UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049961 |
|---|---|
| Receipt number | R000056904 |
| Scientific Title | A pilot study of the safety and efficacy of stapler for transection of the pancreatic parenchyma during pancreaticoduodenectomy |
| Date of disclosure of the study information | 2023/01/10 |
| Last modified on | 2024/09/18 09:29:38 |
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Basic information
Public title
A pilot study of the safety and efficacy of stapler for transection of the pancreatic parenchyma during pancreaticoduodenectomy
Acronym
A pilot study of the safety and efficacy of stapler for transection of the pancreatic parenchyma during pancreaticoduodenectomy
Scientific Title
A pilot study of the safety and efficacy of stapler for transection of the pancreatic parenchyma during pancreaticoduodenectomy
Scientific Title:Acronym
A pilot study of the safety and efficacy of stapler for transection of the pancreatic parenchyma during pancreaticoduodenectomy
Region
| Japan |
Condition
Condition
Diseases in the pancreatic head region
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Consideration the safety and usefulness of using stapler for transection of pancreatic parenchyma during pancreaticoduodenectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the rate of postoperative pancreatic fistula (ISGPF; GradeB or C)
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Patients judged to have a normal pancreas among those scheduled for pancreaticoduodenectomy.
2) The thickness of the pancreatic parenchyma can be cut with an automatic suturer.
3) ECOG Performance Status (PS) is 0-1.
4) Age over 20 years old.
5) The functions of major organs (bone marrow, heart, liver, kidney, lung, etc.) are maintained.
6) Has sufficient judgment to understand the content of the research, and has obtained written informed consent from the individual.
Key exclusion criteria
1) Patients with severe ischemic heart disease
2) Patients with cirrhosis or active hepatitis
3) Patients with dyspnea requiring oxygen administration due to interstitial pneumonia or pulmonary fibrosis
4) Patients undergoing dialysis for chronic renal failure
5) Cases requiring combined resection of surrounding organs
6) Patients considered to require arterial reconstruction of the superior mesenteric artery, common hepatic artery, celiac artery, etc.
7) Active double cancer that may affect adverse events or overall survival
8) Long-term oral steroid use that may affect adverse events
9) Patients who are complicated by psychosis or psychiatric symptoms and judged to be difficult to participate in the study
10) History of gastrectomy, colectomy or rectal resection
11) Patients who cannot use both iodine-based drugs and gadonium-based drugs due to severe drug allergies
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Kitahata |
Organization
Wakayama medical university
Division name
2nd department of surgery
Zip code
641-8510
Address
811-1 Kimiidera Wakayama
TEL
0734410613
yuji-kh@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Kitahata |
Organization
Wakayama medical university
Division name
2nd department of surgery
Zip code
641-8510
Address
811-1 Kimiidera Wakayama
TEL
0734410613
Homepage URL
yuji-kh@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama medical university
Institute
Department
Personal name
Funding Source
Organization
Wakayama medical university
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
Wakayama medical university
Address
811-1 Kimiidera Wakayama
Tel
9734472300
yuji-kh@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
| 2023 | Year | 01 | Month | 10 | 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
| 2022 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 06 | Month | 30 | Day |
Other
Other related information
not particular
Management information
Registered date
| 2023 | Year | 01 | Month | 04 | Day |
Last modified on
| 2024 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056904
