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CompletedNCT03976739Updated Aug 12, 2020

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

An observational study in Bile Reflux Gastritis, Gastric Cancer and Helicobacter Pylori Infection, sponsored by Xijing Hospital of Digestive Diseases. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-12.

Sponsored by Xijing Hospital of Digestive Diseases · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
1,162
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • gastric cancer; helicobacter pylori; precancerous lesion; bile reflux
03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's enrollment of 1,162 is above the median of 274 across 670 observational studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Xijing Hospital of Digestive Diseases is the lead sponsor of 80 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

patients are from several centers all around the China

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

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.
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
1,162 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: up to 6 months

Secondary outcomes

  1. 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

    Time frame: up to 6 months

07

Study locations

1 site
  • Xijing Hosipital of Digestive Disease
    Xi'an, Shaanxi 710032, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03976739
Lead sponsor
Xijing Hospital of Digestive Diseases
Responsible party
Yongquan Shi (Principal Investigator, Clinical Professor, Xijing Hospital of Digestive Diseases) — Principal investigator
First posted
Jun 6, 2019
Start date
Jun 17, 2019
Primary completion
Oct 30, 2019
Completion
Dec 31, 2019
Last update
Aug 12, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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