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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004838
Receipt No. R000005761
Scientific Title Safety of stapler vs. non-stapler closure of the pancreatic remnant after distal pancreatectomy: a multicenter randomized controlled trial
Date of disclosure of the study information 2011/01/18
Last modified on 2014/01/07

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Basic information
Public title Safety of stapler vs. non-stapler closure of the pancreatic remnant after distal pancreatectomy: a multicenter randomized controlled trial
Acronym SNS-RCT
Scientific Title Safety of stapler vs. non-stapler closure of the pancreatic remnant after distal pancreatectomy: a multicenter randomized controlled trial
Scientific Title:Acronym SNS-RCT
Region
Japan

Condition
Condition Benign and malignant pancreatic neoplasms indicated for distal pancreatectomy
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Tha aim of this study is to evaluate the effectiveness of the two most common surgical techniques for distal pancreatectomy: stapler versus non-stapler closure of the pancreatic remnant
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Clinical pancreatic fistul rate
Key secondary outcomes Operative time, bleeding, chemical pancreatic fistula rate, duration of drain placement, complications, duration of hospital stay, severe complication rate

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Non-stapler closure: After mobilazation of the pancreatic body, the transection is performed with paen fracture method, surgical scalpel, or harmonic scalpel. After a ligation of the pancreatic duct, subsequent closure of the pancreatic remnant is achieved with a single stitched suture of the entire pancreatic remnant. No closure is available. The suture material of choice should be a slowly absorbable monofilament thread.
Interventions/Control_2 Stapler closure: Pancreatic resection and transection of the pancreatic body will be executed using a linear stapling device (Ethicon TLH60).
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
90 years-old >
Gender Male and Female
Key inclusion criteria 1)Non-malignant or malignant pancreatic neoplasms indicated for distal pancreatectomy
2)Expected survival time more than 3 months
3)Open distal pancreatectomy is feasible
4)ECOG performance status <3
5)No functinal disturvance of each organ
6)Age >=20, <90
7)Confirmation ofinformed consent
Key exclusion criteria 1)Chemotherapy, immunotherapy, or radiotherapy before operation
2)Possibility of total pancreaterctomy, or combined celiac artery resection
3)Severe comorbid illness needing postoperative care under ICU
4)Severe psychiatric or neurologic diseases
5)Pregnancy
6)Lack fo compliance
Target sample size 140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuaki Shimada
Organization National Cancer Center Hospital
Division name Hepatobiliary and pancreatic surgery division
Zip code
Address 5-1-1 Tsukiji; Chuo-ku, Tokyo Japan
TEL 03-3542-2511
Email kshimada@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuaki Shimada
Organization National Cancer Center Hospital
Division name Hepatobiliary and pancreatic surgery division
Zip code
Address 5-1-1 Tsukiji; Chuo-ku, Tokyo Japan
TEL 03-3542-2511
Homepage URL
Email kshimada@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization National Cancer Center Hospital
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s) A Grant-in-Aid for cancer research from the Ministry of Health, Welfare and Labor of Japan (21-7-5)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 国立がん研究センター中央病院

Other administrative information
Date of disclosure of the study information
2011 Year 01 Month 18 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 12 Month 21 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 15 Day
Last follow-up date
2013 Year 12 Month 01 Day
Date of closure to data entry
2013 Year 12 Month 31 Day
Date trial data considered complete
2014 Year 03 Month 01 Day
Date analysis concluded
2014 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 01 Month 07 Day
Last modified on
2014 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005761

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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