Gastrointestinal Vascular MalformationNCT02716545
the Efficiency of Endoscopic Treatment for Recurrent Small Intestinal Bleeding Due to Gastrointestinal Vascular Malformation
A study testing balloon assisted enteroscopy in people with Gastrointestinal Vascular Malformation, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastrointestinal Vascular Malformation
- What is being tested?
- balloon assisted enteroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Zhizheng Ge, MD, Ph D contact
China1 site, 1 recruiting
- Recruiting
Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Zhizheng Ge, MD. Ph.D, 18621890923, zhizhengge@aliyun.com.cn
Zhizheng Ge, MD. Ph.
About this study
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
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.
Read the 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
- Being tested
- balloon assisted enteroscopy
- Keywords
- Gastrointestinal vascular malformation, Endoscopic Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balloon assisted enteroscopyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Intervention Group | Experimental | Endoscopic therapy Receives: Device: balloon assisted enteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants Whose yearly Rebleeding times Decreased From Baseline by ≥ 50%
Measured: up to 3 yrs
Secondary outcomes (9)
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
Measured: up to 3 yrs
difference in Blood Transfusions Requirements
Measured: up to 3 yrs
difference in Total Transfused Red Cell Requirements
Measured: up to 3 yrs
difference in yearly bleeding Episodes
Measured: up to 3 yrs
difference in yearly mean Hemoglobin (Hb) level
Measured: up to 3 yrs
numbers of patients requiring hospitalization
Measured: up to 3 yrs
difference of yearly hospitalization times
Measured: up to 3 yrs
difference of the number of days in hospital yearly
Measured: up to 3 yrs
difference in mean iron requirements
Measured: up to 3 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Vascular MalformationStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhizheng Ge, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02716545
- Sponsor's protocol ID
- rj(2015)088K-b
- Status last verified
- Sep 2019
- First submitted
- 11 Mar 2016
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02716545
- Acronym / sponsor ID
- rj(2015)088K-b
- Conditions
- Gastrointestinal Vascular Malformation
- Keywords
- Gastrointestinal vascular malformation, Endoscopic Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 23 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Intervention Group | Experimental | Device: balloon assisted enteroscopyEndoscopic therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| balloon assisted enteroscopyPatients 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. | Device | Endoscopic Intervention Group |
Primary outcome
Participants Whose yearly Rebleeding times Decreased From Baseline by ≥ 50%
Time frame: up to 3 yrs
9 secondary outcomes
Difference of patients completely cured
Time frame: up to 3 yrs
difference in Blood Transfusions Requirements
Time frame: up to 3 yrs
difference in Total Transfused Red Cell Requirements
Time frame: up to 3 yrs
difference in yearly bleeding Episodes
Time frame: up to 3 yrs
difference in yearly mean Hemoglobin (Hb) level
Time frame: up to 3 yrs
numbers of patients requiring hospitalization
Time frame: up to 3 yrs
difference of yearly hospitalization times
Time frame: up to 3 yrs
difference of the number of days in hospital yearly
Time frame: up to 3 yrs
difference in mean iron requirements
Time frame: up to 3 yrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Individual participant dataSharing planned: No
Related trials for Gastrointestinal Vascular Malformation
RecruitingPhase 2
Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015)
Pheochromocytoma/Paraganglioma, Pancreatic Neuroendocrine Tumor
RecruitingObservational study
Natural History and Genetics of Food Allergy and Related Conditions
Food Allergy, Loeys-Dietz Syndrome
Not yet recruitingObservational study
Vascular Health and Function in Cystic Fibrosis
Cystic Fibrosis, Endothelial Dysfunction
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhizheng Ge, MD, Ph D contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing balloon assisted enteroscopy in people with Gastrointestinal Vascular Malformation, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhizheng Ge, MD, Ph D (zhizhengge@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants Whose yearly Rebleeding times Decreased From Baseline by ≥ 50% (time frame: up to 3 yrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.