UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045604 |
|---|---|
| Receipt number | R000052068 |
| Scientific Title | Patient characteristics and intraoperative factors predicting clinical relevant pancreatic fistula after pancreaticoduodenectomy |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2023/03/29 14:55:13 |
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Basic information
Public title
Patient characteristics and intraoperative factors predicting clinical relevant pancreatic fistula after pancreaticoduodenectomy
Acronym
Pancreatic fistula after pancreaticoduodenectomy
Scientific Title
Patient characteristics and intraoperative factors predicting clinical relevant pancreatic fistula after pancreaticoduodenectomy
Scientific Title:Acronym
Pancreatic fistula after pancreaticoduodenectomy
Region
| Japan |
Condition
Condition
Pancreaticoduodenectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Pancreatic fistula (PF) remains the most important cause of morbidity and mortality following pancreaticoduodenectomy (PD). Several studies have identified surgical risk factors associated with clinical relevant PF (Grade B or C) but few studies have focused on anesthetic aspects.
Basic objectives2
Others
Basic objectives -Others
The aim of the study is to validate predictive patient characteristics and intraoperative factors including depth of anesthesia of clinical relevant PF after PD.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Depth of anesthesia (bispectral index)
Key secondary outcomes
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
elective open pancreaticoduodenectomy
Key exclusion criteria
dialysis-dependent patients, patients with missing intraoperative data
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Nakasuji |
Organization
Kansai Electric Power Hospital
Division name
Department of Anesthesiology
Zip code
5530003
Address
2-1-7 Fukushima, Fukushima-ku, Osaka 553-0003, Japan
TEL
06-6458-5821
nakasuji.masato@c3.kepco.co.jp
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Nakasuji |
Organization
Kansai Electric Power Hospital
Division name
Department of Anesthesiology
Zip code
5530003
Address
2-1-7 Fukushima, Fukushima-ku, Osaka 553-0003, Japan
TEL
06-6458-5821
Homepage URL
nakasuji.masato@c3.kepco.co.jp
Sponsor or person
Institute
Kansai Electric Power Hospital
Institute
Department
Personal name
Funding Source
Organization
Kansai Electric Power Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Kansai Electric Power Hospital
Address
2-1-7 Fukushima, Fukushima-ku, Osaka 553-0003, Japan
Tel
06-6458-5821
koga.kazuhiro@c3.kepco.co.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
| 2021 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
https://anesth.or.jp/
Publication of results
Published
Result
URL related to results and publications
https://anesth.or.jp/
Number of participants that the trial has enrolled
76
Results
PF and non-PF group comprised 18 and 58 patients respectively.The patients in PF group had significant less ratio of type 2 diabetes mellitus (6 vs 36 %, PF vs non- PF group, p=0.015) and higher rate of patients with intraoperative bispecral index (BIS) less than 45 (67 vs 33 %, p=0.014). Logistic analysis showed that BIS < 45 and non- diabetes mellitus were independent risk factors for postoperative PF.
Results date posted
| 2023 | Year | 03 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients undergoing elective open PD from September 2013 to April 2021
Participant flow
The patients were divided into PF (Grade B or C) and non-PF (without PF or asymptomatic PF of Grade A) groups. We compared perioperative factors between the two groups and logistic analysis was used to identify the independent risk factors of PF.
Adverse events
None
Outcome measures
Patients' background and intra-postoperative factors
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this case-control retrospective study based on the past anesthetic records, patients undergoing elective open PD from September 2013 to April 2021 were divided into PF (Grade B or C) and non-PF (without PF or asymptomatic PF of Grade A) groups. We compared perioperative factors between the two groups and logistic analysis was used to identify the independent risk factors of PF.
Management information
Registered date
| 2021 | Year | 09 | Month | 29 | Day |
Last modified on
| 2023 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052068
