search
Back to results

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

Primary Purpose

Gastrointestinal Vascular Malformation

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
balloon assisted enteroscopy
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Vascular Malformation focused on measuring Gastrointestinal vascular malformation, Endoscopic Therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endoscopic Intervention Group

Arm Description

Endoscopic therapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
difference in Blood Transfusions Requirements
difference in Total Transfused Red Cell Requirements
difference in yearly bleeding Episodes
difference in yearly mean Hemoglobin (Hb) level
numbers of patients requiring hospitalization
difference of yearly hospitalization times
difference of the number of days in hospital yearly
difference in mean iron requirements

Full Information

First Posted
March 11, 2016
Last Updated
September 19, 2019
Sponsor
Shanghai Jiao Tong University School of Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT02716545
Brief Title
the Efficiency of Endoscopic Treatment for Recurrent Small Intestinal Bleeding Due to Gastrointestinal Vascular Malformation
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Vascular Malformation
Keywords
Gastrointestinal vascular malformation, Endoscopic Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endoscopic Intervention Group
Arm Type
Experimental
Arm Description
Endoscopic therapy
Intervention Type
Device
Intervention Name(s)
balloon assisted enteroscopy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Participants Whose yearly Rebleeding times Decreased From Baseline by ≥ 50%
Time Frame
up to 3 yrs
Secondary Outcome Measure Information:
Title
Difference of patients completely cured
Description
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
Title
difference in Blood Transfusions Requirements
Time Frame
up to 3 yrs
Title
difference in Total Transfused Red Cell Requirements
Time Frame
up to 3 yrs
Title
difference in yearly bleeding Episodes
Time Frame
up to 3 yrs
Title
difference in yearly mean Hemoglobin (Hb) level
Time Frame
up to 3 yrs
Title
numbers of patients requiring hospitalization
Time Frame
up to 3 yrs
Title
difference of yearly hospitalization times
Time Frame
up to 3 yrs
Title
difference of the number of days in hospital yearly
Time Frame
up to 3 yrs
Title
difference in mean iron requirements
Time Frame
up to 3 yrs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhizheng Ge, MD, Ph D
Email
zhizhengge@aliyun.com
Facility Information:
Facility Name
Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhizheng Ge, MD. Ph.D
Phone
18621890923
Email
zhizhengge@aliyun.com.cn
First Name & Middle Initial & Last Name & Degree
Zhizheng Ge, MD. Ph.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs