UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018834 |
|---|---|
| Receipt number | R000021786 |
| Scientific Title | Efficacy and Safety of endoscopic ultrasound-guided ethanol ablation therapy for pancreatic neuroendocrine tumors: A Pilot Study |
| Date of disclosure of the study information | 2015/10/31 |
| Last modified on | 2019/03/14 16:35:00 |
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Basic information
Public title
Efficacy and Safety of endoscopic ultrasound-guided ethanol ablation therapy for pancreatic neuroendocrine tumors: A Pilot Study
Acronym
Ethanol ablation therapy for pancreatic neuroendocrine tumors
Scientific Title
Efficacy and Safety of endoscopic ultrasound-guided ethanol ablation therapy for pancreatic neuroendocrine tumors: A Pilot Study
Scientific Title:Acronym
Ethanol ablation therapy for pancreatic neuroendocrine tumors
Region
| Japan |
Condition
Condition
Pancreatic neuroendocrine tumor
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of EUS-guided ethanol ablation therapy for pancreatic neuroendocrine tumors
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complete ablation rate
(Treatment responses were assessed according to enhanced residual tumor areas on CE-CT)
Key secondary outcomes
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Ethanol injection into the tumor by using EUS
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)The diagnosis of p-NET(G1 or G2) was confirmed by pathology from a core biopsy specimen obtained by EUS-FNA(WHO 2010 classification)
2)Low suitability for surgery(ASA grade>=3) or refusal of surgery
3)The p-NET within 2 cm in diameter by using CE-CT
4)The p-NET with non-function or insulinoma
Key exclusion criteria
1)Severe allergy history against medical drug
2)Allergy for contrast medium
3)Allergy for ethanol
4)Cases that could not visualize or puncture by using EUS
5)Cases that were diagnosed NEC from a core biopsy specimen obtained by EUS-FNA(WHO2010 classification)
6)Located near the main pancreatic duct
7)PT<=50% or INR>=1.5
8)PLT<=50,000/uL
9)eGFR<=30 mL/min
10)Patients who administered more than 2 anti-thrombotic agent
11)Patients with performance status 2-4.
12)Patients with poor prognosis (less than 3-year)
13)Age<20
14)Patients without informed consent
15)Patients who are judged inappropriate by chief medical examiner
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hironari Kato |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology & Hepatology
Zip code
Address
2-5-1 Shikata-cho,Kita-ku Okayama-city Okayama
TEL
086-235-7219
drkatocha@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuyuki Matsumoto |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology & Hepatology
Zip code
Address
2-5-1 Shikata-cho,Kita-ku Okayama-city Okayama
TEL
086-235-7219
Homepage URL
matsumotokazuyuki0227@yahoo.co.jp
Sponsor or person
Institute
Okayama University Hospital
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
Address
Tel
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
| 2015 | Year | 10 | Month | 31 | Day |
Related information
URL releasing protocol
www.lib.okayama-u.ac.jp/www/acta/pdf/70_4_313.pdf
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
5
Results
A total of five patients were treated. The median size of the tumor was 10 mm (range 7-14). Of the five patients, three underwent an additional session. The median volume of ethanol injection per session was 0.8 (range: 0.3-1.0) mL, and the total was 1.0 (0.9-1.8) mL. Complete ablation at 1 month was achieved in 4 of the 5 tumors (80%). During one year of follow-up, none of the patients reported any procedure-related adverse events, and no malignancy or lymph node metastasis was noted.
Results date posted
| 2019 | Year | 03 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
No adverse event
Outcome measures
Complete ablation at 1 month was achieved in 4 of the 5 tumors (80%).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 14 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 14 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 14 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 27 | Day |
Last modified on
| 2019 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021786
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