UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038326 |
|---|---|
| Receipt number | 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 09:03:03 |
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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
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
yoshi-hk@openhp.or.jp
Sponsor or person
Institute
Sendai City Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043680
