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

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ClinicalTrials.gov Identifier: NCT03976739
Recruitment Status : Completed
First Posted : June 6, 2019
Last Update Posted : August 12, 2020
Sponsor:
Information provided by (Responsible Party):
Yongquan Shi, 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.

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

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.

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Study Type : Observational
Actual Enrollment : 1162 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Study on the Effect of Bile Reflux on Gastric Cancer and Its Precancerous Lesions: a Multiple Center, Cross-sectional Study.
Actual Study Start Date : June 17, 2019
Actual Primary Completion Date : October 30, 2019
Actual Study Completion Date : December 31, 2019


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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients are from several centers all around the China
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03976739


Locations
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China, Shaanxi
Xijing Hosipital of Digestive Disease
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Xijing Hospital of Digestive Diseases
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Responsible Party: Yongquan Shi, Principal Investigator, Clinical Professor, Xijing Hospital of Digestive Diseases
ClinicalTrials.gov Identifier: NCT03976739    
Other Study ID Numbers: KY20191026-F-1
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yongquan Shi, Xijing Hospital of Digestive Diseases:
gastric cancer; helicobacter pylori; precancerous lesion; bile reflux
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastroesophageal Reflux
Gastritis
Bile Reflux
Metaplasia
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastroenteritis
Pathologic Processes
Biliary Tract Diseases
Duodenogastric Reflux