UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000026232
Receipt No. 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 2017/02/21

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email hkutsusmi@belle.shiga-med.ac.jp

Sponsor
Institute Department of Gastroenterology.
Fukushima Medical University Aizu Medical center.
Institute
Department

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
Email

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
Date of protocol fixation
2017 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 10 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
2017 Year 02 Month 20 Day
Last modified on
2017 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.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
Registered date File name


Contact us.