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

NCT ID: NCT02716545

Last Updated: 2019-09-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2020-12-31

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.

Conditions

Gastrointestinal Vascular Malformation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endoscopic Intervention Group

Endoscopic therapy

Group Type: EXPERIMENTAL

balloon assisted enteroscopy

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Zhizheng Ge

Director of digestive endoscopy centre of Renji hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhizheng Ge, MD, Ph D

Role: CONTACT

zhizhengge@aliyun.com

Facility Contacts

Zhizheng Ge, MD. Ph.D

Role: primary

zhizhengge@aliyun.com.cn

18621890923

Other Identifiers

rj(2015)088K-b

Identifier Type: -

Identifier Source: org_study_id