UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050747 |
|---|---|
| Receipt number | R000057815 |
| Scientific Title | Frequency of needle tract seeding after transgastric EUS-TA in clinically resectable pancreatic tumors. |
| Date of disclosure of the study information | 2023/04/03 |
| Last modified on | 2023/09/25 11:21:26 |
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Basic information
Public title
Frequency of needle tract seeding after transgastric EUS-TA in clinically resectable pancreatic tumors.
Acronym
Frequency of needle tract seeding in pancreatic tumors
Scientific Title
Frequency of needle tract seeding after transgastric EUS-TA in clinically resectable pancreatic tumors.
Scientific Title:Acronym
Frequency of needle tract seeding in pancreatic tumors
Region
| Japan |
Condition
Condition
pancreatic malignant tumor
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In cases in which surgical resection is planned after transgastric EUS-FNA of a pancreatic mass located in the tail of the pancreas and suspected of being a malignant pancreatic tumor, we will mark the site of gastric mucosal puncture with a clip and perform EGD/EUS surveillance every year after FNA to determine the incidence of NTS in the gastric mucosa that served as the puncture site, the time to occurrence of NTS, the usefulness of EGD/EUS surveillance in the early detection of NTS and lesions other than NTS (recurrent findings and other lesions), factors associated with NTS, and the predictability of NTS.
The purpose of this study is to prospectively collect and review information on the frequency and duration of NTS in the gastric mucosa, the usefulness of EGD/EUS surveillance in the early detection of NTS and lesions other than NTS (recurrent findings and other lesions), factors associated with NTS, and the prognostic impact of NTS.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of needle tract seeding (NTS) and time to NTS recurrence in pancreatic resection neoplasms after EUS-FNA for pancreatic mass, examined separately for overall, pancreatic cancer, and pancreatic malignant neoplasm other than pancreatic cancer.
Key secondary outcomes
Frequency of needle tract seeding (NTS) and time to NTS recurrence in unresectable pancreatic neoplasmsafter EUS-FNA for pancreatic mass, examined separately for overall, pancreatic cancer, and pancreatic malignant neoplasm other than pancreatic cancer.
Frequency of NTS detected by EGD/EUS
Frequency of non-NTS lesions detected on EGD/EUS
Frequency of complications in EGD/EUS examinations
Image Characteristics of NTS and their associated factors
Prognosis of NTS cases and their associated factors
Non-NTS recurrence sites and their frequency
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
From one year after EUS-FNA, esophagogastroduodenoscopy (EGD) and endoscopic ultrasonography (EUS) are performed every year for three years.
Marking is performed at the puncture site with a clip during EUS-FNA procedure.
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
Resectable pancreatic cancer occured at pancreatic body or tail
Patients who require pathological diagnosis for therapeutic purposes
Patients who wil be (or was) performed EUS-FNA for pancreatic tumor transgastrically
Patients aged more than 18 years
Patients for whom informed consent has been obtained
Key exclusion criteria
Patients undergoing percutaneous transhepatobiliary drainage (PTBD) or endoscopic biliary drainage (EUS-BD)
Patients after total gastrectomy or B-II reconstruction
Patients who have already undergone surgical pancreatic resection
Patients who have passed more than 1 year since the date of EUS-FNA for pancreatic mass
Patients whose physician judges them inappropriate for enrollment in this study
Target sample size
480
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Takehara |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
565-0871
Address
Yamadaoka 2-2, Suita, Osaka, Japan
TEL
0668793621
takehara@gh.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Minoru |
| Middle name | |
| Last name | Shigekawa |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
565-0871
Address
Yamadaoka 2-2, Suita, Osaka, Japan
TEL
0668793621
Homepage URL
m-shigekawa@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
None
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
Osaka University Hospital Institutional Review Board
Address
Yamadaoka 2-2, Suita, Osaka, Japan
Tel
06-6210-8289
rinri@hp-crc.med.osaka-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 | 04 | Month | 03 | 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
| 2022 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 03 | 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
Management information
Registered date
| 2023 | Year | 04 | Month | 01 | Day |
Last modified on
| 2023 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057815
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| Registered date | File name |
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| Registered date | File name |
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