UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040173 |
|---|---|
| Receipt number | R000045799 |
| Scientific Title | Evaluation of the clinical utility of shear wave elastography and dispersion slope measurement in pancreatic cancer |
| Date of disclosure of the study information | 2020/04/15 |
| Last modified on | 2023/10/18 19:15:39 |
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Basic information
Public title
Evaluation of the clinical utility of shear wave elastography and dispersion slope measurement in pancreatic cancer
Acronym
Shear wave elastgraphy and dispersion in pancreatic cancer
Scientific Title
Evaluation of the clinical utility of shear wave elastography and dispersion slope measurement in pancreatic cancer
Scientific Title:Acronym
Shear wave elastgraphy and dispersion in pancreatic cancer
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Laboratory medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the correlation between shear wave elastography and dispersion values in tumor and non-tumor sites in patients with pancreatic cancer, and their association with histopathological findings.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of shear wave dispersion slope values between pancreatic tumor sites and non-tumor sites before chemotherapy.
Key secondary outcomes
Comparison of shear wave dispersion slope values between pancreatic tumor sites and non-tumor sites before chemotherapy.
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. Pancreatic cancer patients planning to receive chemotherapy
2. Pancreatic cancer patients pathologically diagnosed as adenocarcinoma
3. Patients received sufficient explanations about the study and voluntary gave consent
Key exclusion criteria
1. Patients pathologically diagnosed as carcinomas other than adenocarcinoma
2. Patients who could not detect pancrease with abdominal echo or could not measure share wave imaging because of their figures or other reasons
3. Patients pregnant ,breast feeding patients, or possibly pregnant patients
4. Patients recognized as inappropriate
Target sample size
73
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Kuwatani |
Organization
Hokkaido University Hospital
Division name
Division of Endoscopy
Zip code
060-8638
Address
Hokkaido University Hospital Kita15, Nishi7, Kita-Ku, Sapporo Hokkaido 060-8638, Japan
TEL
011-716-1161
mkuwatan@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Yunosuke |
| Middle name | |
| Last name | Takishin |
Organization
Hokkaido University Faculty of Medicine and Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
060-8638
Address
Hokkaido University Hospital Kita15, Nishi7, Kita-Ku, Sapporo Hokkaido 060-8638, Japan
TEL
011-716-1161
Homepage URL
ofmycloud@live.jp
Sponsor or person
Institute
Hokkaido University Faculty of Medicine and Graduate School of Medicine, Department of Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Faculty of Medicine and Graduate School of Medicine, Department of Gastroenterology and Hepatology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Hospital Division of Clinical Research Administration
Address
Hokkaido University Hospital Kita14, Nishi5, Kita-Ku, Sapporo Hokkaido 060-8648, Japan
Tel
0117067639
crjimu@hump.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
| 2020 | Year | 04 | Month | 15 | 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
71
Results
The median shear wave dispersion slope (SWD) was 12.20 m/sec/kHz [IQR: 2.87] in the pancreatic cancer site and 13.57 m/sec/kHz (IQR: 4.15) in the non-cancer site (p=0.005). The median shear wave elasticity (SWE) was 8.18 kPa in the pancreatic cancer site and 6.14 kPa in the non-cancer site (p<0.001).
The score of inflammation in histopathological evaluation was correlated with SWD(rs=0.42, p<0.001).
There were no significant changes in the SWD and SWE before and after chemotherapy.
Results date posted
| 2021 | Year | 11 | Month | 14 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Currently submitting to a journal.
Date of the first journal publication of results
Baseline Characteristics
56 patients were registered in the study.
The median age was 72 years, gender was 36 males and 22 females, and the median body mass index was 21.8 kg/m2.
Tumors were localized in the head of the pancreas in 35 cases and the tail of the pancreas in 23 cases, and distant metastasis was observed in 17 cases.
Laboratory findings included a serum total bilirubin level of 2.0 mg/dL or higher in 14 cases, a serum CEA level of 5 ng/ml or higher in 25 cases, and a serum CA19-9 level of 37 U/ml or higher in 48 cases.
Translated with www.DeepL.com/Translator (free version)
Participant flow
71 patients with suspected pancreatic cancer were provisionally enrolled in the study and first measurement of shear wave dispersion slopes and elasticities were underwent.
Of the 67 patients who could be measured without any problem, EUS-FNA was performed in 62 patients, and 56 patients who were diagnosed as pancreatic ductal carcinoma by histopathological examination were registered in this study.
31 patients underwent chemotherapy at our hospital, and 30 patients underwent the second measurement of shear wave dispersion slopes and elasticities.
Adverse events
None
Outcome measures
The primary endpoint is the change in dispersion slope values in pancreatic cancer patients before and after chemotherapy.
Secondary endpoints are to compare dispersion slope and elastography values of pancreatic cancer patients between pancreatic cancer and non-cancerous sites, and to correlate EUS-FNA with histopathological evaluation and clinical factors.
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 08 | Month | 29 | Day |
Other
Other related information
The results of this study were published in the April 2023 Journal of Gastroenterology and Hepatology.
Management information
Registered date
| 2020 | Year | 04 | Month | 15 | Day |
Last modified on
| 2023 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045799
