UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005722 |
|---|---|
| Receipt number | 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 17:22:48 |
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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
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
kawai@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University, School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006765
