UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009684 |
|---|---|
| Receipt number | R000011358 |
| Scientific Title | Usefulness of precutting for patinets with difficult biliary cannulation: A randomized trial; Needle knife precut over the pancreatic stent with small incision vs pancreatic sphincterotomy |
| Date of disclosure of the study information | 2013/01/03 |
| Last modified on | 2013/01/03 21:41:20 |
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Basic information
Public title
Usefulness of precutting for patinets with difficult biliary cannulation: A randomized trial; Needle knife precut over the pancreatic stent with small incision vs pancreatic sphincterotomy
Acronym
Usefulness of precutting for patinets with difficult biliary cannulation: A randomized trial; Needle knife precut over the pancreatic stent with small incision vs pancreatic sphincterotomy
Scientific Title
Usefulness of precutting for patinets with difficult biliary cannulation: A randomized trial; Needle knife precut over the pancreatic stent with small incision vs pancreatic sphincterotomy
Scientific Title:Acronym
Usefulness of precutting for patinets with difficult biliary cannulation: A randomized trial; Needle knife precut over the pancreatic stent with small incision vs pancreatic sphincterotomy
Region
| Japan |
Condition
Condition
biliary stenosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A randomized trial compared two groups;
group with NKOP-SIPS vs PS.
Evaluation of success and complications rates
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
success and complication rates
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
method of precutting
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patinets with difficult biliary cannulation ( more than 15 minutes even if expert hands failed).
Successfully guidewire placement for pancreatic duct.
Key exclusion criteria
*Patients being candidate not therapeutic ERCP
*Patinets who showed coagulopathy.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | kensuke kubota |
Organization
Yokohama City University Hospital
Division name
Endoscopy
Zip code
Address
Fukuura3-9, Yokohama
TEL
045-787-2800
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | kensuke kubota |
Organization
Yokohama City University Hospital
Division name
Endoscopy
Zip code
Address
Fukuura3-9, Yokohama
TEL
045-788-2800
Homepage URL
kubotak@yokohama-cu.ac.jp
Sponsor or person
Institute
Fukuura3-9, Yokohama
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Hospital
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
横浜市立大学付属病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 03 | 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
| 2013 | Year | 01 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 03 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 03 | Day |
Last modified on
| 2013 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011358
