UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004838 |
|---|---|
| Receipt number | 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 14:38:44 |
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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
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
kshimada@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005761
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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