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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005722
Receipt No. R000006765
Scientific Title Randomized controlled multicenter trial assessing Roux-en-Y anastomosis of the pancreatic stump to prevent pancreatic fistula following distal pancreatectomy
Date of disclosure of the study information 2011/06/06
Last modified on 2014/10/08

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Basic information
Public title Randomized controlled multicenter trial assessing Roux-en-Y anastomosis of the pancreatic stump to prevent pancreatic fistula following distal pancreatectomy
Acronym Roux-en-Y anastomosis of the pancreatic stump following distal pancreatectomy
Scientific Title Randomized controlled multicenter trial assessing Roux-en-Y anastomosis of the pancreatic stump to prevent pancreatic fistula following distal pancreatectomy
Scientific Title:Acronym Roux-en-Y anastomosis of the pancreatic stump following distal pancreatectomy
Region
Japan

Condition
Condition disease of pancreatic body and tail
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective is to clarify Roux-en-Y anastomosis of the pancreatic stump decreases pancreatic fistula following distal pancreatectomy, compared with stapling closure of the pancreatic stump.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Incidence of pancreatic fistula defined by ISGPF
Key secondary outcomes 1) morbidity
2) mortality
3) postoperative hospital stay
4) new onset or worsening diabetes
5) nutritional status
6) quality of life
7) Incidence of pancreatic
fistula grade B/C
8) Incidence of pancreatic
fistula grade C
9) Incidence of intraabdominal
bleeding
10) Incidence of pancreatic
fistula based on thickness of
the pancreas

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Roux-en-Y anastomosis of the pancreatic stump following distal pancreatectomy
Interventions/Control_2 Stapling closure of the pancreatic stump following distal pancreatectomy
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) disease of pancreatic body and tail
2) PS (ECOG Performance Status Scale):0-1
3) Age: 20 years or older
4) distant metastases are not diagnosed preoperatively. Eligible for this clinical study when only distal pancreatectomy contributes to the favorable prognosis even if patients with pancreatic neuroendocrine cancer have the liver metastasis.
5) Adequate organ functions filled the following criteria within two weeks from enrollment:
1.White blood cell more than 3,500/mm3 or less than 12,000/mm3
2.Neutrophilic leukocyte more than 2,000/mm3
3.Platelet more than 100,000/mm3
4.Hemoglobin more than 9.0g/dL
5.Total bilirubin less than 2.0mg/dL
6.AST and ALT less than 150IU/L
7.Creatinine less than 1.5mg/dL
6)Patients who can provide written informed consent
Key exclusion criteria 1.Patients with severe liver cirrhosis or active hepatitis
2. Patients with respiratory illness that requires oxygen administration
3. .Patients with chronic renal failure requiring dialysis
4. Patients with active duplicative malignant disease affecting adverse event
5. Others, patients who are unfit for the study as determined by the attending physician
Target sample size 136

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroki Yamaue
Organization Wakayama Medical University, School of Medicine
Division name Second Department of Surgery
Zip code
Address 811-1 Kimiidera, Wakayama City, Wakayama Prefecture
TEL 073-441-0613
Email yamaue-h@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Manabu Kawai
Organization Wakayama Medical University, School of Medicine
Division name Second Department of Surgery
Zip code
Address 811-1 Kimiidera, Wakayama City, Wakayama Prefecture
TEL 073-441-0613
Homepage URL
Email kawai@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University, School of Medicine
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)

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

Other administrative information
Date of disclosure of the study information
2011 Year 06 Month 06 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
2011 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 06 Month 01 Day
Last follow-up date
2015 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 06 Month 05 Day
Last modified on
2014 Year 10 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006765

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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