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

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.

Study Overview

• Status: Unknown
• Conditions: Gastrointestinal Vascular Malformation
• Intervention / Treatment: Device: balloon assisted enteroscopy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhizheng Ge, MD, Ph D; Email: zhizhengge@aliyun.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Recruiting
      • Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine
      • Contact: Zhizheng Ge, MD. Ph.D; Phone Number: 18621890923; Email: zhizhengge@aliyun.com.cn
      • Principal Investigator: Zhizheng Ge, MD. Ph.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Endoscopic Intervention Group; Endoscopic therapy

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Participants Whose yearly Rebleeding times Decreased From Baseline by ≥ 50%	up to 3 yrs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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
numbers of patients requiring hospitalization		up to 3 yrs
difference of yearly hospitalization times		up to 3 yrs
difference of the number of days in hospital yearly		up to 3 yrs
difference in mean iron requirements		up to 3 yrs

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: March 11, 2016
• First Submitted That Met QC Criteria: March 22, 2016
• First Posted (Estimate): March 23, 2016

Study Record Updates

• Last Update Posted (Actual): September 23, 2019
• Last Update Submitted That Met QC Criteria: September 19, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Gastrointestinal vascular malformation; Endoscopic Therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Cardiovascular Abnormalities; Congenital Abnormalities; Vascular Malformations
• Other Study ID Numbers: rj(2015)088K-b

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO