UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015942 |
|---|---|
| Receipt number | R000018550 |
| Scientific Title | Predictive risk factors for pancreatic fistula grade C after pancreaticoduodenectomy: prospective large observational study |
| Date of disclosure of the study information | 2014/12/14 |
| Last modified on | 2021/06/19 13:25:51 |
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Basic information
Public title
Predictive risk factors for pancreatic fistula grade C after pancreaticoduodenectomy: prospective large observational study
Acronym
Predictive risk factors for pancreatic fistula grade C after pancreaticoduodenectomy
Scientific Title
Predictive risk factors for pancreatic fistula grade C after pancreaticoduodenectomy: prospective large observational study
Scientific Title:Acronym
Predictive risk factors for pancreatic fistula grade C after pancreaticoduodenectomy
Region
| Japan | Asia(except Japan) |
Condition
Condition
Patients who undergo pancreaticoduodenectomy for pancreatic or periampullary lesions
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to clarify the risk factors for pancreatic fistula grade C
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To clarify the predictive risk factors to develop pancreatic fistula grade C by ISGPF classification
Key secondary outcomes
* To clarify the predictive risk factors of overall pancreatic fistula (grade A, grade B and grade C)
* To clarify the predictive risk factors of clinical relevant pancreatic fistula (grade B and grade C)
* To clarify the predictive risk factors for postpancreatecomy hemorrhage(PPH)
* cut-off value of drain amylase fluid on POD1 to distinguish pancreatic fistula grade C with grade A and grade B
* cut-off value of drain amylase fluid on POD1 to distinguish pancreatic fistula grade B and C with grade A
* morbidity
* 30-day mortality
* 90-day mortality
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 head or periampullary lesions to require
pancreaticoduodenectomy
2) Age: 20 years or older
3) PS (ECOG performance status scale) 0-1 at the time of enrollment
4) Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria
1) patients with severe respiratory disorder required oxygen inhalation
2) patients with severe liver dysfunction
3) patients with chronic renal failure with dialysis
4) patients who are unfit for this study as determined by the attending physician
5) patients requiring resection of other organs during pancreaticoduodenectomy
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Yamaue |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
641-8510
Address
811-1 Kimiidera, Wakayama, Japan
TEL
0734410613
seiko-h@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Seiko |
| Middle name | |
| Last name | Hirono |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
6418510
Address
811-1 Kimiidera, Wakayama, Japan
TEL
073-441-0613
Homepage URL
seiko-h@wakayama-med.ac.jp
Sponsor or person
Institute
Japanese Society of Hepato-Biliary-Pancreatic Surgery
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
Wakayama Medical University
Address
811-1 Wakayama Medical University
Tel
0734410613
seiko-h@wakayama-med.ac.jp
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
| 2014 | Year | 12 | Month | 14 | Day |
Related information
URL releasing protocol
None
Publication of results
Published
Result
URL related to results and publications
doi: 10.1002/jhbp.799. Epub 2020 Aug 6
Number of participants that the trial has enrolled
3022
Results
Among 2762 patients, 46 patients (1.7%) developed Grade C POPF after PD. The mortality rate of the 46 patients with Grade C POPF was 37.0%. On the multivariate analysis, six independent risk factors for Grade C POPF were found; BMI > 25.0 kg/m2 , chronic steroid use, preoperative serum albumin <3.0 mg/dL, soft pancreas, operative time >480 minutes, and intraoperative transfusion. The c-statistic of our risk scoring model for Grade C POPF using these risk factors was 0.77.
Results date posted
| 2021 | Year | 06 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who undergo pancreatoduodenectomy
Participant flow
3022 patients were enrolled in this study and 2762 patients were analyzed.
Adverse events
None
Outcome measures
Risk factors associated with grade C postoperative pancreatic fistula
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2014 | Year | 11 | Month | 21 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: prospective observational study
Target number of subjects: 3,000 patients
Study period: 3 years and 6 months
Registration period: 3 years
Subjects: Patients who undergo pancreaticoduodenectomy for pancreatic or periampullary lesions in Japan and Taiwan
Primary endpoint: To clarify the predictive risk factors to develop pancreatic fistula grade C by ISGPF classification
Secondary endpoints:
1) To clarify the predictive risk factors of overall pancreatic fistula (grade A, B and C)
2) To clarify the predictive risk factors of clinical relevant pancreatic fistula (grade B and C)
3) To clarify the predictive risk factors for postpancreatecomy hemorrhage
4) Cut-off value of drain amylase fluid on POD1 to distinguish pancreatic fistula grade C with grade A and B
5) Cut-off value of drain amylase fluid on POD1 to distinguish pancreatic fistula grade B and C with grade A
6) morbidity
7) 30-day mortality
8) 90-day mortality
Management information
Registered date
| 2014 | Year | 12 | Month | 14 | Day |
Last modified on
| 2021 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018550
