UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052199 |
|---|---|
| Receipt number | R000059564 |
| Scientific Title | Perioperative Quality of Life Changes in Patients with Pancreaticoduodenectomy |
| Date of disclosure of the study information | 2023/09/14 |
| Last modified on | 2023/09/14 21:47:36 |
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Basic information
Public title
Perioperative Quality of Life Changes in Patients with Pancreaticoduodenectomy
Acronym
Perioperative Quality of Life Changes in Patients with Pancreaticoduodenectomy
Scientific Title
Perioperative Quality of Life Changes in Patients with Pancreaticoduodenectomy
Scientific Title:Acronym
Perioperative Quality of Life Changes in Patients with Pancreaticoduodenectomy
Region
| Japan |
Condition
Condition
Diseases requiring pancreatoduodenectomy (e.g., pancreatic cancer, bile duct cancer)
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify the perioperative quality of life changes in patients undergoing pancreaticoduodenectomy and their association with changes in physical function and nutritional status.
Basic objectives2
Others
Basic objectives -Others
observational study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of patients with decreased quality of life in the perioperative period after pancreaticoduodenectomy
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients for whom pancreatoduodenectomy is being planned
2. Patients must be 18 years of age or older at the time of enrollment.
3. including patients who underwent preoperative chemotherapy and/or radiation therapy
4. Patients who do not have severe disorders of major organs (liver, kidney, etc.) and meet the following criteria on clinical examination
a White blood cell count >=3,000/mm3
b Neutrophil count: >=1,000/mm3
c Hemoglobin: >=9.0g/dL
d Platelet count: >=100,000/mm3
e AST:<=100U/L, ALT:<=100U/L
f Total bilirubin: <=5mg/dL
g Creatinine: <=2mg/dL
5. Written consent has been obtained from the patient
Key exclusion criteria
1. Patients scheduled for hepato-pancreatpduedenectomy
2. Patients scheduled for pancreatic total resection (including residual pancreatectomy)
3. patients with psychiatric or neurological symptoms
4. patients who are judged to be difficult to perform the 6-minute walk test
5. patients who are deemed unsuitable for enrollment in this study by the physician in charge
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Teiichi |
| Middle name | |
| Last name | Sugiura |
Organization
Shizuoka Cancer Center
Division name
Division of Hepato-Biliary-Pancreatic Surgery
Zip code
4118777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Prefecture
TEL
+81-55-989-5222
t.sugiura@scchr.jp
Public contact
Name of contact person
| 1st name | Teiichi |
| Middle name | |
| Last name | Sugiura |
Organization
Shizuoka Cancer Center
Division name
Division of Hepato-Biliary-Pancreatic Surgery
Zip code
4118777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Prefecture
TEL
+81-55-989-5222
Homepage URL
t.sugiura@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Shizuoka Cancer Center
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
Shizuoka Cancer Center
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Prefecture
Tel
+81-55-989-5222
tansaku_office@scchr.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
| 2023 | Year | 09 | Month | 14 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study subjects will be evaluated at four time points: within 2 weeks before surgery, 1 month after surgery, 3 months after surgery, and 6 months after surgery.
Management information
Registered date
| 2023 | Year | 09 | Month | 13 | Day |
Last modified on
| 2023 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059564
