Unique ID issued by UMIN | UMIN000017395 |
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Receipt number | R000020178 |
Scientific Title | Trial of recurrent laryngeal nerve monitoring during radical esophagectomy for prevention of nerve palsy |
Date of disclosure of the study information | 2015/05/02 |
Last modified on | 2020/11/04 09:11:42 |
Trial of recurrent laryngeal nerve monitoring during radical esophagectomy for prevention of nerve palsy
Trial of recurrent laryngeal nerve monitoring during radical esophagectomy for prevention of nerve palsy
Trial of recurrent laryngeal nerve monitoring during radical esophagectomy for prevention of nerve palsy
Trial of recurrent laryngeal nerve monitoring during radical esophagectomy for prevention of nerve palsy
Japan |
Esophageal cancer
Gastrointestinal surgery |
Malignancy
NO
Prospective study of evaluation of preventive effects for recurrent laryngeal nerve palsy with electrical nerve monitoring during radical esophagectomy
Safety,Efficacy
Incidence of recrrent laryngeal nerve palsy after radical esophagectomy
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment | Maneuver |
Electrical recurrent laryngeal nerve monitoring during radical esophagectomy
20 | years-old | <= |
80 | years-old | >= |
Male and Female
Patient undergoing radical surgery for esphageal cancer meet following criteria:
1) Resectable disease
2) Clinical stage I, II or III excluding T4b disease (UICC tumor, node, metastasis system TNM classification)
3) Age 20 to 80 years
4) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
5) No previous surgery for esophageal cancers
6) No previous chemo- or radiotherapy for any malignancies
7) Sufficient organ function
8) Written informed consent
1) Other primary cancer
2) Psychiatric disease
3) Serious complications
4) Cardiovascular disease or heart failure occur within 3 months
5) Cerebrovascular disease occur within 3 months
6) Active infection
7) With cardiac pacemaker or defibrillator
8) Positive for hepatitis B virus antigen
9) Pregnancy
10) Others who are inadequate to entry this study
80
1st name | Makoto |
Middle name | |
Last name | Hikage |
Tohoku University Hospital
Department of Advanced Surgical Science and Technology
980-8574
Seiryo-machi 1-1, Aoba-ku, Sendai 980-8574, Japan
022-717-7214
mhikage@med.tohoku.ac.jp
1st name | Makoto |
Middle name | |
Last name | Hikage |
Tohoku University Hospital
Department of Advanced Surgical Science and Technology
980-8574
Seiryo-machi 1-1, Aoba-ku, Sendai 980-8574, Japan
022-717-7214
mhikage@med.tohoku.ac.jp
Tohoku University Hospital
JSPS
Japanese Governmental office
Institutional Review Board of Tohoku University Hospital
Seiryo-machi 1-1, Aoba-ku, Sendai 980-8574, Japan
022-728-4105
rinri-2@proj.med.tohoku.ac.jp
NO
東北大学病院(宮城県)
2015 | Year | 05 | Month | 02 | Day |
Unpublished
Main results already published
2014 | Year | 02 | Month | 18 | Day |
2014 | Year | 02 | Month | 18 | Day |
2014 | Year | 03 | Month | 01 | Day |
2019 | Year | 03 | Month | 31 | Day |
2015 | Year | 05 | Month | 02 | Day |
2020 | Year | 11 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020178
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