UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective cohort study of laparoscopic pancreaticoduodenectomy.
Title of the study (Brief title)	Prospective cohort study of laparoscopic pancreaticoduodenectomy.
Region	Japan

Condition
Condition	Patients who need pancreaticoduodenectomy
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To identify the relevance of patient background and the frequency of postoperative complications or patient QOL, who underwent laparoscopic pancreaticoduodenectomy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Postoperative complications
Key secondary outcomes	Length of ostoperative hospital stay

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Younger than 80 years old and older than 20 years old at current study registration Performance status 0 or 1 Diagnosed to need pancreatoduodenectomy by image before an operation No lymph node metastasis or distant metastasis by image A participant receives enough
Key exclusion criteria	Presence the past history of epigastric region open surgery Presence the past history of COPD or myocardial infarction Cancellation of the anticoagulant is impossible During the pregnancy or the nursing
Target sample size	10

Research contact person
Name of lead principal investigator	Chikara Kunisaki
Organization	Yokohama City University Medical Center
Division name	Gastroenterological Center
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Email	s0714@med.yokohama-cu.ac.jp

Public contact
Name of contact person	Yuta Minami
Organization	Yokohama City University Medical Center
Division name	Gastroenterological Center
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Homepage URL
Email	minayuu@zd6.so-net.ne.jp

Sponsor
Institute	Yokohama City University Medical Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	JAPAN

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	横浜市立大学附属市民総合医療センター（神奈川県）

Other administrative information
Date of disclosure of the study information	2014 Year 09 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 08 Month 01 Day
Anticipated trial start date	2014 Year 09 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	Unpublished
URL releasing results
Results
Other related information	Single center prospective cohort study to evaluate the presence of complications to need the treatment that occurred within three years after laparoscopic pancreatoduodenectomy

Management information
Registered date	2014 Year 08 Month 26 Day
Last modified on	2018 Year 03 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017403