- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02716545
the Efficiency of Endoscopic Treatment for Recurrent Small Intestinal Bleeding Due to Gastrointestinal Vascular Malformation
September 19, 2019 updated by: Zhizheng Ge, Shanghai Jiao Tong University School of Medicine
the Efficiency of Endoscopic Treatment for Recurrent Small Intestinal Bleeding Due to Gastrointestinal Vascular Malformation: the Study of the Bleeding Risks Stratification Model and Endoscopic Treatment
Gastrointestinal vascular malformation (GIVM), which is an important cause of acute or chronic gastrointestinal bleeding, consequently is in dire of effective treatment.
The investigators' previous study first confirmed thalidomide treatment of GIVM bleeding was safe and effective.
This trial intends to investigate the efficiency of endoscopic intervention to the hemorrhage due to GIVM.
What more, the research tends to suggest standardizing clinical paths for small bowel bleeding due to GIVM.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
This multi-institutional clinical trial investigates the efficacy of endoscopic intervention to the recurrent small intestinal hemorrhage due to GIVM.
Patients with recurrent bleeding (>2 times for one year) will undergo balloon assisted enteroscopy and be treated with endoscopic therapy if necessary.
The hierarchical primary endpoints were the difference in yearly Bleeding times, followed (if significant) by the difference in Blood Transfusions, Total Transfused Red Cell Requirements, yearly bleeding Episodes, Bleeding Duration, yearly average Hemoglobin (Hb) level, hospitalization and iron requirement.
The study will be done at 10 centers in China.
Study Type
Interventional
Enrollment (Anticipated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zhizheng Ge, MD, Ph D
- Email: zhizhengge@aliyun.com
Study Locations
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Shanghai
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Shanghai, Shanghai, China, 200127
- Recruiting
- Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine
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Contact:
- Zhizheng Ge, MD. Ph.D
- Phone Number: 18621890923
- Email: zhizhengge@aliyun.com.cn
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Principal Investigator:
- Zhizheng Ge, MD. Ph.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
The patients should sign informed consent and be informed of the specific trial plan;
- The patients should have the China nationality;
- The patients should be aged from 18 to 70 years old, male or female;
- The intestinal vascular lesions should be found by capsule endoscopy, and / or balloon assisted enteroscopy; OR the patients should present with persistent and recurrent bleeding, while the bleeding lesions are unable to be located by all these examinations mention above;
- The patients should present with persistent and recurrent bleeding (>=2 times for one year);
- Hb levels should decreased 10% lower than baseline.
- The patient is willing to comply with the instructions and have the ability to complete the study of research program.
Exclusion Criteria:
patients associated with varicosity due to cirrhosis of the liver; Or patients with uncontrolled hypertension, hyperglycemia, or other severe diseases;
- patients with a history of severe peripheral neuropathy, seizures, rheumatoid immune disease, or thromboembolic disease;
- patients with indications which should constantly use non-steroidal anti-inflammatory drugs, anticoagulants and anti-platelet or acetyl salicylic acid preparation, ginkgo, Echinacea, Chinese herbal medicine composition, other anti-angiogenesis drugs;
- patients with malignant or severe heart disease (uncontrolled angina and/or myocardial infarction, congestive heart failure within 3 months before recruiting, etc.), lung disease (respiratory failure), kidney, pancreatic, liver disease or other diseases that researchers evaluated as affect the judgment of the treatment;
- previously small intestinal bowel resection surgery;
- serious life-threatening gastrointestinal bleeding requiring immediate surgical treatment;
- alcohol and/or drug abuse, addiction or rely on) or the doctor determine compliance claim;
- patients had been recruited into other clinical research within 6 months;
- personnel related to this study;
- patients have no legal behavior ability or self-knowledge; Or patients refuse into groups.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Endoscopic Intervention Group
Endoscopic therapy
|
Patients with recurrent bleeding (>2 times for one year) will undergo balloon assisted enteroscopy and be treated with endoscopic therapy if necessary.
Currently available endoscopic modalities are argon laser, bipolar electrocoagulation (BiCAP), band ligation, cryotherapy, radiofrequency ablation and argon plasma coagulation (APC).
Among these options, APC is the most promising.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Participants Whose yearly Rebleeding times Decreased From Baseline by ≥ 50%
Time Frame: up to 3 yrs
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up to 3 yrs
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference of patients completely cured
Time Frame: up to 3 yrs
|
The cessation of bleeding was defined as repeated negative fecal occult blood test (FOBT) (monoclonal colloidal gold color technology) during our observation period.
Rebleeding was defined based on a positive FOBT at any visit after treatment
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up to 3 yrs
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difference in Blood Transfusions Requirements
Time Frame: up to 3 yrs
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up to 3 yrs
|
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difference in Total Transfused Red Cell Requirements
Time Frame: up to 3 yrs
|
up to 3 yrs
|
|
difference in yearly bleeding Episodes
Time Frame: up to 3 yrs
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up to 3 yrs
|
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difference in yearly mean Hemoglobin (Hb) level
Time Frame: up to 3 yrs
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up to 3 yrs
|
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numbers of patients requiring hospitalization
Time Frame: up to 3 yrs
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up to 3 yrs
|
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difference of yearly hospitalization times
Time Frame: up to 3 yrs
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up to 3 yrs
|
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difference of the number of days in hospital yearly
Time Frame: up to 3 yrs
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up to 3 yrs
|
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difference in mean iron requirements
Time Frame: up to 3 yrs
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up to 3 yrs
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2016
Primary Completion (Anticipated)
December 1, 2019
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
March 11, 2016
First Submitted That Met QC Criteria
March 22, 2016
First Posted (Estimate)
March 23, 2016
Study Record Updates
Last Update Posted (Actual)
September 23, 2019
Last Update Submitted That Met QC Criteria
September 19, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- rj(2015)088K-b
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gastrointestinal Vascular Malformation
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