UMIN-CTR Clinical Trial

Basic information
Public title	Laparoscopy-assisted (pylorus preserved) pancreatoduodenectomy for reduction of surgical invasiveness
Acronym	Laparoscopy-assisted pancreatoduodenectomy
Scientific Title	Laparoscopy-assisted (pylorus preserved) pancreatoduodenectomy for reduction of surgical invasiveness
Scientific Title:Acronym	Laparoscopy-assisted pancreatoduodenectomy
Region	Japan

Condition
Condition	The patient who receives pancreatoduodenectomy
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Reducing of surgical invasiveness
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Patient satisfaction Evaluation of the patient satisfaction by a patient questionnaire
Key secondary outcomes	Incidence rate of postoperative complications Postoperative hospitalization days

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Patients with periampullary lesions who will be treated until 1/31/2017
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	1.Patients 20years old over(At the time of hospitalization) 2.Patients with periampullary lesions who will be treated. 3.Patients who have been informed and have understood the full explanation of this study, and have agreed and given prior written consent.
Key exclusion criteria	1.Less than 20 years old 2.The cancer patient who accepts lymph node metastases by diagnostic imaging in preoperation 3.The patient whom it is judged to need blood vessel merger excision by video diagnosis in preoperation 4.The patient who is judged to be inappropriate by the examination medical attendant
Target sample size	80

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Susumu Eguchi
Organization	Nagasaki University Hospital
Division name	Department of Surgery
Zip code
Address	1-7-1 Sakamoto,Nagasaki,JAPAN
TEL	095-819-7316
Email	sueguchi@nagasaki-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Amane Kitasato
Organization	Nagasaki University Hospital
Division name	Department of Surgery
Zip code
Address	1-7-1 Sakamoto,Nagasaki,JAPAN
TEL	095-819-7316
Homepage URL
Email	kitasato@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University Hospital
Institute
Department

Funding Source
Organization	none
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
Email

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 02 Month 26 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	Completed
Date of protocol fixation	2014 Year 01 Month 29 Day
Date of IRB	2014 Year 04 Month 28 Day
Anticipated trial start date	2014 Year 04 Month 29 Day
Last follow-up date	2017 Year 01 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	2014 Year 02 Month 26 Day
Last modified on	2019 Year 03 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015488