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出境医 / 临床实验 / Study on the Effect of Bile Reflux on Gastric Cancer and Its Precancerous Lesions: a Cross-sectional Study.
Study on the Effect of Bile Reflux on Gastric Cancer and Its Precancerous Lesions: a Cross-sectional Study.
Study Description
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.
Study Design
| 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 |
Arms 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
|
Outcome Measures
Primary Outcome Measures :
- 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 :
- 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
Eligibility Criteria
| 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:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Locations
| China, Shaanxi | |
| Xijing Hosipital of Digestive Disease | |
| Xi'an, Shaanxi, China, 710032 | |
Sponsors and Collaborators
Xijing Hospital of Digestive Diseases
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 27, 2019 | ||||
| First Posted Date | June 6, 2019 | ||||
| Last Update Posted Date | August 12, 2020 | ||||
| Actual Study Start Date | June 17, 2019 | ||||
| Actual Primary Completion Date | October 30, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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
|
||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
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
|
||||
| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Study on the Effect of Bile Reflux on Gastric Cancer and Its Precancerous Lesions: a Cross-sectional Study. | ||||
| Official Title | Study on the Effect of Bile Reflux on Gastric Cancer and Its Precancerous Lesions: a Multiple Center, Cross-sectional Study. | ||||
| 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. | ||||
| 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 | ||||
| Study Design | Observational Model: Other Time Perspective: Cross-Sectional |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | patients are from several centers all around the China | ||||
| Condition |
|
||||
| Intervention | Not Provided | ||||
| Study Groups/Cohorts |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
1162 | ||||
| Original Estimated Enrollment |
5000 | ||||
| Actual Study Completion Date | December 31, 2019 | ||||
| Actual Primary Completion Date | October 30, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender |
|
||||
| Ages | 18 Years to 75 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03976739 | ||||
| Other Study ID Numbers | KY20191026-F-1 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Yongquan Shi, Xijing Hospital of Digestive Diseases | ||||
| Study Sponsor | Xijing Hospital of Digestive Diseases | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Xijing Hospital of Digestive Diseases | ||||
| Verification Date | May 2019 | ||||
