UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036528 |
|---|---|
| Receipt number | R000041611 |
| Scientific Title | Multicenter prospective study to assess the efficacy of macroscopic on-site quality evaluation during EUS-FNB |
| Date of disclosure of the study information | 2019/04/17 |
| Last modified on | 2024/06/19 21:03:07 |
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Basic information
Public title
Multicenter prospective study to assess the efficacy of macroscopic on-site quality evaluation during EUS-FNB
Acronym
Multicenter prospective study to assess the efficacy of macroscopic on-site quality evaluation during EUS-FNB
Scientific Title
Multicenter prospective study to assess the efficacy of macroscopic on-site quality evaluation during EUS-FNB
Scientific Title:Acronym
Multicenter prospective study to assess the efficacy of macroscopic on-site quality evaluation during EUS-FNB
Region
| Japan |
Condition
Condition
Pancreatic mass
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the optimal visible core length required in the pathological diagnosis in EUS-FNB using a Franseen needle.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the optimal whitish material length required in the pathological diagnosis in EUS-FNB using a Franseen needle.
Key secondary outcomes
Factor affecting correct diagnosis
The relationship between whitish material length and amount of sample.
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
1 Pancreatic lesions that was detected by imaging examination (e.g. CT, MRI, PET-CT, US, and EUS) and required pathological diagnosis.
2 Age >=20 y
3 Ability to understand and willingness to sign a written statement of informed consent
Key exclusion criteria
1 ECOG PS 4
2 Patients who receive anticoagulant agent.
3 Pregnant or possibly pregnant women.
4 Bleedinfg tendency
5 Patients who are judged inappropriate by medical examine.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Hirotoshi |
| Middle name | |
| Last name | Ishiwatari |
Organization
Shizuoka Cancer Center
Division name
Division of Endoscopy
Zip code
411-8777
Address
1007, Shimonagakubo, Nagaizumicho, Suntougun, Shizuoka
TEL
0559895222
h.ishiwatari@scchr.jp
Public contact
Name of contact person
| 1st name | Hirotoshi |
| Middle name | |
| Last name | Ishiwatari |
Organization
Shizuoka Cancer Center
Division name
Division of Endoscopy
Zip code
411-8777
Address
1007, Shimonagakubo, Nagaizumicho, Suntougun, Shizuoka
TEL
0559895222
Homepage URL
h.ishiwatari@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
Funding Source
Organization
none
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, Nagaizumicho, Suntougun, Shizuoka
Tel
0559895222
h.ishiwatari@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
| 2019 | Year | 04 | Month | 17 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1111/den.14116
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/den.14116
Number of participants that the trial has enrolled
108
Results
Macroscopic visible core (MVC) length correlated positively with histological sample quantity(p<0.01). On multivariate analysis, MVC length over30 mm was a significant factor affecting suitability for next-generation sequencing (NGS) (odds ratio 6.19). Histologic diagnostic yield correlated positively with MVC length(p=0.01);however, there was no positive correlation between MVC length and overall(histology plus cytology) diagnostic yield.
Results date posted
| 2024 | Year | 06 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We included patients(age over 20 years) with solid pancreatic masses, who were scheduled to undergo EUS-TA. The patients who met any of the following criteria were excluded: European Cooperative Oncology Group performance status of 4; bleeding tendency (platelet count under 50,000, prothrombin time-international normalized ratio over1.5) or use of antiplatelet drugs; possible or confirmed pregnancy; pathological diagnosis already obtained by other methods; or refusal to participate in the study.
Participant flow
EUS-TA was planned for 108 patients. Among them, some patients were excluded for the following reasons: no pancreatic mass on EUS (n = 4), protocol violation (n = 1), and pancreatic cystic lesion (n = 1). Therefore, 204 passes from 102 patients were analyzed.
Adverse events
None
Outcome measures
The following measures were analyzed on a per-pass basis to　elucidate the performance of one needle pass. The endpoints　included evaluating the respective correlations of MVC length with histological sample quantity, and pathological diagnostic accuracy and sensitivity. The correct pathological diagnosis by EUS-TA was defined as a match between the pathological and final diagnosis. Diagnostic accuracy was defined as the sum of the number of correct pathological diagnoses divided by the total number of analyzed lesions.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 03 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the optimal whitish material length required in the pathological diagnosis in EUS-FNB using a Franseen needle.
Management information
Registered date
| 2019 | Year | 04 | Month | 16 | Day |
Last modified on
| 2024 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041611
