UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044023 |
|---|---|
| Receipt number | R000049827 |
| Scientific Title | The usefulness of the stereomicroscopic on-site evaluation of the EUS-guided tissue acquisition for the preoperative diagnosis in patients with resectable or borderline resectable pancreatic cancer |
| Date of disclosure of the study information | 2021/05/01 |
| Last modified on | 2024/01/28 10:50:47 |
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Basic information
Public title
The usefulness of the stereomicroscopic on-site evaluation of the EUS-guided tissue acquisition for the preoperative diagnosis in patients with resectable or borderline resectable pancreatic cancer
Acronym
The usefulness of the SOSE of the EUS-TA for the preoperative diagnosis in patients with PC
Scientific Title
The usefulness of the stereomicroscopic on-site evaluation of the EUS-guided tissue acquisition for the preoperative diagnosis in patients with resectable or borderline resectable pancreatic cancer
Scientific Title:Acronym
The usefulness of the SOSE of the EUS-TA for the preoperative diagnosis in patients with PC
Region
| Japan |
Condition
Condition
resectable pancreatic cancer or borderline resectable pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the diagnostic accuracy obtained by the minimum number of punctures required for EUS-guided tissue acquisition with stereomicroscopic on-site evaluation in patients with resectable or borderline resectable pancreatic cancer, in multicenter prospective trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the sensitivity of SVWC cutoff value in EUS-TA with SOSE
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
procedure of the EUS-TA with SOSE
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) pancreatic tumor which are required EUS-TA for pathological diagnosis
2) patients whom suspected resectable or borderline resectable pancreatic cancer
3) adequate organ functions
4) providing written informed consent, and age =or >20
Key exclusion criteria
1) patients in which iodine-containing contrast agent cannot be used due to drug allergies or renal dysfunction
Target sample size
78
Research contact person
Name of lead principal investigator
| 1st name | Kosuke |
| Middle name | |
| Last name | Okuwaki |
Organization
Kitasato University School of Medicine
Division name
Gastroenterology
Zip code
252-0374
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa, Japan
TEL
+81-42-778-8111
kokuwaki@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Okuwaki |
Organization
Kitasato University School of Medicine
Division name
Gastroenterology
Zip code
252-0374
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa, Japan
TEL
+81-42-778-8111
Homepage URL
kokuwaki@kitasato-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Institutional Ethics Committee of Kitasato University Hospital
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa, Japan
Tel
+81-42-778-7756
rinri@med.kitasato-u.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
Kitasato University Hospital, Isehara Kyodo Hospital, JCHO Sagamino Hospital
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 01 | 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
| 2021 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 23 | Day |
Last modified on
| 2024 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049827
