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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033326
Receipt No. 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

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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
Email 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
Email ryoji0331@yahoo.co.jp

Sponsor
Institute National Cancer Center Hospital Japan
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036411

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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