UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041904 |
|---|---|
| Receipt number | R000047831 |
| Scientific Title | A Multicenter Prospective Study on the Efficacy of Small Intestinal Capsule Endoscopy in Hemodialysis Patients |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2024/09/30 19:00:27 |
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Basic information
Public title
A Multicenter Prospective Study on the Efficacy of Small Intestinal Capsule Endoscopy in Hemodialysis Patients
Acronym
PROCEED study
Scientific Title
A Multicenter Prospective Study on the Efficacy of Small Intestinal Capsule Endoscopy in Hemodialysis Patients
Scientific Title:Acronym
PROCEED study
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the correlation between gastrointestinal lesions and unexplained gastrointestinal bleeding on hemodialysis (Obscure GI Bleeding) or anemia of unknown origin, and to evaluate the usefulness of small intestinal capsule endoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic yield of small intestinal capsule endoscopy for hemodialysis patients
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 on maintenance dialysis who are clinically determined to undergo small bowel capsule endoscopy and have known or suspected small bowel disease due to unexplained gastrointestinal bleeding or unexplained anemia.
Key exclusion criteria
Contraindication for small bowel capsule endoscopy.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Haruhiko |
| Middle name | |
| Last name | Ogata |
Organization
Keio university school of medicine
Division name
Center for diagnostic therapeutic endoscopy
Zip code
160-8582
Address
Shinjuku-ku Shinanomachi 35
TEL
0333531211
nhosoe@keio.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Hosoe |
Organization
Keio university school of medicine
Division name
Center for diagnostic therapeutic endoscopy
Zip code
160-8582
Address
Shinjuku-ku Shinanomachi 35
TEL
0333531211
Homepage URL
nhosoe@keio.jp
Sponsor or person
Institute
Keio university school of medicine
Institute
Department
Personal name
Funding Source
Organization
Covidien co Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
The Japanese association for capsule endoscopy
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics commiteKeio University
Address
Shinjuku-ku Shinanomachi 35
Tel
0333531211
med-rinri-jimu@adst.keio.ac.jp
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
日本カプセル内視鏡学会会員施設
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
not yet officially announced
Publication of results
Unpublished
Result
URL related to results and publications
The 17th Annual Meeting of the Japanese Society for Capsule Endoscopy
Number of participants that the trial has enrolled
20
Results
The mean age was 71.4 years, male to female ratio was 14:6, and the mean duration of dialysis was 11.4 years. The reasons for examination were OGIB in 10 cases (6 Overt, 4 Occult), anemia scrutiny in 8 cases, and others in 2 cases. The lesions detected by capsule endoscopy were described by the Saurin et al. classification: no abnormality or P0 in 4 cases, P1: possible source of bleeding unknown in 12 cases, and P2: probable source of bleeding in 4 cases.
Results date posted
| 2024 | Year | 09 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Chronic dialysis patient undergoing capsule endoscopy
Participant flow
Register the above patients
Adverse events
no adverse event.
Outcome measures
Efficacy of capsule endoscopy
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2019 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The Japanese association for capsule endoscopy
Management information
Registered date
| 2020 | Year | 09 | Month | 27 | Day |
Last modified on
| 2024 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047831
