UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Lapoaroscopic pancreatoduodenectomy evaluated by novel self-apprisal system. The surgical phase I trial.
Title of the study (Brief title)	Lap-PD surgical phase I
Region	Japan

Condition
Condition	periampullary tumor
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy of novel evaluation system for Lap-PD.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	The grade of achievement of Lap-PD
Key secondary outcomes	Perisurgical outcomes Surgical curability Length of incision Length of hospital stay

Base
Study type

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	To apply the laparoscopic approach to pancreatoduodenectomy
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Good performance status 2) 19<age<81 3) The fair or more function of major organs is mainteined. 4) No past history of upper abdominal surgery except laparoscopic cholesysteectomy 5) Written informed consent is obtained
Key exclusion criteria	1)Contraindications for pneumoperitomeum 2)The cases who were judged unsuitable for the trial by the attending doctor.
Target sample size	5

Research contact person
Name of lead principal investigator	Akio Saiura
Organization	Japanese foundation for cancer research, Cancer institute hospital
Division name	The dept of digestive and HBP surgery
Address	3-8-31, Ariake, Koto-ku, Tokyo
TEL	+81-3-3520-0111
Email	sukeyaubj@yahoo.co.jp

Public contact
Name of contact person	Yosuke Inoue
Organization	Japanese foundation for cancer research, Cancer institute hospital
Division name	The dept of digestive and HBP surgery
Address	3-8-31, Ariake, Koto-ku, Tokyo
TEL	+81-3-3520-0111
Homepage URL
Email	sukeyaubj@yahoo.co.jp

Sponsor
Institute	Japanese foundation for cancer research, Cancer institute hospital
Institute
Department

Funding Source
Organization	Japanese foundation for cancer research, Cancer institute hospital
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2014 Year 10 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 05 Month 05 Day
Anticipated trial start date	2013 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 10 Month 02 Day
Last modified on	2016 Year 10 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017823