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

NCT02716545 | Unknown DMC

• 1 other identifier: rj(2015)088K-b
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Vascular Malformation

Keywords

Gastrointestinal vascular malformation; Endoscopic Therapy

Outcome Measures

Primary Outcomes (1)

• Participants Whose yearly Rebleeding times Decreased From Baseline by ≥ 50%

  up to 3 yrs

Secondary Outcomes (9)

• Difference of patients completely cured

  up to 3 yrs

• difference in Blood Transfusions Requirements

  up to 3 yrs

• difference in Total Transfused Red Cell Requirements

  up to 3 yrs

• difference in yearly bleeding Episodes

  up to 3 yrs

• difference in yearly mean Hemoglobin (Hb) level

  up to 3 yrs

Study Arms (1)

Endoscopic Intervention Group

EXPERIMENTAL

Endoscopic therapy

Device: balloon assisted enteroscopy

Interventions

balloon assisted enteroscopy 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.

Endoscopic Intervention Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Central Study Contacts

Zhizheng Ge, MD, Ph D

CONTACT

zhizhengge@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of digestive endoscopy centre of Renji hospital

Study Record Dates

• First Submitted: March 11, 2016
• First Posted: March 23, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: September 23, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)