UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050540 |
|---|---|
| Receipt number | R000057557 |
| Scientific Title | Research on ingenious serial pancreatic juice aspiration cytological examination for abnormal pancreatic duct morphology and genetic analysis using pancreatic juice |
| Date of disclosure of the study information | 2023/03/10 |
| Last modified on | 2023/03/08 23:45:04 |
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Basic information
Public title
Research on ingenious serial pancreatic juice aspiration cytological examination for abnormal pancreatic duct morphology and genetic analysis using pancreatic juice
Acronym
Research on ingenious serial pancreatic juice aspiration cytological examination for abnormal pancreatic duct morphology and genetic analysis using pancreatic juice
Scientific Title
Research on ingenious serial pancreatic juice aspiration cytological examination for abnormal pancreatic duct morphology and genetic analysis using pancreatic juice
Scientific Title:Acronym
Research on ingenious serial pancreatic juice aspiration cytological examination for abnormal pancreatic duct morphology and genetic analysis using pancreatic juice
Region
| Japan |
Condition
Condition
early-stage pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
We aim to improve the prognosis of pancreatic cancer by devising an evaluation method for pancreatic juice obtained from endoscopic nasopancreatic drainage tubes and analyzing genetic mutations in the pancreatic juice to improve the positive diagnosis rate of serial pancreatic juice aspiration cytological examination and lead to an appropriate diagnosis of early pancreatic cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Establish a method for evaluating pancreatic juice stored in the drainage bag by comparing the total pancreatic juice volume obtained from the ENPD tube and the number and quality of cells contained in it with the presence, type, and amount of cell-fixing solution or proteolytic enzyme inhibitor placed in the drainage bag.
Key secondary outcomes
Correlation between the degree of pancreatic endocrine function and/or evaluation of the pancreas by CT/MRI/ultrasound imaging and total pancreatic fluid volume obtained from the ENPD tube
Changes in total pancreatic fluid volume and volume of pancreatic fluid obtained by aspiration before and after resumption of oral intake, and examination of the volume of pancreatic fluid submitted to cytological examination and the number and quality of cells contained in these samples.
Contrasting mutant DNA, metabolites and proteins in pancreatic juice with final diagnosis and postoperative pathology specimens
The extent of pancreatic duct morphology abnormalities, pH and/or temperature of the gastrointestinal wall and pancreatic juice, and comparison of the final diagnosis with breath hydrogen and microflora.
Relationship between salivary and fecal microbiota, breath hydrogen and pancreatic duct morphology abnormalities, pancreatic exocrine function, and gastrointestinal mucosal microbiota.
Identification of bacterial species specific to early-stage pancreatic cancer and their distribution in tissues by in situ hybridization
The success rate of making organoids from pancreatic juice obtained from ENPD tubes, the relationship between morphology and expressed genes and final diagnosis, and the identification of factors involved in tumor growth.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Scrape the mucosa of the gastrointestinal tract with a brush.
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
18 years or older adults with pancreatic duct morphology abnormalities suspected of early pancreatic cancer and undergoing SPACE with ENPD tube placement under ERCP in Nagoya univercity hospital.
Key exclusion criteria
Patients who are deemed ineligible for participation in this study by the principal investigator or a principal study investigator
Patients with difficulty in ENPD tube placement
Patients after pancreatic surgery
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Yamao |
Organization
Nagoya University Hospital
Division name
Department of Endoscopy
Zip code
466-8560
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
+81-52-741-2111
k-yamao@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Yamao |
Organization
Nagoya University Hospital
Division name
Department of Endoscopy
Zip code
4668560
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Aichi Japan
TEL
+81-52-741-2111
Homepage URL
k-yamao@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
self-financing
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
Ethics Committee
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8560, Japan
Tel
0527412111
ytakada@med.nagoya-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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 10 | 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
| 2023 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 12 | 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 | 03 | Month | 08 | Day |
Last modified on
| 2023 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057557
