years old, gender is not limited;
2. patients with upper abdominal pain, abdominal distension, belching, anorexia, early satiety, hiccup, acid reflux, upper abdomen burning sensation and other upper gastrointestinal symptoms;
3. Voluntary acceptance of Hp testing;
4. Voluntary acceptance of the endoscopy and pathological biopsy.

Exclusion Criteria

1. had undergone upper gastrointestinal surgery;
2. Previous diagnosis of esophageal cancer;
3. Previous diagnosis of gastric cancer;
4. Previous diagnosis of MALT lymphoma;
5. pregnant and lactating women;
6. Those with mental disorders;
7. Refusal to sign the informed consent form.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
corelation between the bile reflux and gastric mucosa diseases	up to 6 months	we evaluate the corelation between the bile reflux and gastric mucosa diseases according to the histopathological results and the scales the patients finished

Secondary Outcome Measures

Name	Time	Method
the risk factors of primary bile reflux gastritis	up to 6 months	we evaluate the the risk factors of primary bile reflux gastritis according to the scales and endoscopical results

Trial Locations

Locations (1)

Xijing Hosipital of Digestive Disease; 🇨🇳 Xi'an, Shaanxi, China