UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of efficiency of mesenteric approach during pancreaticoduodenectomy for pancreatic cancer
Title of the study (Brief title)	Evaluation of efficiency of mesenteric approach during pancreaticoduodenectomy
Region	Japan

Condition
Condition	Patients with pancreatic ductal adenocarcinoma
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	to evaluate of clinical benefits of mesenteric approach during pancreaticoduodenectomy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood loss volume, R0 rate
Key secondary outcomes	operative time, recurrence rate, overall survival, disease free survival

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	pancreatic cancer patients undergoing pancreaticoduodenectomy
Key exclusion criteria	patients without pathological diagnosis of pancreatic ductal adenocarcinoma
Target sample size	237

Research contact person
Name of lead principal investigator	Seiko Hirono
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Address	811-1 Kimiidera, Wakayama, Japan
TEL	073-441-0613
Email	seiko-h@wakayama-med.ac.jp

Public contact
Name of contact person	Seiko Hirono
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Address	811-1 Kimiidera, Wakayama, Japan
TEL	073-441-0613
Homepage URL
Email	seiko-h@wakayama-med.ac.jp

Sponsor
Institute	Second Department of Surgery, Wakayama Medical University
Institute
Department

Funding Source
Organization	Second Department of Surgery, Wakayama Medical University
Organization
Division
Category of Funding Organization	Self funding
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	2017 Year 02 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 12 Day
Anticipated trial start date	2017 Year 01 Month 12 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	Mesenteric approach could reduce intraoperative blood loss volume in both resectable and borderline resectable (BR) PDAC during pancreaticoduodenectomy (PD). In resectable PDAC, mesenteric approach could increase R0 rate and improve the overall survival (OS), however, in BR PDAC, could not do them. Therefore, resectable PDAC has oncological benefits of mesenteric approach, however, only surgical method might not give the oncological benefit fo BR PDAC might.
Other related information	Retrospective observable study Evalustion for the efficiency of mesenteric approach for pancreatic cancer

Management information
Registered date	2017 Year 02 Month 20 Day
Last modified on	2017 Year 08 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029996