UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000033326 |
|---|---|
| Receipt number | R000036411 |
| Scientific Title | Efficacy of full-spectrum endoscopy (FUSE) to visualize the ampulla of Vater in patients with familial adenomatous polyposis (FAP) |
| Date of disclosure of the study information | 2018/07/09 |
| Last modified on | 2018/11/04 10:18:11 |
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Basic information
Public title
Efficacy of full-spectrum endoscopy (FUSE) to visualize the ampulla of Vater in patients with familial adenomatous polyposis (FAP)
Acronym
FUSE to visualize the ampulla of Vater in patients with FAP
Scientific Title
Efficacy of full-spectrum endoscopy (FUSE) to visualize the ampulla of Vater in patients with familial adenomatous polyposis (FAP)
Scientific Title:Acronym
FUSE to visualize the ampulla of Vater in patients with FAP
Region
| Japan |
Condition
Condition
familial adenomatous polyposis (FAP):
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Duodenal cancer is one of the extracolonic malignancies which cause death in patients with Familial adenomatous polyposis (FAP). However, the visualization of the ampulla of Vater is not always sufficient with a standard esophagogastroduodenoscopy (EGD) because of limited field of view. Full-spectrum endoscopy (FUSE) provides wide field of view up to 245-degree with double imagers on the front and left side of endoscope tip. The aim of this prospective study was to evaluate the improvement of visualization of the ampulla of Vater in FAP
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of visibility of whole area of the papilla off-line review
Key secondary outcomes
The proportion of visibility of whole area ofthe papilla on-site diagnosis
detection of major duodenal papilla neoplasm and their visibility
adverse event
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
inclusion criteria is familial adenomatous polyposis followed up in our hospital
Key exclusion criteria
past history of upper gastrointestinal surgery
and papillectomy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Abe Seiichiro |
Organization
National Cancer Center Hospital Japan
Division name
Endoscopy Division
Zip code
Address
5-1-1, Tsukiji, Chuoku, Tokyo
TEL
03-3542-2511
seabe@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryoji Ichijima |
Organization
National Cancer Center Hospital Japan
Division name
Endoscopy Division
Zip code
Address
5-1-1, Tsukiji, Chuoku, Tokyo
TEL
03-3542-2511
Homepage URL
ryoji0331@yahoo.co.jp
Sponsor or person
Institute
National Cancer Center Hospital Japan
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Hospital Japan
Organization
Division
Category of Funding Organization
Other
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
| 2018 | Year | 07 | Month | 09 | 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
| 2016 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
EGD will performed using FUSE by qualified endoscopists of the Japanese Gastroenterological Endoscopy Society and visibility of the ampulla of Vater will be evaluated. All examinations will video-recorded and two videos of duodenum observation (forward-viewing and left side viewing (FUSE group) and forward viewing alone (conventional group) were edited in each patients. Three another qualified endoscopists at outside institution reviewed the videos and compared the visibility of the ampulla of Vater between the FUSE and the conventional group.
Management information
Registered date
| 2018 | Year | 07 | Month | 08 | Day |
Last modified on
| 2018 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036411
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
