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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic Intervention Group | Experimental | Endoscopic therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| balloon assisted enteroscopy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Participants Whose yearly Rebleeding times Decreased From Baseline by ≥ 50% | up to 3 yrs |
| Measure | Description | Time Frame |
|---|---|---|
| Difference of patients completely cured | 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 | up to 3 yrs |
| difference in Blood Transfusions Requirements |
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Inclusion Criteria:
The patients should sign informed consent and be informed of the specific trial plan;
Exclusion Criteria:
patients associated with varicosity due to cirrhosis of the liver; Or patients with uncontrolled hypertension, hyperglycemia, or other severe diseases;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhizheng Ge, MD, Ph D | Contact | zhizhengge@aliyun.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200127 | China |
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|
| up to 3 yrs |
| difference in Total Transfused Red Cell Requirements | up to 3 yrs |
| difference in yearly bleeding Episodes | up to 3 yrs |
| difference in yearly mean Hemoglobin (Hb) level | up to 3 yrs |
| numbers of patients requiring hospitalization | up to 3 yrs |
| difference of yearly hospitalization times | up to 3 yrs |
| difference of the number of days in hospital yearly | up to 3 yrs |
| difference in mean iron requirements | up to 3 yrs |
|