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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038326
Receipt No. R000043680
Scientific Title Prospective study on the predictive value of the stopped-folds sign for detection of the afferent loop into which the enteroscope is inserted for endoscopic retrograde cholangiopancreatography in cases with Roux-en-Y reconstruction
Date of disclosure of the study information 2019/10/18
Last modified on 2019/10/18

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Basic information
Public title Prospective study on the predictive value of the stopped-folds sign for detection of the afferent loop into which the enteroscope is inserted for endoscopic retrograde cholangiopancreatography in cases with Roux-en-Y reconstruction
Acronym Stopped fold study
Scientific Title Prospective study on the predictive value of the stopped-folds sign for detection of the afferent loop into which the enteroscope is inserted for endoscopic retrograde cholangiopancreatography in cases with Roux-en-Y reconstruction
Scientific Title:Acronym Stopped fold study
Region
Japan

Condition
Condition Pancreatobiliary diseases requiring ERCP
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Balloon-assisted enteroscopy has enabled endoscopic retrograde cholangiopancreatography (ERCP) in patients with surgically altered anatomy. However, in Roux-en-Y (RY) cases, it is difficult to judge the correct way at the junction of RY anastomosis.
The stopped-fold sign (SFS), which indicates the correct way at the junction, is helpful. We planned a prospective evaluation of the sign.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The rate of successful identification of the afferent loop using the SFS
Key secondary outcomes Procedure time, procedural success rate, adverse events related to the procedure

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
1 years-old <=
Age-upper limit
120 years-old >
Gender Male and Female
Key inclusion criteria a. RY reconstruction
b. Necessity of ERCP
c. Written informed consent
Key exclusion criteria a. Impossibility to undergo endoscopic treatment
b. Poor general condition, ASA 4 or more
c. Previous registration to this study
d. Previous marking that indicates the afferent loop
e. Reconstruction except RY
f. Being inappropriate for ERCP
g. Rendez-vous guidance
h. Doctor's discretion to be inappropriate
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Yoshihide
Middle name
Last name Kanno
Organization Sendai City Medical Center
Division name Department of Gastroenterology
Zip code 983-0824
Address Tsurugaya 5-22-1, Miyagino-ku, Sendai, Miyagi, Japan
TEL 022-252-1111
Email yoshi-hk@openhp.or.jp

Public contact
Name of contact person
1st name Yoshihide
Middle name Kanno
Last name Kanno
Organization Sendai City Medical Center
Division name Department of Gastroenterology
Zip code 983-0824
Address Tsurugaya 5-22-1, Miyagino-ku, Sendai, Miyagi, Japan
TEL 022-252-1111
Homepage URL
Email yoshi-hk@openhp.or.jp

Sponsor
Institute Sendai City Medical Center
Institute
Department

Funding Source
Organization Self-funding
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 Institutional Review Board of Sendai City Medical Center
Address Tsurugaya 5-22-1, Miyagino-ku, Sendai, Miyagi, Japan
Tel 022-252-1111
Email yoshihk44@yahoo.co.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

Other administrative information
Date of disclosure of the study information
2019 Year 10 Month 18 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 Open public recruiting
Date of protocol fixation
2019 Year 04 Month 19 Day
Date of IRB
2019 Year 04 Month 19 Day
Anticipated trial start date
2019 Year 04 Month 20 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 study outcomes shall rapidly be published after analysis of the data.

Management information
Registered date
2019 Year 10 Month 18 Day
Last modified on
2019 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043680

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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