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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
300
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.
Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGParticipants Whose yearly Rebleeding times Decreased From Baseline by ≥ 50%
Time frame: up to 3 yrs
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
Time frame: up to 3 yrs
difference in Blood Transfusions Requirements
Time frame: up to 3 yrs
difference in Total Transfused Red Cell Requirements
Time frame: up to 3 yrs
difference in yearly bleeding Episodes
Time frame: up to 3 yrs
difference in yearly mean Hemoglobin (Hb) level
Time frame: up to 3 yrs
numbers of patients requiring hospitalization
Time frame: up to 3 yrs
difference of yearly hospitalization times
Time frame: up to 3 yrs
difference of the number of days in hospital yearly
Time frame: up to 3 yrs
difference in mean iron requirements
Time frame: up to 3 yrs
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.