Unique ID issued by UMIN | UMIN000018834 |
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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 |
Efficacy and Safety of endoscopic ultrasound-guided ethanol ablation therapy for pancreatic neuroendocrine tumors: A Pilot Study
Ethanol ablation therapy for pancreatic neuroendocrine tumors
Efficacy and Safety of endoscopic ultrasound-guided ethanol ablation therapy for pancreatic neuroendocrine tumors: A Pilot Study
Ethanol ablation therapy for pancreatic neuroendocrine tumors
Japan |
Pancreatic neuroendocrine tumor
Hepato-biliary-pancreatic medicine |
Others
NO
To evaluate the safety and efficacy of EUS-guided ethanol ablation therapy for pancreatic neuroendocrine tumors
Safety,Efficacy
Complete ablation rate
(Treatment responses were assessed according to enhanced residual tumor areas on CE-CT)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Maneuver |
Ethanol injection into the tumor by using EUS
20 | years-old | <= |
Not applicable |
Male and Female
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
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
5
1st name | |
Middle name | |
Last name | Hironari Kato |
Okayama University Hospital
Department of Gastroenterology & Hepatology
2-5-1 Shikata-cho,Kita-ku Okayama-city Okayama
086-235-7219
drkatocha@yahoo.co.jp
1st name | |
Middle name | |
Last name | Kazuyuki Matsumoto |
Okayama University Hospital
Department of Gastroenterology & Hepatology
2-5-1 Shikata-cho,Kita-ku Okayama-city Okayama
086-235-7219
matsumotokazuyuki0227@yahoo.co.jp
Okayama University Hospital
none
Self funding
NO
2015 | Year | 10 | Month | 31 | Day |
www.lib.okayama-u.ac.jp/www/acta/pdf/70_4_313.pdf
Unpublished
5
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.
2019 | Year | 03 | Month | 14 | Day |
No adverse event
Complete ablation at 1 month was achieved in 4 of the 5 tumors (80%).
Completed
2015 | Year | 10 | Month | 27 | Day |
2015 | Year | 10 | Month | 20 | Day |
2015 | Year | 10 | Month | 31 | Day |
2019 | Year | 03 | Month | 14 | Day |
2019 | Year | 03 | Month | 14 | Day |
2019 | Year | 03 | Month | 14 | Day |
2019 | Year | 03 | Month | 15 | Day |
2015 | Year | 08 | Month | 27 | Day |
2019 | Year | 03 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021786
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