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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018834
Receipt No. 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

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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
Email 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
Email matsumotokazuyuki0227@yahoo.co.jp

Sponsor
Institute Okayama University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021786

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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