Unique ID issued by UMIN | UMIN000044973 |
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Receipt number | R000051386 |
Scientific Title | A single-center prospective study on the safety of endobiliary radiofrequency ablation of hilar malignant biliary stenosis |
Date of disclosure of the study information | 2021/07/27 |
Last modified on | 2021/07/27 21:22:07 |
A single-center prospective study on the safety of endobiliary radiofrequency ablation of hilar malignant biliary stenosis
Safety of endobiliary RFA for hilar malignant biliary stenosis
A single-center prospective study on the safety of endobiliary radiofrequency ablation of hilar malignant biliary stenosis
Safety of endobiliary RFA for hilar malignant biliary stenosis
Japan |
hilar malignant biliary stenosis
Hepato-biliary-pancreatic medicine |
Malignancy
NO
To verify the safety of endoscopic radiofrequency ablation of hilar malignant biliary stenosis.
Safety
Adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment | Maneuver |
endobiliary radiofrequency ablation
20 | years-old | <= |
Not applicable |
Male and Female
1. Unresectable malignant hilar biliary obstruction with pathological proof
2.Bismuth classification 2,3,4
3.ECOG performance status 0-3
4.Given written informed consent
1.Patients in whom the endoscope cannot reach the duodenal papilla
2.Patients with jaundice or cholangitis that cannot be controlled by biliary drainage
3.Patients with serious complications in other organs: ASA classification of 3 or higher
4.Patients with a life expectancy of less than 3 months
5.Patients with a history of surgical gastrointestinal reconstruction
6.Patients with significant invasion of the hepatic artery by the tumor
7.Patients who are deemed inappropriate by the researcher
20
1st name | Arata |
Middle name | |
Last name | Sakai |
Kobe University Hospital
Division of gastroenterology, Department of Internal medicine
6500017
7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
+81-78-382-5774
asakai@med.kobe-u.ac.jp
1st name | Arata |
Middle name | |
Last name | Sakai |
Kobe University Hospital
Division of gastroenterology, Department of Internal medicine
650-0017
7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
+81-78-382-5774
asakai@med.kobe-u.ac.jp
Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate school of Medicine
Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate school of Medicine
Other
kobe University IRB office
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
078-382-6669
kainyu@med.kobe-u.ac.jp
NO
2021 | Year | 07 | Month | 27 | Day |
Unpublished
Preinitiation
2021 | Year | 07 | Month | 27 | Day |
2021 | Year | 09 | Month | 01 | Day |
2023 | Year | 08 | Month | 31 | Day |
2021 | Year | 07 | Month | 27 | Day |
2021 | Year | 07 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051386
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