NCT02716545

the Efficiency of Endoscopic Treatment for Recurrent Small Intestinal Bleeding Due to Gastrointestinal Vascular Malformation

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastrointestinal Vascular Malformation

Interventions

Type	Name	Description
DEVICE	balloon assisted enteroscopy	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.

Timeline

• Start date: 2016-03-01
• Primary completion: 2019-12-01
• Completion: 2020-12-01
• First posted: 2016-03-23
• Last updated: 2019-09-23

Locations

1 site across 1 country: China