Bile Reflux GastritisNCT03976739
Study on the Effect of Bile Reflux on Gastric Cancer and Its Precancerous Lesions: a Cross-sectional Study.
An observational study of Bile Reflux Gastritis and Gastric Cancer, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Bile Reflux Gastritis, Gastric Cancer, Helicobacter Pylori Infection
- How many people
- 1,162 participants
- Where
- 1 siteChina
- Study dates
- 17 Jun 2019to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients are from several centers all around the China
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Bile Reflux Gastritis, Gastric Cancer, Helicobacter Pylori Infection, Intestinal Metaplasia, Precancerous Lesions
- Keywords
- gastric cancer; helicobacter pylori; precancerous lesion; bile reflux
- Medical subject headings
- Stomach Neoplasms, Bile Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start17 Jun 2019
- Primary completion30 Oct 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bile Reflux GastritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongquan Shi, Xijing Hospital of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976739
- Sponsor's protocol ID
- KY20191026-F-1
- Status last verified
- May 2019
- First submitted
- 27 May 2019
- Last updated
- 12 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effect of Bile Reflux on Gastric Cancer and Its Precancerous Lesions: a Multiple Center, Cross-sectional Study.
- ClinicalTrials.gov ID
- NCT03976739
- Acronym / sponsor ID
- KY20191026-F-1
- Conditions
- Bile Reflux Gastritis, Gastric Cancer, Helicobacter Pylori Infection, Intestinal Metaplasia, Precancerous Lesions
- Keywords
- gastric cancer; helicobacter pylori; precancerous lesion; bile reflux
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,162 participants (actual)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 6 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients are from several centers all around the China
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- had undergone upper gastrointestinal surgery;
- Previous diagnosis of esophageal cancer;
- Previous diagnosis of gastric cancer;
- Previous diagnosis of MALT lymphoma;
- pregnant and lactating women;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
the risk factors of primary bile reflux gastritis
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bile Reflux Gastritis and Gastric Cancer, run by Xijing Hospital of Digestive Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
corelation between the bile reflux and gastric mucosa diseases (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.