Unique ID issued by UMIN | UMIN000003213 |
---|---|
Receipt number | R000003896 |
Scientific Title | Standardization of the extent of resection in nonradical neck dissections |
Date of disclosure of the study information | 2010/02/23 |
Last modified on | 2010/02/19 16:51:05 |
Standardization of the extent of resection in nonradical neck dissections
Standardization of neck dissection
Standardization of the extent of resection in nonradical neck dissections
Standardization of neck dissection
Japan |
Head and neck cancer
Surgery in general | Oto-rhino-laryngology |
Malignancy
NO
To standardize neck dissection procedures so that head and neck cancer patients treated in 22 participating hospitals will undergo the same neck dissection procedure regarding the extent of resection of the neck lymph nodes and non-lymphatic structures if the primary site and stage are the same.
Others
To explore the feasibility and effects of standardization of neck dissection procedures.
Exploratory
Pragmatic
Phase II
2-year neck control rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Maneuver |
Neck dissection, in which a surgeon of another hospital observes the procedure directly and records its details according to a specialized form.
Not applicable |
Not applicable |
Male and Female
1) Patients who have submitted written informed consent
2) Patients with head and neck cancer
3) Previously untreated patients who undergo neck dissection during the first treatment
1) Patients with recurrent cancer
2) Patients with cancer of unknown primary site
3) Patients considered as inappropriate by their doctors
235
1st name | |
Middle name | |
Last name | Masahisa Saikawa |
National Cancer Center Hospital East
Division of Head and Neck Surgery
6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, JAPAN
04-7133-1111
1st name | |
Middle name | |
Last name | Masahisa Saikawa |
National Cancer Center Hospital East
Division of Head and Neck Surgery
6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, JAPAN
04-7133-1111
mhsaikaw@east.ncc.go.jp
The Japan Neck Dissection Study Group (JNDSG)
Ministry of Health, Labour and Welfare, JAPAN
JAPAN
none
none
NO
1. 国立がんセンター東病院(千葉県) National Cancer Center Hospital East, Chiba
2. 国立がんセンター中央病院(東京都) National Cancer Center Hospital, Tokyo
3. 宮城県立がんセンター(宮城県) Miyagi Cancer Center, Miyagi
4. 群馬県立がんセンター(群馬県) Gunma Cancer Center, Gunma
5. 埼玉県立がんセンター(埼玉県) Saitama Cancer Center, Saitama
6. 埼玉医科大学国際医療センター(埼玉県) Saitama Medical School, Saitama
7. 千葉県がんセンター(千葉県) Chiba Cancer Center Hospital, Chiba
8. 東京医科歯科大学医学部附属病院(東京都) Tokyo Medical and Dental University, Tokyo
9. 東京大学医学部附属病院(東京都) Graduate School of Medicine, University of Tokyo, Tokyo
10. 癌研有明病院(東京都) Cancer Institute Hospital, Tokyo
11. 国立病院機構東京医療センター(東京都) National Hospital Organization Tokyo Medical Center, Tokyo
12. 杏林大学医学部附属病院(東京都) Kyorin University School of Medicine, Tokyo
13. 神奈川県立がんセンター(神奈川県) Kanagawa Cancer Center, Kanagawa
14. 静岡県立静岡がんセンター(静岡県) Shizuoka Cancer Center, Shizuoka
15. 愛知県がんセンター中央病院(愛知県) Aichi Cancer Center Hospital, Aichi
16. 国立病院機構京都医療センター(京都府) National Hospital Organization Kyoto Medical Center, Kyoto
16. 大阪府立成人病センター(大阪府) Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka
18. 神戸大学医学部附属病院(兵庫県) Graduate School of Medicine, Kobe University, Hyogo
19. 国立病院機構四国がんセンター(愛媛県) National Hospital Organizationa Shikoku Cancer Center, Ehime
20. 高知大学医学部附属病院(高知県) Kochi Medical School, Kochi
21. 国立病院機構九州がんセンター(福岡県) National Kyushu Cancer Center, Fukuoka
22. 久留米大学病院(福岡県) Kurume University School of Medicine, Fukuoka
2010 | Year | 02 | Month | 23 | Day |
Published
http://springerlink.metapress.com/content/x5650u23026587v6/?p=3e53cc78c0544ddfb801780c82473fa4&pi=3
1. A total of 235 patients were enrolled between Feb. 18, 2004 and Nov. 22, 2006.
2. The follow-up of this study was completed on July 27, 2009. The percentage of patients with a follow-up less than 2 years was 2.3%.
3. Of the 79 questions of the observation form, difference among participating hospitals was confirmed in 13 details and strongly suspected in 7 details.
4. To standardize these 20 details, JNDSG established a manual, "Standard Surgical Maneuvers for Each Detail of Neck Dissection," based on the discussion about the optimal procedures concerning each detail.
5. As the study proceeded from the first to the second stage, the intensity of difference among the hospitals decreased in 11 details and increased in 6 details. Because there were more details showing decreased intensity, this study was concluded to have contributed to some extent to the standardization of nonradical neck dissections in Japan.
6. Although standardization of a surgical procedure in a multi-institutional setting is a very rare undertaking, this study achieved noteworthy success.
Completed
2003 | Year | 11 | Month | 27 | Day |
2004 | Year | 02 | Month | 01 | Day |
2009 | Year | 07 | Month | 01 | Day |
2009 | Year | 07 | Month | 01 | Day |
2009 | Year | 08 | Month | 01 | Day |
2009 | Year | 09 | Month | 01 | Day |
2010 | Year | 02 | Month | 19 | Day |
2010 | Year | 02 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003896
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