Unique ID issued by UMIN | C000000059 |
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Receipt number | R000000104 |
Scientific Title | Evaluation of feasibility and accuracy of diagnosis using sentinel node biopsy in early gastric cancer(JCOG0302, GCSSG-SNB) |
Date of disclosure of the study information | 2005/08/15 |
Last modified on | 2014/02/21 13:54:42 |
Evaluation of feasibility and accuracy of diagnosis using sentinel node biopsy in early gastric cancer(JCOG0302, GCSSG-SNB)
Evaluation of feasibility and accuracy of diagnosis using sentinel node biopsy in early gastric cancer(JCOG0302, GCSSG-SNB)
Evaluation of feasibility and accuracy of diagnosis using sentinel node biopsy in early gastric cancer(JCOG0302, GCSSG-SNB)
Evaluation of feasibility and accuracy of diagnosis using sentinel node biopsy in early gastric cancer(JCOG0302, GCSSG-SNB)
Japan |
gastric neoplasm
Gastrointestinal surgery |
Malignancy
NO
To evaluate feasibility and accuracy of diagnosis using sentinel node biopsy in early gastric cancer.
Efficacy
Exploratory
Phase II
False-negative rate
Success rate, false-positive rate, post-operative morbidity, anaphylaxis reaction, relapse-free survival of patients with lymph node metastases
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Diagnosis
Maneuver |
Gastrectomy with extemded lymphadenectomy after sentinel node biopsy
20 | years-old | <= |
80 | years-old | >= |
Male and Female
Preoperatively,
(1) histologically proven adenocarcinoma,
(2)T1, and 4cm or less in diameter, no tumor within 2cm from esophagogastric junction or pyloric ring,
(3) no existence of multiple foci,
(4) no prior treatment for gastric cancer,
(5) no prior surgery for gastric or duodenal ulcer
(6) written informed consent.
Intra-operatively,
(7) prior to dye injection,
(8) not laparoscopic surgery,
(9) T1,
(10) palpable of tumor or marking clips,
(11) no apparent lymph node metastasis,
(12) no severe adhesion around stomach.
(1) anaphylaxis reaction against iodine,
(2) non-curative synchronous malignancy.
1550
1st name | |
Middle name | |
Last name | Masahiro Hiratsuka, MD, PhD |
Itami municipal hospital
Surgery
1-100 Koyaike, Itami, Hyogo 664-8540, JAPAN
1st name | |
Middle name | |
Last name | Isao Miyashiro, MD, PhD |
JCOG0302 Coordinating Office
Gastric Surgery Division, Osaka Medical Center for Cancer and Cardiovascular Diseases
1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, JAPAN
http://www.jcog.jp/
JCOG_sir@ml.jcog.jp
Japan Clinical Oncology Group(JCOG)
Ministry of Health, Labour and Welfare
Japan
NO
岩手医科大学(岩手県)
国立病院機構仙台医療センター(宮城県)
宮城県立がんセンター(宮城県)
山形県立中央病院(山形県)
防衛医科大学校(埼玉県)
埼玉県立がんセンター(埼玉県)
国立がんセンター東病院(千葉県)
国立がんセンター中央病院(東京都)
都立駒込病院(東京都)
都立墨東病院(東京都)
神奈川県立がんセンター(神奈川県)
新潟県立がんセンター新潟病院(新潟県)
新潟県厚生連長岡中央綜合病院(新潟県)
燕労災病院(新潟県)
富山県立中央病院(富山県)
岐阜市民病院(岐阜県)
愛知県がんセンター中央病院 (愛知県)
京都第2赤十字病院(京都府)
近畿大学医学部(大阪府)
大阪府立病院機構大阪府立成人病センター(大阪府)
国立病院機構大阪医療センター(大阪府)
大阪医科大学(大阪府)
市立豊中病院(大阪府)
市立堺病院(大阪府)
市立伊丹病院(兵庫県)
和歌山県立医科大学(和歌山県)
広島市立広島市民病院(広島県)
国立病院機構四国がんセンター(愛媛県)
2005 | Year | 08 | Month | 15 | Day |
Published
http://www.ncbi.nlm.nih.gov/pubmed/23933782
See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website:
http://www.jcog.jp/en/trials/index.html
Terminated
2004 | Year | 01 | Month | 13 | Day |
2004 | Year | 05 | Month | 01 | Day |
2012 | Year | 11 | Month | 01 | Day |
2005 | Year | 08 | Month | 15 | Day |
2014 | Year | 02 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000104
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