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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Participants Whose yearly Rebleeding times Decreased From Baseline by ≥ 50%
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Participants Whose yearly Rebleeding times Decreased From Baseline by ≥ 50%
时间窗: up to 3 yrs
次要结局
- difference in yearly mean Hemoglobin (Hb) level(up to 3 yrs)
- difference in Total Transfused Red Cell Requirements(up to 3 yrs)
- difference of yearly hospitalization times(up to 3 yrs)
- difference in Blood Transfusions Requirements(up to 3 yrs)
- difference in yearly bleeding Episodes(up to 3 yrs)
- numbers of patients requiring hospitalization(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)
- Difference of patients completely cured(up to 3 yrs)
研究者
Zhizheng Ge
Director of digestive endoscopy centre of Renji hospital
Shanghai Jiao Tong University School of Medicine