UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053831 |
|---|---|
| Receipt number | R000061440 |
| Scientific Title | Multicenter prospective observational study of repeat endoscopic ultrasound-guided tissue acquisition for solid pancreatic lesions: REPANC STUDY |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/03/11 19:27:14 |
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Basic information
Public title
Multicenter prospective observational study of repeat endoscopic ultrasound-guided tissue acquisition for solid pancreatic lesions: REPANC STUDY
Acronym
The usefulness of repeat endoscopic ultrasound-guided tissue acquisition for solid pancreatic lesions: REPANC STUDY
Scientific Title
Multicenter prospective observational study of repeat endoscopic ultrasound-guided tissue acquisition for solid pancreatic lesions: REPANC STUDY
Scientific Title:Acronym
The usefulness of repeat endoscopic ultrasound-guided tissue acquisition for solid pancreatic lesions: REPANC STUDY
Region
| Japan |
Condition
Condition
solid pancreatic lesions
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness feasibility of repeat endoscopic ultrasound-guided tissue acquisition for solid pancreatic lesions
Basic objectives2
Others
Basic objectives -Others
Diagnostic accuracy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic accuracy
Key secondary outcomes
1. Sensitivity and specificity
2. Feasibility of rapid cytological diagnosis
3. Factors associated with diagnostic difficulty cases
4. Adverse events
5. Technical success
6. Overall survival
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. Over 20 years old
2. Patients with solid pancreatic lesions
3. Patients with performance status 2 or less
4. Patients requiring a re-puncture of EUS-TA for solid pancreatic lesions
Key exclusion criteria
1. Patients with unsuitable for re-puncture of EUS-TA
2. Patients with performance status 4
3. Difficulty with transgastric or transduodenal puncture
4. Patients with severe organ dysfunction
5. Pregnant patients
6. Patients unable to get consent
7. Patients considered ineligible for this study
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Nao |
| Middle name | |
| Last name | Fujimori |
Organization
Kyushu University
Division name
Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka City, Fukuoka
TEL
+81-92-642-5285
fujimori.nao.239@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Akiihsa |
| Middle name | |
| Last name | Ohno |
Organization
Kyushu University
Division name
Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka City, Fukuoka
TEL
+81-92-642-5285
Homepage URL
showa2644aki1aki2@yahoo.co.jp
Sponsor or person
Institute
Kyushu University
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
Ehime University
Oita University
Osaka Medical and Pharmaceutical University
Osaka Metropolitan University
Okayama University Hospital
Kagawa University
Kansai Medical University
Kansai Medical University Medical Center
Kindai University
Nagasaki University
Hyogo Medical University
Fukuoka University
Wakayama Medical University
Ehime Prefectural Central Hospital
Oita San-ai Medical Center
Osaka International Cancer Institute
Osaka Red Cross Hospital
Okanami General Hospital
Kitakyushu Municipal Medical Center
Kyushu Medical Center
Tane General Hospital
Japanese Red Cross Wakayama Medical Center
Beppu Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu university Center for clinical and translational research
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka City, Fukuoka 812-8582
Tel
+81-92-642-6254
ijkseimei@jimu.kyushu-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
九州大学病院（福岡県）、愛媛大学病院（愛媛県）、大分大学病院（大分県）、大阪医科薬科大学病院（大阪府）、大阪公立大学病院（大阪府）、岡山大学病院（岡山県）、香川大学病院（香川県）、関西医科大学病院（大阪府）、関西医科大学総合医療センター（大阪府）、近畿大学病院（大阪府）、長崎大学病院（長崎県）、兵庫医科大学病院（兵庫県）、福岡大学病院（福岡県）、和歌山県立医科大学病院（和歌山県）、愛媛県立中央病院（愛媛県）、大分三愛メディカルセンター（大分県）、大阪国際がんセンター（大阪府）、大阪赤十字病院（大阪府）、岡波総合病院（大阪府）、北九州市立医療センター（福岡県）、九州医療センター（福岡県）、多根総合病院（大阪府）、日本赤十字社和歌山医療センター（和歌山県）、別府医療センター（大分県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 11 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter prospective observational study
Management information
Registered date
| 2024 | Year | 03 | Month | 11 | Day |
Last modified on
| 2024 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061440
