UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050990 |
|---|---|
| Receipt number | R000058125 |
| Scientific Title | Efficacy of a novel technique of choledochojejunostomy, "T-shaped anastomosis," in pancreatoduodenectomy for preventing the development of postoperative cholangitis |
| Date of disclosure of the study information | 2023/05/04 |
| Last modified on | 2023/05/04 22:22:22 |
* 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
Efficacy of a novel technique of choledochojejunostomy, "T-shaped anastomosis," in pancreatoduodenectomy for preventing the development of postoperative cholangitis
Acronym
Novel technique of choledochojejunostomy, "T-shaped anastomosis," in PD
Scientific Title
Efficacy of a novel technique of choledochojejunostomy, "T-shaped anastomosis," in pancreatoduodenectomy for preventing the development of postoperative cholangitis
Scientific Title:Acronym
Novel technique of choledochojejunostomy, "T-shaped anastomosis," in PD
Region
| Japan |
Condition
Condition
Pancreatoduodenectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the efficacy of a novel choledochojejunostomy with a larger anastomotic diameter, "T-shaped anastomosis," in preventing the development of postoperative cholangitis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of medium-term postoperative cholangitis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
T-shaped choledochojejunostomy
Interventions/Control_2
standard choledochojejunostomy
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
pancreatoduodenectomy
Key exclusion criteria
1. hilar recurrence
2. postoperative complications of Clavien-Dindo Grade IVb or higher
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Fujii |
Organization
University of Toyama
Division name
Department of Surgery and Science
Zip code
9300194
Address
2630, Sugitani, Toyama, Toyama
TEL
0764347331
fjt@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Tsutomu |
| Middle name | |
| Last name | Fujii |
Organization
University of Toyama
Division name
Department of Surgery and Science
Zip code
9300194
Address
2630, Sugitani, Toyama, Toyama
TEL
0764347331
Homepage URL
fjt@med.u-toyama.ac.jp
Sponsor or person
Institute
Ministry of Education, Culture, Sports, Science and Technology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center for Clinical Research, Toyama University Hospital
Address
2630, Sugitani, Toyama, Toyama
Tel
076-434-2281
rinri@adm.u-toyama.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
| 2023 | Year | 05 | Month | 04 | 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
250
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 04 | Day |
Last modified on
| 2023 | Year | 05 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058125
