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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027169
Receipt No. R000031101
Scientific Title Prospective study evaluating the efficacy of a super-thin choledochoscope in the laparoscopic transcystic common bile duct exploration
Date of disclosure of the study information 2017/05/01
Last modified on 2017/05/09

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Basic information
Public title Prospective study evaluating the efficacy of a super-thin choledochoscope in the laparoscopic transcystic common bile duct exploration
Acronym Efficacy of a super-thin choledochoscope in laparoscopic common bile duct exploration
Scientific Title Prospective study evaluating the efficacy of a super-thin choledochoscope in the laparoscopic transcystic common bile duct exploration
Scientific Title:Acronym Efficacy of a super-thin choledochoscope in laparoscopic common bile duct exploration
Region
Japan

Condition
Condition Patients who are diagnosed, or suspected, as harboring common bile duct (CBD) stones and scheduled to undergo elective laparoscopic cholecystectomy
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objectives of this study are as follows:
#1 To evaluate the feasibility of passing a super-thin choledochoscope into the CBD using a transcystic technique and establishing the area the scope can visualize.
#2 To compare the choledocholithiasis diagnostic accuracy using a super-thin choledochoscope with that of magnetic resonance cholangiopancreatography (MRCP) and intraoperative cholangiography (IOC).
#3 To confirm the safety and resuced invasiveness of the procedure.
The goal of our study is to assess the efficacy of transcystic CBD exploration, using a super-thin choledochoscope, for pre- and intra-operative diagnosis and in one-stage laparoscopic management of CBD stones
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary outcomes are successful insertion of the super-thin choledochoscope into the common bile duct (CBD) via transcystic route and successful CBD exploration of both the distal (to the papilla) and proximal (to the bifurcation) parts of the bile duct.
Key secondary outcomes To evaluate whether the choledochoscope contributes to improvement in the detection and one-stage clearance of CBD stones

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Laparoscopic transcystic common bile duct exploration using a super-thin choledochoscope
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1 Patients diagnosed with CBD stones, confirmed or suspected as a result of clinical symptoms, serological tests, ultrasonography or MRCP, who are scheduled to undergo elective laparoscopic cholecystectomy (regardless of whether they underwent endoscopic sphincterotomy)
2 Patients older than 19 years of age at the time of surgery
3 Patients providing written informed consent
Key exclusion criteria 1 Large(9mm or more) or multiple (n=6 or more)CBD stones
2 Suspected primary CBD stones
3 Intrahepatic stones or biliary dilatation
4 Aberrant hepatic duct which joins the cystic duct or the bile duct close to the cystic duct
5 Anomalous arrangement of the pancreaticobiliary ducts
6 Suspected biliary malignancy
7 Allergic to radiopaque contrasts
8 Short cystic duct making the introduction of choledochoscope problematic
9 Acute cholecystitis
10 Presence of a biliary stent at the time of surgery
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shunichiro Komatsu
Organization Aichi Medical University
Division name Gastroenterological Surgery
Zip code
Address 1-1 Yazakokarimata, Nagakute, Aichi Pref.
TEL 0561-62-3311
Email skomat@aichi-med-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shunichiro Komatsu
Organization Aichi Medical University
Division name Gastroenterological Surgery
Zip code
Address 1-1 Yazakokarimata, Nagakute, Aichi Pref.
TEL 0561-62-3311
Homepage URL
Email skomat@aichi-med-u.ac.jp

Sponsor
Institute Aichi Medical University
Institute
Department

Funding Source
Organization Aichi Medical University
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 05 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 Open public recruiting
Date of protocol fixation
2017 Year 04 Month 19 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 01 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 04 Month 27 Day
Last modified on
2017 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031101

Research Plan
Registered date File name
2017/05/09 研究計画書(治療計画書)11.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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