UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022107 |
|---|---|
| Receipt number | R000025379 |
| Scientific Title | Panenteric surveillance of post allogeneic hematopoietic stem cell transplantat patients by using colon capsule endoscopy |
| Date of disclosure of the study information | 2016/04/27 |
| Last modified on | 2018/05/16 17:39:29 |
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Basic information
Public title
Panenteric surveillance of post allogeneic hematopoietic stem cell transplantat patients by using colon capsule endoscopy
Acronym
Panenteric surveillance of post allogeneic hematopoietic stem cell transplantat patients by using colon capsule endoscopy
Scientific Title
Panenteric surveillance of post allogeneic hematopoietic stem cell transplantat patients by using colon capsule endoscopy
Scientific Title:Acronym
Panenteric surveillance of post allogeneic hematopoietic stem cell transplantat patients by using colon capsule endoscopy
Region
| Japan |
Condition
Condition
post allogenic hematopoietic stem cell transplantation
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the sensitivity of colon capsule endoscopy as compared to the conventional endoscopy and enteroscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity of colon capsule endoscopy as compared to the conventional endoscopy and histopathology.
Key secondary outcomes
Correlation between colon capsule endoscopic findings and Acute GVHD clinical grades.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Performing colon capsule endoscopy in the 21-28 day after post allogenic hematopoietic stem cell transplantation.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are scheduled for allogenic hematopoietic stem cell transplantation.
Key exclusion criteria
1.Pregnancy
2.Having medical equipment in the body(e.g. pacemaker)
3.Intestinal obstruction.
4. Suspected or known Chrohn's disease.
5.Known to invasive gastrointestinal disease associate with Blood disease.
6. Contraindication for endoscopy
7. Patients who have morphine refractory diarrhea
8. Allergy of following medicine
8-1. Mosapride
8-2. Dimethicone
8-3. PEG with ascorvic acid
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Hosoe |
Organization
Keio University Hospital
Division name
Center for Diagnostic and Therapeutic Endoscopy
Zip code
Address
35, Shinanomachi, Shinjuku, Tokyo, Japan
TEL
03-3353-1211
nhosoe@z5.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Hosoe |
Organization
Keio University Hospital
Division name
Center for Diagnostic and Therapeutic Endoscopy
Zip code
Address
35, Shinanomachi, Shinjuku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
nhosoe@z5.keio.jp
Sponsor or person
Institute
Keio University Hospital
Institute
Department
Personal name
Funding Source
Organization
Keio University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
慶應義塾大学病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2016 | Year | 01 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 27 | Day |
Last modified on
| 2018 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025379
