UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Multicenter, single-blind, randomized, parallel-group trial comparing Reinforced Reload with Tri-Staple with Tri-Staple during Distal Pancreatectomy
Title of the study (Brief title)	RETTS-DP trial
Region	Japan

Condition
Condition	Patients who underwent distal pancreatectomy
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whetehr use of Reinforced Reload with Tri-Staple can significantly reduce the incidence of pancreatic fistula compared with Tri-Staple.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of Grade B/C postoperative pancreatic fistula within one month after surgery
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Use of Reinforced Reload with Tri-Staple
Interventions/Control_2	Use of Tri-Staple
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 who underwent distal pancreatectomy 2.Performance Status(PS)is 0-1 of Eastern Cooperative Oncology Group(ECOG) 3.more than 20 years old 4.Patients without distant metastasis excepting for liver metastasis from neouroendcrine tumor 5.Patients whose function of main organs is maintained. 6.Patients who canunderstand the contents of this clinical trial
Key exclusion criteria	1.patients with severe ischemic heart disease(NYHA > III) 2.patients with grade C of liver damage 3.patients requred countiuous oxygen administration due to severe lung disease 4.patients who received dialysis 5.patients with active cancer disease that may influence perioerative adverse events. 6.Patients who enable to enroll this trial due to their mental illness. 7.Patients who reject to enroll this trial
Target sample size	120

Research contact person
Name of lead principal investigator	Yoshiaki Murakami
Organization	Hiroshima University Hospital
Division name	Gastrointestinal Surgery
Address	1-2-3,KASUMI, MINAMI-KU, Hiroshima, JAPAN
TEL	082-257-5215
Email	mura777@hiroshima-u.ac.jp

Public contact
Name of contact person	Naru Kondo
Organization	Hiroshima University Hospital
Division name	Gastrointestinal Surgery
Address	1-2-3,KASUMI, MINAMI-KU, Hiroshima, JAPAN
TEL	082-257-5215
Homepage URL
Email	k-naru-surg@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University Hospital
Institute
Department

Funding Source
Organization	No
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	広島大学病院（広島県）

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 11 Day
Anticipated trial start date	2016 Year 05 Month 18 Day
Last follow-up date	2018 Year 01 Month 31 Day
Date of closure to data entry	2018 Year 02 Month 28 Day
Date trial data considered complete	2018 Year 04 Month 30 Day
Date analysis concluded	2018 Year 11 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 05 Month 18 Day
Last modified on	2019 Year 02 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025457