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

NCT ID: NCT03976739

Last Updated: 2020-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1162 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-17

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Bile Reflux Gastritis Gastric Cancer Helicobacter Pylori Infection Intestinal Metaplasia Precancerous Lesions

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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chronic gastritis

patients with chronic non-atrophic gastritis and chronic atrophic gastritis according to histopathological results

No interventions assigned to this group

precancerous lesion

patients with gastric intestinal metaplasia and intraepithelial neoplasia according to histopathological results

No interventions assigned to this group

gastric cancer

patients with gastric cancer according to histopathological results

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Xijing Hospital of Digestive Diseases

OTHER

Sponsor Role lead

Responsible Party

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Yongquan Shi

Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Xijing Hosipital of Digestive Disease

Xi'an, Shaanxi, China

Site Status

Countries

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China

Other Identifiers

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KY20191026-F-1

Identifier Type: -

Identifier Source: org_study_id

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