UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014646 |
|---|---|
| Receipt number | R000017042 |
| Scientific Title | Capsule Endoscopic scoring of small bowel mucosal damage after conformal radiotherapy for pancreas cancer: prospective cohort study |
| Date of disclosure of the study information | 2014/07/28 |
| Last modified on | 2015/01/25 21:28:40 |
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Basic information
Public title
Capsule Endoscopic scoring of small bowel mucosal damage after conformal radiotherapy for pancreas cancer: prospective cohort study
Acronym
CE scoring of small bowel mucosal damage after RT for PK
Scientific Title
Capsule Endoscopic scoring of small bowel mucosal damage after conformal radiotherapy for pancreas cancer: prospective cohort study
Scientific Title:Acronym
CE scoring of small bowel mucosal damage after RT for PK
Region
| Japan |
Condition
Condition
pancreas cancer
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Capsule Endoscopic scoring of small bowel mucosal damage of early stage after conformal radiotherapy for pancreas cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence rate of small bowel mucosal damage
Key secondary outcomes
Base
Study type
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Undergo Capsule Endoscopy for small bowel after conformal radiotherapy for pancreas cancer
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
The patients who is going to undergo conformal radiotherapy for pancreas cancer
Key exclusion criteria
1. History of inflammatory bowel disease
2. Ppatients with dysphagia.
3. Patients who have history of the ileus or stricture or fistula of the intestine.
4. Patients judged as inappropriate candidates for the trial by the investigators
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyasu Iishi |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Gastrointestinal
Zip code
Address
3-3, Nakamichi 1-chome, Higashinari-ku, Osaka 537-8511, Japan.
TEL
06-6972-1181
yamasina-ta@mc.pref.osak.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Yamashina |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Gastrointestinal
Zip code
Address
3-3, Nakamichi 1-chome, Higashinari-ku, Osaka 537-8511, Japan.
TEL
06-6972-1181
Homepage URL
yamasina-ta@ms.pref.osaka.jp
Sponsor or person
Institute
Department of Gastrointestinal, Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department
Personal name
Funding Source
Organization
none
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 28 | 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
Completed
Date of protocol fixation
| 2014 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 25 | Day |
Last modified on
| 2015 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017042
