UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026232 |
|---|---|
| Receipt number | R000030127 |
| Scientific Title | Comparative study of the conventional catheter and the new device for cannulation in difficult ERCP case: a multicentre, crossover, randomised controlled trial. |
| Date of disclosure of the study information | 2017/02/21 |
| Last modified on | 2022/03/09 12:35:24 |
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Basic information
Public title
Comparative study of the conventional catheter and the new device for cannulation in difficult ERCP case: a multicentre, crossover, randomised controlled trial.
Acronym
The evaluation of the new device for cannulation for difficult case on ERCP.
Scientific Title
Comparative study of the conventional catheter and the new device for cannulation in difficult ERCP case: a multicentre, crossover, randomised controlled trial.
Scientific Title:Acronym
The evaluation of the new device for cannulation for difficult case on ERCP.
Region
| Japan |
Condition
Condition
pancreatobliary disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the new cannulation device for difficult case of deep biliary cannulation on ERCP.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
success rate of deep biliary cannulation
Key secondary outcomes
1. time for success
2. kind of used guide wire
3. kind of used catheter
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Objective patient is selected group A (conventional method) or group B (new device). Operator perform ERCP according to the selection.
Interventions/Control_2
In each group, ERCP catheter will be changed if it is difficult to insert deeply into the bile duct for 6 minutes.
If successful cannulation is not obtained, various techniques are used for deep cannulation into the bile duct.
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) the patient who is necessary to perform ERCP, especially insertion into the bile duct.
2) The patient that a document agreement by the free will of a patient was provided after enough understanding after having received enough explanation about inspection.
3) age more than 20 y/o
Key exclusion criteria
1) Performance Status (PS)4
2) Patient having previous treatment for ampulla.
3) Status after gastrectomy
4) Having the serious complications in other organs
5) There is no informed consent.
6) Subjects judged as inappropriate candidates for the trial by the investigators.
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Irisawa |
Organization
Fukushima Medical University Aizu Medical Center
Division name
Department of Gastroenterology
Zip code
Address
21-2, Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu, 969-3492
TEL
0242-75-2100
irisawa@fmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromu Kutsumi |
Organization
Shiga University of Medical Science Hospital
Division name
Center for clinical research and development
Zip code
Address
Tsukinowa, Seda, Otsu, Shiga
TEL
077-548-3665
Homepage URL
hkutsusmi@belle.shiga-med.ac.jp
Sponsor or person
Institute
Department of Gastroenterology.
Fukushima Medical University Aizu Medical center.
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University Aizu Medical Center
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
| 2017 | Year | 02 | Month | 21 | 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
| 2017 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 20 | Day |
Last modified on
| 2022 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030127
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
