UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008445 |
|---|---|
| Receipt number | R000009934 |
| Scientific Title | A prospective randomized controlled trial of wire guided deep biluary cannulation using straight and angled tip guidewire. |
| Date of disclosure of the study information | 2012/07/20 |
| Last modified on | 2014/01/16 09:07:46 |
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Basic information
Public title
A prospective randomized controlled trial of wire guided deep biluary cannulation using straight and angled tip guidewire.
Acronym
A prospective randomized controlled trial of WGC using using straight and angled guidewire.
Scientific Title
A prospective randomized controlled trial of wire guided deep biluary cannulation using straight and angled tip guidewire.
Scientific Title:Acronym
A prospective randomized controlled trial of WGC using using straight and angled guidewire.
Region
| Japan |
Condition
Condition
Biliary diseases
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparsion of deep cannulation rete between using straight and angled tip guidewire.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success rate of biliary deep cannulation
Key secondary outcomes
Complicaion rate
Total proceedure time of ERCP
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Biliary cannulation using straight tip guidewire
Interventions/Control_2
Biliary cannulation using angled tip guidewire
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
1. Diagnostic or therapeutic ERCP for biliary disease
2. Naiive papilla
3. Patients who understand and are willing to give a written informed consent about participation
Key exclusion criteria
1. Patients with severely impaired hematological, hepatic, renal, and heart function.
2. Patients with performance status Patients with bleeding tendency (Plt < 50000, PT INR >= 1.5).
3. Patients with consciousness disorder (>=Japan Coma Scale I-1).
4. Patients with pancreatic disorder which need ERP.
5. Patients with tumor of amppulla of the Vater.
6. patients with surgically-altered anatomy of upper gastro intestinal tract excluding Billroth I method.
7. Patients considered ineligible for this study.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Hayashi |
Organization
Sapporo Medical University
Division name
Fourth Department of Internal Medicine
Zip code
Address
South-1, West-16, Chuo-ku Sapporo, Hokkaido, 060-8556, Japan.
TEL
011-611-2111
thayashi69@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Hayashi |
Organization
Sapporo Medical University
Division name
Fourth Department of Internal Medicine
Zip code
Address
South-1, West-16, Chuo-ku Sapporo, Hokkaido, 060-8556, Japan.
TEL
011-611-2111
Homepage URL
thayashi69@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University, Fourth Department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University, Fourth Department of Internal Medicine
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
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
| 2012 | Year | 07 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 16 | Day |
Last modified on
| 2014 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009934
