UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010253 |
|---|---|
| Receipt number | R000011995 |
| Scientific Title | Clinical research on ductile penetrating method with patened suture-assistance instrument |
| Date of disclosure of the study information | 2013/03/25 |
| Last modified on | 2013/03/15 12:03:41 |
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Basic information
Public title
Clinical research on ductile penetrating method with patened suture-assistance instrument
Acronym
Clinical research on DPM
Scientific Title
Clinical research on ductile penetrating method with patened suture-assistance instrument
Scientific Title:Acronym
Clinical research on DPM
Region
| Japan |
Condition
Condition
pancreatic cancer, bile duct cancer, ampulla of Vater cancer, duodenal cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to examine the safty and efficacy of the ductile penetrating method (DPM) with the patented suture-assistance instrument
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
incidence rate of Grade B and/or C pancreatic fistula in accordance with ISGPF criteria
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
to perfome a novel surgical suture technique
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
a patient who will be received pancreatoduodenectomy and reconstructed by duct-to-mucosa anastomosis between the remnant panceras and the jejunum
Key exclusion criteria
a patient who has a dilated main pancreatic duct more than 10-mm preoperatively
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomio UENO |
Organization
Yamaguchi University Hospital
Division name
Department of Surgery II
Zip code
Address
1-1-1 Minami-kogushi, Ube, Yamaguchi
TEL
+81-836-22-2264
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiko ISOZAKI |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Digestive Surgery and Surgical Oncology
Zip code
Address
1-1-1 Minami-kogushi, Ube, Yamaguchi
TEL
+81-836-22-2264
Homepage URL
Sponsor or person
Institute
Department of Digestive Surgery and Surgical Oncology, Yamaguchi UniversityGraduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Digestive Surgery and Surgical Oncology, Yamaguchi UniversityGraduate School of Medicine
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
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
| 2013 | Year | 03 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 02 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | 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
| 2013 | Year | 03 | Month | 15 | Day |
Last modified on
| 2013 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011995
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
