Unique ID issued by UMIN | UMIN000031208 |
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Receipt number | R000035637 |
Scientific Title | Phase I/II trial of preoperative hepatic vein embolization to increase future remnant liver volume before hepatectomy. |
Date of disclosure of the study information | 2018/02/15 |
Last modified on | 2024/01/19 12:44:15 |
Phase I/II trial of preoperative hepatic vein embolization to increase future remnant liver volume before hepatectomy.
Phase I/II trial of hepatic vein embolization to increase future remnant liver volume.
Phase I/II trial of preoperative hepatic vein embolization to increase future remnant liver volume before hepatectomy.
Phase I/II trial of hepatic vein embolization to increase future remnant liver volume.
Japan |
Malignant hepatobiliary tumor
Hepato-biliary-pancreatic surgery |
Malignancy
NO
To evaluate the safety of hepatic vein embolization (HVE) combined with preoperative PTPE and clinical usefulness of whether future liver remnant volume increase can be obtained by HVE.
Safety,Efficacy
Proportion of complications after hepatic vein embolization(Phase I).
Future liver remnant volume after hepatic vein embolization, and functional remnant liver volume(Phase II).
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Maneuver |
hepatic vein embolization
20 | years-old | <= |
Not applicable |
Male and Female
1) Patients scheduled for hepatectomy in cases suspected of malignant tumor since January 2018
2) Patients over 20 years old
3) Patients for whom consent is documented for participation in this study
4) Patients who determined that the remnant liver volume is not sufficient after hepatectomy
5) Patients who underwent portal vein embolization
1) Patients whose liver function and general condition deteriorated after portal vein embolization (PTPE), and hepatic vein embolization was considered difficult to perform
2) Other patients judged unsuitable as subjects by doctor's judgment
21
1st name | Ken |
Middle name | |
Last name | Shirabe |
Gunma University Hospital
Department of Hepatobiliary and Pancreatic Surgery, Integrative center of general surgery
371-8511
3-39-15 Showa-machi, Maebashi, Gunma 371-8511, JAPAN
027-220-8227
kshirabe@gunma-u.ac.jp
1st name | Kenichiro |
Middle name | |
Last name | Araki |
Gunma University Hospital
Department of Hepatobiliary and Pancreatic Surgery, Integrative center of general surgery
371-8511
3-39-15 Showa-machi, Maebashi, Gunma 371-8511, JAPAN
027-220-8227
karaki@gunma-u.ac.jp
Department of Hepatobiliary and Pancreatic Surgery, Integrative center of general surgery, Gunma University
Department of Hepatobiliary and Pancreatic Surgery, Integrative center of general surgery, Gunma University
Self funding
Gunma University Hospital Clinical Research Review Board
3-39-15 Showa-machi, Maebashi city, GUNMA
027-220-7111
irb-jimukk-ciru@ml.gunma-u.ac.jp
NO
2018 | Year | 02 | Month | 15 | Day |
Partially published
12 patients were registered.
The results of the Phase I/II study were reported in a article as shown below.
J Hepatobiliary Pancreat Sci. 2023 Jan;30(1):91-101.
doi: 10.1002/jhbp.1207. Epub 2022 Jul 6.
First published: 23 June 2022
https://doi.org/10.1002/jhbp.1207
2024 | Year | 01 | Month | 19 | Day |
2022 | Year | 07 | Month | 23 | Day |
Open public recruiting
2017 | Year | 12 | Month | 27 | Day |
2017 | Year | 12 | Month | 28 | Day |
2018 | Year | 01 | Month | 04 | Day |
2027 | Year | 12 | Month | 31 | Day |
2018 | Year | 02 | Month | 08 | Day |
2024 | Year | 01 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035637
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