UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004708 |
|---|---|
| Receipt number | R000005595 |
| Scientific Title | Laparoscopic treatment of congenital biliary dilatation |
| Date of disclosure of the study information | 2011/06/13 |
| Last modified on | 2016/12/19 22:27:31 |
* 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
Laparoscopic treatment of congenital biliary dilatation
Acronym
Laparoscopic treatment of congenital biliary dilatation
Scientific Title
Laparoscopic treatment of congenital biliary dilatation
Scientific Title:Acronym
Laparoscopic treatment of congenital biliary dilatation
Region
| Japan |
Condition
Condition
Congenital biliary dilatation
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and feasibility of the laparoscopic resection of extrahepatic bile duct and bilio-entero anastomosis for congenital biliary dilatation
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complication rate
postoperative hospital stay
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Laparoscopic resection of extrahepatic bile duct, bilio-enteric anastomosis
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)Congenital biliary dilatation, Todani classification typeI or IV
2)ECOG Performance Status : 0-2
3)Major organ function is preserved and general anesthesia is possible
4)Signed informed consent
Key exclusion criteria
1)Past history of upper abdominal surgery
2)Synchronous malignancies
3)Emergency surgery
4)Acute or chronic pancreatitis
5)Acute cholangitis
6)Women during pregnancy
7)Patients judged as inadequate by investigators
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Unno Michiaki |
Organization
Tohoku University Hospital
Division name
Hepato-Biliary Pancreatic surgery
Zip code
Address
1-1 Seiryo-cho, Aoba-ku, Sendai, 980-8574, Japan
TEL
022-717-7205
m_unno@surg1.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takanori Morikawa |
Organization
Tohoku University Hospital
Division name
Hepato-Biliary Pancreatic surgery
Zip code
Address
1-1 Seiryo-cho, Aoba-ku, Sendai, 980-8574, Japan
TEL
022-717-7205
Homepage URL
t_morikawa@surg1.med.tohoku.ac.jp
Sponsor or person
Institute
Departent of Surgery, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
| 2011 | Year | 06 | Month | 13 | 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
| 2010 | Year | 09 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | 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
| 2010 | Year | 12 | Month | 12 | Day |
Last modified on
| 2016 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005595
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
