UMIN-CTR Clinical Trial

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
Email	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
Email	fjt@med.nagoya-u.ac.jp

Sponsor
Institute	Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014311