UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058695 |
|---|---|
| Receipt number | R000066880 |
| Scientific Title | Research on the diagnosis of pancreatic and biliary tract diseases based on acetone concentrations in duodenal fluid |
| Date of disclosure of the study information | 2025/08/13 |
| Last modified on | 2025/08/05 00:34:04 |
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Basic information
Public title
Research on the diagnosis of pancreatic and biliary tract diseases based on acetone concentrations in duodenal fluid
Acronym
Diagnosis by duodenal fluid acetone concentration
Scientific Title
Research on the diagnosis of pancreatic and biliary tract diseases based on acetone concentrations in duodenal fluid
Scientific Title:Acronym
Diagnosis of pancreaticobiliary diseases by duodenal fluid acetone concentration
Region
| Japan |
Condition
Condition
Pancreaticobiliary diseases
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the diagnostic ability of acetone concentrations in duodenal fluid for distinguishing pancreaticobiliary malignant diseases from benign diseases
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Differences of acetone concentrations in duodenal fluid among malignant and benign pancreaticobiliary diseases
Key secondary outcomes
1) Differences of acetone concentrations in duodenal fluid among precancerous lesion and cancers at various stages
2) Differences of acetone concentrations in duodenal fluid among various pancreaticobiliary diseases
3) Differences of acetone concentrations in serum among various pancreaticobiliary diseases
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Individuals with elevated serum liver and biliary enzymes, elevated serum tumor markers (CA19-9, CEA, DUPAN-2, Span-1), and abnormalities in the pancreas or biliary tract as revealed by imaging tests (abdominal ultrasound, CT, MRI, PET-CT, EUS)
2) Individuals aged 18 years or older
3) Individuals who have received adequate explanation regarding participation in the study, have fully understood the details, and have provided written informed consent based on their own free will or that of their legal representative or proxy.
Key exclusion criteria
1) Individuals who cannot undergo oral or nasal endoscopy.
2) Individuals who are deemed unsuitable as research subjects by the attending physician.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Kuwatani |
Organization
Hokkaido University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
060-8648
Address
West 5, North 14, Kita-ku, Sapporo, Hokkaido
TEL
011-716-1161
mkuwatan@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Kuwatani |
Organization
Hokkaido University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
060-8648
Address
West 5, North 14, Kita-ku, Sapporo, Hokkaido
TEL
011-716-1161
Homepage URL
mkuwatan@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
West 5, North 14, Kita-ku, Sapporo, Hokkaido
Tel
81-11-706-7636
crjimu@huhp.hokudai.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
| 2025 | Year | 08 | Month | 13 | 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
| 2025 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1) Basic information on subjects: age, gender, diagnosis, medical history, family history, lifestyle history, treatment history
2) Hematological tests: hemoglobin, white blood cell count, white blood cell differential, platelet count
3) Blood biochemical tests: ALP, total bilirubin, total protein, albumin, AST, ALT, ALP, gamma-GTP, LDH, creatinine, BUN, Na, K, Cl, Ca, CEA, CA19-9, (if measured, DUPAN-2, SPAN-1), blood glucose, HbA1c (if measured), total cholesterol, triglycerides, HDL, LDL
4) Imaging Test Results: CT, MRI, US, EUS, PET-CT scan
5) Pathological examination results: Surgical resection specimens, EUS-FNA specimens, or transpapillary biopsy/brush cytology for pathological evaluation
6) Clinical diagnosis and clinical course: In cases where malignant findings are obtained from surgical resection specimens, EUS-FNA specimens, or transpapillary biopsy or brush cytology, this is considered the final diagnosis. For other cases, follow-up observation for at least 6 months is conducted, and if imaging shows progression of the lesion or the appearance of metastatic lesions, it is diagnosed as malignant; otherwise, it is diagnosed as benign. In cases of malignant tumors, clinical staging is also considered.
7) Treatment content and outcomes: Observation for up to 12 months after various examinations is conducted regarding anticancer treatment content (such as chemotherapy regimens or radiation therapy), treatment efficacy, and prognosis.
Management information
Registered date
| 2025 | Year | 08 | Month | 05 | Day |
Last modified on
| 2025 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066880
