Gastrointestinal BleedingNCT01821326
Risk Factors for Rebleeding in Patients With Obscure Gastrointestinal Bleeding
An observational study of Gastrointestinal Bleeding, run by Shanghai Jiao Tong University School of Medicine.
Trial summary
The investigators investigated the rebleeding rate the risk factors for rebleeding after long-term follow-up (≥12 months) in patients who underwent capsule endoscopy for obscure gastrointestinal bleeding. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Gastrointestinal Bleeding
- How many people
- 339 participants
- Where
- No sites listed yet
- Study dates
- Jun 2002to Jan 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent CE in Shanghai Renji Hospital ( China )from June 2002 to January 2012 for OGIB
Who may be able to join
- Patients who underwent capsule endoscopy in Shanghai Renji Hospital(China) from June 2002 to January 2012 for obscure gastrointestinal bleeding
Who cannot join
- patients who did not undergo a gastroscopy and colonoscopy performed before capsule endoscopy examination; and
- patients with follow-up examination for other know clinical diseases.
About this study
The investigators investigated the rebleeding rate the risk factors for rebleeding after long-term follow-up (≥12 months) in patients who underwent capsule endoscopy for obscure gastrointestinal bleeding.
- Conditions
- Gastrointestinal Bleeding
- Keywords
- capsule endoscopy, obscure gastrointestinal bleeding, rebleeding, risk factors
- Medical subject headings
- Gastrointestinal Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Rebleeding Rate
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2013 (estimated)
- Study startJun 2002
- Primary completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastrointestinal BleedingStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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
- Time perspective
- Retrospective
- Enrolment
- 339 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhizheng Ge, Shanghai Jiao Tong University School of Medicine
- Investigators
- Zhizheng Ge, M.D. PhD., Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821326
- Sponsor's protocol ID
- rjyyxhk0831
- Status last verified
- Nov 2016
- First submitted
- 23 Mar 2013
- Last updated
- 25 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Rebleeding in Patients With Obscure Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT01821326
- Acronym / sponsor ID
- rjyyxhk0831
- Conditions
- Gastrointestinal Bleeding
- Keywords
- capsule endoscopy, obscure gastrointestinal bleeding, rebleeding, risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Jun 2002
- Primary completion
- Jan 2013 (actual)
- First posted
- 1 Apr 2013 (estimated)
- Results
- Posted 25 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators investigated the rebleeding rate the risk factors for rebleeding after long-term follow-up (≥12 months) in patients who underwent capsule endoscopy for obscure gastrointestinal bleeding.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent CE in Shanghai Renji Hospital ( China )from June 2002 to January 2012 for OGIB
Key inclusion criteria (1 listed)
- Patients who underwent capsule endoscopy in Shanghai Renji Hospital(China) from June 2002 to January 2012 for obscure gastrointestinal bleeding
Key exclusion criteria (2 listed)
- patients who did not undergo a gastroscopy and colonoscopy performed before capsule endoscopy examination; and
- patients with follow-up examination for other know clinical diseases.
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
Rebleeding Rate
Time frame: 10 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Zhizheng Ge, M.D. PhD. principal investigator
RenJi Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Bleeding, run by Shanghai Jiao Tong University School of Medicine.
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 1 inclusion and 2 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 25 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 25 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rebleeding Rate (time frame: 10 years). 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 25 Jan 2017; AzTrials last refreshed its copy on 7 Nov 2026.