UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of postoperative complications and survival time after distal pancreatectomy with celiac axis en-bloc resection for pancreatic carcinoma
Title of the study (Brief title)	Investigation of postoperative complications and survival time after distal pancreatectomy with celiac axis en-bloc resection for pancreatic carcinoma
Region	Japan

Condition
Condition	Pancreatic carcinoma
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to verify the preventive procedure and survival impact of distal pancreatectomy with celiac axis en-bloc resection for pancreatic carcinoma.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The incidence of organ ischemia and survival time after distal pancreatectomy with celiac axis en-bloc resection
Key secondary outcomes

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients underwent distal pancreatectomy with celiac axis en-bloc resection at Wakayama Medical University from January 2005 to May 2017
Key exclusion criteria	Patients judged as inappropriate for this study by the research director
Target sample size	50

Research contact person
Name of lead principal investigator	Ken-ichi Okada
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Address	Kimiidera 811-1, Wakayama City
TEL	073-441-0613
Email	okada@wakayama-med.ac.jp

Public contact
Name of contact person	Ken-ichi Okada
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Address	Kimiidera 811-1, Wakayama City
TEL	073-441-0613
Homepage URL	http://www.wakayama-med-2ndsurg.jp/
Email	okada@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
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)

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 08 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 10 Day
Anticipated trial start date	2017 Year 07 Month 10 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	Observation items Patients information: age, gender, clinical record, diagnosis Operative information: operative method, postoperative complication CT findings

Management information
Registered date	2017 Year 08 Month 18 Day
Last modified on	2019 Year 02 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032881