Clinical trial NCT02716545: the Efficiency of Endoscopic Treatment for Recurrent Small Intestinal Bleeding Due to Gastrointestinal Vascular Malformation
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrointestinal Vascular Malformation
Keywords: Gastrointestinal vascular malformation
Endoscopic Therapy
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2016-03-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Participants Whose yearly Rebleeding times Decreased From Baseline by ≥ 50%
timeFrame: up to 3 yrs
Secondary outcomes:
measure: Difference of patients completely cured
timeFrame: up to 3 yrs
measure: difference in Blood Transfusions Requirements
timeFrame: up to 3 yrs
measure: difference in Total Transfused Red Cell Requirements
timeFrame: up to 3 yrs
measure: difference in yearly bleeding Episodes
timeFrame: up to 3 yrs
measure: difference in yearly mean Hemoglobin (Hb) level
timeFrame: up to 3 yrs
measure: numbers of patients requiring hospitalization
timeFrame: up to 3 yrs
measure: difference of yearly hospitalization times
timeFrame: up to 3 yrs
measure: difference of the number of days in hospital yearly
timeFrame: up to 3 yrs
measure: difference in mean iron requirements
timeFrame: up to 3 yrs
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References: