UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018032 |
|---|---|
| Receipt number | R000020629 |
| Scientific Title | Initial use of Rotatable sphincterotome facilitates selective bile duct cannulation compared with use of conventional sphincterotome: a prospective randomized controlled trial of papillotome. |
| Date of disclosure of the study information | 2015/08/01 |
| Last modified on | 2018/12/24 00:57:19 |
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Basic information
Public title
Initial use of Rotatable sphincterotome facilitates selective bile duct cannulation compared with use of conventional sphincterotome: a prospective randomized controlled trial of papillotome.
Acronym
Cannulation Study
Scientific Title
Initial use of Rotatable sphincterotome facilitates selective bile duct cannulation compared with use of conventional sphincterotome: a prospective randomized controlled trial of papillotome.
Scientific Title:Acronym
Cannulation Study
Region
| Japan |
Condition
Condition
Of all diseases needed to perform ERC.
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Initial use of rotatable sphincterotome facilitate common bile duct cannulation and reduce risk of post ERCP pancreatitis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
The primary endpoint is successful selective bile duct cannulation within 10 miniutes and 10 times after randomization.
Key secondary outcomes
The secondary endpoints are successful final selective bile duct cannulation rates, procedure success rate, selective bile duct cannulation time, number of attempts at bile duct cannulation, number of accidental pancreatic duct insertions, procedure time, radiation exposure time, use of precutting for selective bile duct cannulation, and complications including PEP rates in the randomized patients and also in the initially enrolled cohort.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Rotatable shincterotome
Interventions/Control_2
Conventional sphincterotome
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. In patients with native papilla.
Key exclusion criteria
1. In patients with ECOG Perfoemance Status Grade 4.
2. In patients with impaired consciousness.
3. In patients with suspected pancreatobiliary maljunction.
4. In patients with previous gastrectomy with Billroth II or Roux-en-Y reconstruction.
5. In patients with acute pancreatitis
6. In patients with impacted stone or tumor of ampulla of Vater.
7. In patients with bilioduodenal fistula opening around the papilla
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Kurita |
Organization
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Division name
Division of Gastroenterology and Hepatology, Digestive Disease Center
Zip code
Address
2-4-20 Ohgimachi, Kita-ku, Osaka 530-8480, Japan
TEL
06-6312-8831
kuritaaki1976@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Kurita |
Organization
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Division name
Division of Gastroenterology and Hepatology, Digestive Disease Center
Zip code
Address
2-4-20 Ohgimachi, Kita-ku, Osaka 530-8480, Japan
TEL
06-6312-8831
Homepage URL
kuritaaki1976@gmail.com
Sponsor or person
Institute
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
田附興風会医学研究所北野病院(大阪府)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 01 | 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
| 2015 | Year | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 20 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 20 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 22 | Day |
Last modified on
| 2018 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020629
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
