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

NCT03976739 | Completed

• 1 other identifier: KY20191026-F-1
• Study Type: observational
• Target: 1,162
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

gastric cancer; helicobacter pylori; precancerous lesion; bile reflux

Outcome Measures

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

  up to 6 months

Secondary Outcomes (1)

• the risk factors of primary bile reflux gastritis

  up to 6 months

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients are from several centers all around the China

You may qualify if:

• Age 18 to 75 years old, gender is not limited;
• patients with upper abdominal pain, abdominal distension, belching, anorexia, early satiety, hiccup, acid reflux, upper abdomen burning sensation and other upper gastrointestinal symptoms;
• Voluntary acceptance of Hp testing;
• Voluntary acceptance of the endoscopy and pathological biopsy.

You may not qualify if:

• had undergone upper gastrointestinal surgery;
• Previous diagnosis of esophageal cancer;
• Previous diagnosis of gastric cancer;
• Previous diagnosis of MALT lymphoma;
• pregnant and lactating women;
• Those with mental disorders;
• Refusal to sign the informed consent form.

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (1)

Xijing Hosipital of Digestive Disease

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Stomach Neoplasms; Bile Reflux

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Biliary Tract Diseases; Duodenogastric Reflux

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: June 6, 2019
• Study Start: June 17, 2019
• Primary Completion: October 30, 2019
• Study Completion: December 31, 2019
• Last Updated: August 12, 2020

Record last verified: 2019-05

Locations

CN (1)