Unique ID issued by UMIN | UMIN000010458 |
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Receipt number | R000012222 |
Scientific Title | Feasibility of sentinel node mapping as the index of metastasis in early gastric cancer following endoscopic resection: A phase II trial |
Date of disclosure of the study information | 2013/04/10 |
Last modified on | 2020/05/08 08:44:03 |
Feasibility of sentinel node mapping as the index of metastasis in early gastric cancer following endoscopic resection: A phase II trial
Feasibility of sentinel node as the index of metastasis in early gastric cancer following endoscopic resection: A phase II trial
Feasibility of sentinel node mapping as the index of metastasis in early gastric cancer following endoscopic resection: A phase II trial
Feasibility of sentinel node as the index of metastasis in early gastric cancer following endoscopic resection: A phase II trial
Japan |
Gastric cancer following endoscopic resection
Gastrointestinal surgery |
Malignancy
NO
To assess the availability and safety of the gastrectomy with sentinel node mapping for early gastric cancer following endoscopic resection
Safety,Efficacy
Exploratory
Explanatory
Phase II
Diagnostic accuracy for lymph node metastases
Detection rate
Distribution
Sensitivity
Adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine | Device,equipment |
Gastrectomy and lymphadenectomy according to the Japanese guideline with dual tracer method using a radioactive colloid and blue dye
20 | years-old | <= |
80 | years-old | >= |
Male and Female
Patients with a single tumor <4cm in diameter required additional surgery following endoscopic resection.
1) Pathological T1a (M), differentiated-type adenocarcinoma with ulceration, 3 cm<
2) pT1a (M), undifferentiated-type without ulceration, 2cm<
3) pT1a (M), undifferentiated-type with ulceration
4) pT1b (SM1) differentiated-type without ulceration, 3cm<
5) pT1b (SM1) with ulceration
6) pT1b (SM2/3)
7) vascular invasion positive
8) resection margin positive
Within 3 months from endoscopic resection to surgery
Written informed consent
Pregnancy
Past history of severe drug allergy
Asthma
Active other primary malignancies
Patients whom doctors judged inadequate to the enrollment of this study by other reasons
Gastric remnant cancer
60
1st name | |
Middle name | |
Last name | Yuko Kitagawa |
School of Medicine, Keio University
Department of Surgery
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
03-5363-3802
kitagawa@a3.keio.jp
1st name | |
Middle name | |
Last name | Hiroya Takeuchi |
School of Medicine, Keio University
Department of Surgery
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
03-5363-3802
htakeuchi@a6.keio.jp
Japanese Society for sentinel node navigation surgery
None
Self funding
NO
2013 | Year | 04 | Month | 10 | Day |
Unpublished
Terminated
2012 | Year | 11 | Month | 02 | Day |
2013 | Year | 03 | Month | 19 | Day |
2013 | Year | 05 | Month | 01 | Day |
2015 | Year | 10 | Month | 22 | Day |
2013 | Year | 04 | Month | 09 | Day |
2020 | Year | 05 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012222
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