UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect and safety of invagination pacreaticojejunostomy for distal pancreatectomy
Title of the study (Brief title)	Invagination pacreaticojejunostomy for distal pancreatectomy
Region	Japan

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

Objectives
Narrative objectives1	To investigate sefety and efficacy of invagination pancreaticojejunnostomy for distal pancreatectomy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of postoperative pancreatic fistula
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Invagination pancreaticojejunostomy
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who are scheduled to undergo open distal pancreatectomy
Key exclusion criteria	Patients who are scheduled to resect pancreas at right side of portal vein.
Target sample size	35

Research contact person
Name of lead principal investigator	Yasuhiro Shimizu
Organization	Aichi Cancer Center Hospital
Division name	Department of Gastroenterological Surgery
Address	1-1 Kanokoden Chikusa-ku Nagoya-City Aichi
TEL	0527626111
Email	yshimizu@aichi-cc.jp

Public contact
Name of contact person	Seiji Natsume
Organization	Aichi Cancer Center Hospital
Division name	Department of Gastroenterological Surgery
Address	1-1 Kanokoden Chikusa-ku Nagoya-City Aichi
TEL	0527626111
Homepage URL
Email	snatsume@aichi-cc.jp

Sponsor
Institute	Aichi Cancer Center Hospital
Institute
Department

Funding Source
Organization	Aichi Cancer Center Hospital
Organization
Division
Category of Funding Organization	Other
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	2018 Year 03 Month 23 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 03 Month 16 Day
Anticipated trial start date	2018 Year 03 Month 23 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

Management information
Registered date	2018 Year 03 Month 23 Day
Last modified on	2018 Year 03 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036371