UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052674 |
|---|---|
| Receipt number | R000060098 |
| Scientific Title | Nationwide registry for needle tract seeding after endoscopic ultrasound-guided fine needle aspiration in pancreatic tumors |
| Date of disclosure of the study information | 2023/11/15 |
| Last modified on | 2023/11/01 19:59:30 |
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Basic information
Public title
Nationwide registry for needle tract seeding after endoscopic ultrasound-guided fine needle aspiration in pancreatic tumors
Acronym
Nationwide registry for needle tract seeding after EUS-FNA
Scientific Title
Nationwide registry for needle tract seeding after endoscopic ultrasound-guided fine needle aspiration in pancreatic tumors
Scientific Title:Acronym
Nationwide registry for needle tract seeding after EUS-FNA
Region
| Japan |
Condition
Condition
pancreatic tumor
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The Japan Pancreas Association conducted "A retrospective nationwide survey of needle tract tumor cell seeding (NTS) after endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for pancreatic tumors" to determined the incidence and prognosis of needle tract seeding after EUS-FNA. The incidence of needle tract seeding was found to be 0.330%. However, due to a retrospective study, it has limitations in the data collection.
Therefore, based on the results of this retrospective study, we conduct a prospective nationwide survey to examine the annual incidence of needle tract seeding and to elucidate the factors that contribute to the incidence and prognostic factors.
Basic objectives2
Others
Basic objectives -Others
We conduct a prospective nationwide survey to examine the annual incidence of needle tract seeding and to elucidate the factors that contribute to the incidence and prognostic factors.
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of needle tract seeding after EUS-FNA in patients receiving surgical resection of pancreatic tumors
Key secondary outcomes
Incidence of needle tract seeding after EUS-FNA in patients with resected pancreatic ductal carcinomas
Incidence of needle tract seeding after EUS-FNA in patients with resected pancreatic tumors other than ductal carcinomas
Factors associated with incidence of needle tract seeding after EUS-FNA
The time from EUS-FNA to the manifestation of needle tract seeding, size of NTS lesion, location of NTS lesion, and whether the tumor was resected or not
Prognosis of patients with needle tract seeding after EUS-FNA
Prognostic factors of needle tract seeding after EUS-FNA
Pathological examinations of resected NTS lesions
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
20 years of age or older
Patients with pancreatic lesions that are suspicious for malignancy on various imaging examinations
Patients with ECOG performance status 2 or lower
Patients who need histological diagnosis by EUS-FNA to decide the follow-up or to select the treatment methods
Patients who undergo transgastric EUS-FNA
Key exclusion criteria
Patients with blood vessels or other tumors in the puncture route on various imaging examinations performed prior to enrollment
Patients with bleeding tendency (PT INR > 1.5 or Plt < 50000 micro L)
Patients in whom antithrombotic drugs cannot be discontinued
Patients in whom the tumor cannot be visualized by EUS due to a history of gastrectomy, etc.
Patients with clear distant metastasis at the time of puncture or patients with pancreatic tumors which can be judged to be unresectable
Patients who are deemed inappropriate as subjects by the investigator (subinvestigator)
Target sample size
2900
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Kitano |
Organization
Wakayama Medical University
Division name
Second Department of Internal Medicine
Zip code
641-0012
Address
811-1 Kimiidera, Wakayama city, Wakayama
TEL
073-441-0627
kitano@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Reiko |
| Middle name | |
| Last name | Ashida |
Organization
Wakayama Medical University
Division name
Second Department of Internal Medicine
Zip code
641-0012
Address
Wakayama Medical University
TEL
0734410627
Homepage URL
nts@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Pancreas Society
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
Research Ethics Comittee of Wakayama Medical University
Address
811-1 Kimiidera, Wakayama city, Wakayama
Tel
073-441-0897
wa-rinri@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 | 11 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 02 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2023 | Year | 11 | Month | 01 | Day |
Last modified on
| 2023 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060098
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