UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052528 |
|---|---|
| Receipt number | R000059938 |
| Scientific Title | Phase I trial for lavage cytology tests collected by EUS-FNA for preoperative pancreatic cancer patients. |
| Date of disclosure of the study information | 2023/10/18 |
| Last modified on | 2023/10/18 00:11:48 |
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Basic information
Public title
Phase I trial for lavage cytology tests collected by EUS-FNA for preoperative pancreatic cancer patients.
Acronym
EUS-guided lavage cytology tests for preoperative pancreatic cancer patients
Scientific Title
Phase I trial for lavage cytology tests collected by EUS-FNA for preoperative pancreatic cancer patients.
Scientific Title:Acronym
Phase I trial of EUS-guided lavage cytology tests for preoperative pancreatic cancer patients
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Pancreatic cancer often has a relatively high incidence of peritoneal metastasis, and it is not uncommon for intraoperative cytology to test positive, making it impossible to continue with surgery. In order to avoid open laparotomy or diagnostic laparoscopy, there is a potential approach to confirm the presence of peritoneal metastasis preoperatively in resectable or borderline resectable pancreatic cancer cases. This approach involves percutaneous injection of physiological saline, followed by endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) to obtain lavage fluid from the peritoneal cavity via a transrectal approach.
While the safety of percutaneous saline injection and transrectal EUS-FNA has been individually confirmed, it remains unclear whether the overall sequence of these procedures is clinically feasible.
The aim of this study is to evaluate the safety of this sequence of techniques.
Basic objectives2
Others
Basic objectives -Others
Success Rate of the Technique
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety
Key secondary outcomes
Success Rate of the Technique
Positive Rate of Cytological Examination of Lavage Peritoneal Fluid using EUS-FNA
Volume of Peritoneal Fluid Collected by EUS-FNA
Biochemical Analysis of Peritoneal Fluid
Tumor Markers in Peritoneal Fluid
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
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Perform percutaneous ascites injection and perform transanal EUS-FNA to collect ascites.
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) Cases who the age at the time of obtaining consent is 20 years or older.
2) Cases who written consent has been obtained from the patient themselves.
3) Cases who a diagnosis of pancreatic cancer can be made through various imaging diagnostics.
3) Cases who it is believed that EUS-FNA can be safely performed.
Key exclusion criteria
Cases with concomitant cancers in other organs that are under treatment.
Cases with ascites or disseminated nodules on imaging.
Cases with a known allergy to lidocaine.
Cases that the attending physician deems unsuitable for inclusion in this trial.
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Hara |
Organization
Aichi Cancer Center Hospital
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 | Okun, |
| Last name | Okuno |
Organization
Aichi Cancer Center Hospital
Division name
Department of Gastroenterology
Zip code
464-8681
Address
1-1, Kanokoden, Chikusa-ku, Nagoya, Aichi, Japan
TEL
0527626111
Homepage URL
nokuno@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Aichi Cancer Center Hospital
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
IRC Aichi Cancer Center Hospital
Address
1-1, Kanokoden, Chikusa-ku, Nacoya, Aichi, Japan
Tel
0527626111
irb@aichi-cc.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 | 10 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 10 | Month | 18 | Day |
Last modified on
| 2023 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059938
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| Registered date | File name |
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