UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012241 |
|---|---|
| Receipt number | R000014311 |
| Scientific Title | Randomized Phase II trial of right half dissection of superior mesenteric artery nerve plexus in pancreatoduodenectomy for pancreatic head cancer |
| Date of disclosure of the study information | 2013/11/08 |
| Last modified on | 2022/11/15 10:02:16 |
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Basic information
Public title
Randomized Phase II trial of right half dissection of superior mesenteric artery nerve plexus in pancreatoduodenectomy for pancreatic head cancer
Acronym
Randomized Phase II trial of right half dissection of superior mesenteric artery nerve plexus
Scientific Title
Randomized Phase II trial of right half dissection of superior mesenteric artery nerve plexus in pancreatoduodenectomy for pancreatic head cancer
Scientific Title:Acronym
Randomized Phase II trial of right half dissection of superior mesenteric artery nerve plexus
Region
| Japan |
Condition
Condition
Pancreatic head cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the implication of right half dissection of superior mesenteric artery nerve plexus in surgery for pancreatic head cancer
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
rate of local recurrence
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
right half dissection of superior mesenteric artery nerve plexus
Interventions/Control_2
preservation of superior mesenteric artery nerve plexus
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)will undergo pancreatoduodenectomy for resectable pancreatic head cancer
(2)no invasion of SMA nerve plexus, R0 operation
(3)20 y.o-75y.o
(4)written informed consent
Key exclusion criteria
(1)other malignant pancreatic tumor
(2)invasion of SMA
(3)active infection
(4)pulmonary disease
(5)chronic renal failure
(6)active double cancer
(7)uncontrolled watery diarrhea
(8)possibly pregnant females
(9)no consent
(10)inappropriate cases
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Kodera |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
4668550
Address
65,Tsurumai-cho,Showa-ku,Nagoya,Aichi
TEL
052-744-2245
fjt@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Tsutomu |
| Middle name | |
| Last name | Fujii |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
4668550
Address
65,Tsurumai-cho,Showa-ku,Nagoya,Aichi
TEL
052-744-2245
Homepage URL
fjt@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate School of Medicine
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
Nagoya University
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
Tel
052-744-2245
fjt@med.nagoya-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
| 2013 | Year | 11 | Month | 08 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/33532687/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/33532687/
Number of participants that the trial has enrolled
74
Results
We did not demonstrate a clinical impact of right-half dissection of the SMA nerve plexus on locoregional recurrence or survival. Therefore, the prophylactic dissection of the SMA nerve plexus is unnecessary given that refractory diarrhea could be induced by this technique.
Results date posted
| 2022 | Year | 11 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Pancreatic head cancer
Participant flow
randomized
Adverse events
diarrhea
Outcome measures
local recurrence rate at 2 years after surgery.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2013 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2014 | Year | 01 | Month | 04 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | 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
| 2013 | Year | 11 | Month | 08 | Day |
Last modified on
| 2022 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014311
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