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

August 10, 2020 updated by: Yongquan Shi, Xijing Hospital of Digestive Diseases

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

1162

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hosipital of Digestive Disease

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients are from several centers all around the China

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
chronic gastritis
patients with chronic non-atrophic gastritis and chronic atrophic gastritis according to histopathological results
precancerous lesion
patients with gastric intestinal metaplasia and intraepithelial neoplasia according to histopathological results
gastric cancer
patients with gastric cancer according to histopathological results

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
corelation between the bile reflux and gastric mucosa diseases
Time Frame: 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
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the risk factors of primary bile reflux gastritis
Time Frame: up to 6 months
we evaluate the the risk factors of primary bile reflux gastritis according to the scales and endoscopical results
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital of Digestive Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2019

Primary Completion (Actual)

October 30, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

May 27, 2019

First Submitted That Met QC Criteria

June 4, 2019

First Posted (Actual)

June 6, 2019

Study Record Updates

Last Update Posted (Actual)

August 12, 2020

Last Update Submitted That Met QC Criteria

August 10, 2020

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20191026-F-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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