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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03976739
• Other study ID #: KY20191026-F-1
• Status: Completed
• Start date: June 17, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2019
• Source: Xijing Hospital of Digestive Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1162
• Est. completion date: December 31, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bile Reflux
• Bile Reflux Gastritis
• Gastric Cancer
• Gastritis
• Gastroesophageal Reflux
• Helicobacter Pylori Infection
• Intestinal Metaplasia
• Metaplasia
• Precancerous Lesions
• Stomach Neoplasms

Locations

Country	Name	City	State
China	Xijing Hosipital of Digestive Disease	Xi`an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital of Digestive Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	corelation between the bile reflux and gastric mucosa diseases	we evaluate the corelation between the bile reflux and gastric mucosa diseases according to the histopathological results and the scales the patients finished	up to 6 months
Secondary	the risk factors of primary bile reflux gastritis	we evaluate the the risk factors of primary bile reflux gastritis according to the scales and endoscopical results	up to 6 months