UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060781 |
|---|---|
| Receipt number | R000069540 |
| Scientific Title | Phase II Trial: Evaluation of the Clinical Utility of Peritoneal Lavage Cytology Using EUS-FNA in Pancreatic Cancer without Apparent Peritoneal Dissemination on Imaging |
| Date of disclosure of the study information | 2026/02/27 |
| Last modified on | 2026/02/27 18:52:49 |
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Basic information
Public title
Phase II Trial: Evaluation of the Clinical Utility of Peritoneal Lavage Cytology Using EUS-FNA in Pancreatic Cancer without Apparent Peritoneal Dissemination on Imaging
Acronym
A Phase II study of EUS-FNA lavage cytology in pancreatic cancer
Scientific Title
Phase II Trial: Evaluation of the Clinical Utility of Peritoneal Lavage Cytology Using EUS-FNA in Pancreatic Cancer without Apparent Peritoneal Dissemination on Imaging
Scientific Title:Acronym
A Phase II study of EUS-FNA lavage cytology in pancreatic cancer
Region
| Japan |
Condition
Condition
Pancreatic cancer patients without imaging evidence of peritoneal metastasis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Pancreatic cancer may be accompanied by occult peritoneal dissemination that cannot be detected by imaging, regardless of resectability status or the presence of other distant metastases. This risk is considered to be higher in patients with elevated tumor markers.
This study targets patients with pancreatic cancer who have no apparent peritoneal dissemination on imaging. In these patients, peritoneal lavage cytology using EUS-FNA will be performed to determine the positivity rate of occult peritoneal dissemination, with the aim of contributing to more accurate staging and the selection of optimal treatment strategies for individual patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The positivity rate of peritoneal lavage cytology using this procedure
Key secondary outcomes
Safety
Procedure success rate
Prognosis
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Lavage cytology using EUS-FNA
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. Patients aged greater than or equal to 20 years at the time of informed consent.
2. Patients who have provided written informed consent.
3. Patients with an ECOG Performance Status of 0 or 1.
4. Patients diagnosed with pancreatic cancer without apparent peritoneal dissemination on imaging, regardless of the presence of distant metastases other than peritoneal dissemination, provided that conversion surgery may be considered.
5. Patients considered eligible for safe performance of EUS-FNA.
Key exclusion criteria
1. Patients with another active malignancy under treatment.
2. Patients with moderate or greater ascites or detectable peritoneal nodules.
3. Patients with a history of upper gastrointestinal surgery.
4. Patients considered inappropriate for this study at the discretion of the treating physician.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Hara |
Organization
Aichi Cancer Center
Division name
Department of Gastroenterology
Zip code
464-8681
Address
1-1, Kanokoden, Chikusa-ku, Nagoya, Aichi, Japan
TEL
0527626111
khara@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Nozomi |
| Middle name | |
| Last name | Okuno |
Organization
Aichi Cancer Center
Division name
Department of Gastroenterology
Zip code
464-8681
Address
1-1, Kanokoden, Chikusa-ku, Nagoya, Aichi, Japan
TEL
0527626111
Homepage URL
https://cancer-c.pref.aichi.jp/department/clinical-research
nokuno@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center
Institute
Department
Personal name
Funding Source
Organization
funded by institutional resources
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
IRB, Aichi Cancer Center Hospital
Address
1-1, Kanokoden, Chikusa-ku, Nagoya, Aichi, Japan
Tel
0527626111
irb-jimu@aichi-cc.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2025-0-625
Org. issuing International ID_1
Aichi Cancer Center
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 27 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 03 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 27 | Day |
Last modified on
| 2026 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069540
