UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027169 |
|---|---|
| Receipt number | 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 | 2020/10/29 14:43:00 |
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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 | Shunichiro |
| Middle name | |
| Last name | Komatsu |
Organization
Aichi Medical University
Division name
Gastroenterological Surgery
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Aichi Pref.
TEL
0561-62-3311
skomat@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Shunichiro |
| Middle name | |
| Last name | Komatsu |
Organization
Aichi Medical University
Division name
Gastroenterological Surgery
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Aichi Pref.
TEL
0561-62-3311
Homepage URL
skomat@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
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
Institutional review board of Aichi Medical University Hospital
Address
1-1 Yazakokarimata, Nagakute, Aichi 480-1195, Japan
Tel
0561-62-3311
amu_ethics@aichi-med-u.ac.jp
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
Published
Result
URL related to results and publications
http://link.springer.com/article/10.1007/s00464-020-07779-y
Number of participants that the trial has enrolled
38
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
Main results already published
Date of protocol fixation
| 2017 | Year | 04 | Month | 19 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 19 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | 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
| 2017 | Year | 04 | Month | 27 | Day |
Last modified on
| 2020 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.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 |
