the Efficiency of Endoscopic Treatment for Recurrent Small Intestinal Bleeding Due to Gastrointes… (NCT02716545) | Clinical Trial Compass
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the Efficiency of Endoscopic Treatment for Recurrent Small Intestinal Bleeding Due to Gastrointestinal Vascular Malformation
China300 participantsStarted 2016-03
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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 d…
What they're measuring
1
Participants Whose yearly Rebleeding times Decreased From Baseline by ≥ 50%
Timeframe: up to 3 yrs
Trial details
NCT IDNCT02716545
SponsorShanghai Jiao Tong University School of Medicine