Unique ID issued by UMIN | UMIN000029317 |
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Receipt number | R000033516 |
Scientific Title | Single-arm feasibility study of laparoscopic distal gastrectomy for advanced gastric cancer to verify the safety of proximal margins |
Date of disclosure of the study information | 2017/10/01 |
Last modified on | 2023/09/18 10:34:11 |
Single-arm feasibility study of laparoscopic distal gastrectomy for advanced gastric cancer to verify the safety of proximal margins
Single-arm feasibility study of laparoscopic distal gastrectomy for advanced gastric cancer to verify the safety of proximal margins
Single-arm feasibility study of laparoscopic distal gastrectomy for advanced gastric cancer to verify the safety of proximal margins
Single-arm feasibility study of laparoscopic distal gastrectomy for advanced gastric cancer to verify the safety of proximal margins
Japan |
Gastric cancer
Gastrointestinal surgery |
Malignancy
NO
To confirm the equality in terms of proximal margins in laparoscopic distal gastrectomy against open distal gastrectomy.
Safety
Proximal margins
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Maneuver |
Perform laparoscopic distal gastrectomy for patients diagnosed as cT1N2-3, cT2N0-3, cT3N0, or cT4aN0 gastric cancer.
20 | years-old | <= |
Not applicable |
Male and Female
1) The cancer is histologically proven adenocarcinoma of the stomach.
2) The cancer has been diagnosed as clinical T1N2-3, T2N0-3, T3N0, T4aN0, and cM0 with no bulky metastatic lymph nodes.
3) The patient is 20 years of age or older.
4) The patient has an Eastern Cooperative Oncology Group performance status of 0 to 2.
5) The patient has no history of treatment for gastric cancer.
6) The patient has a body mass index of less than 35 kg/m2.
7) Written informed consent is provided.
1) Patients with synchronous double cancer, metachronous double cancer (within 5 years) (except carcinoma in situ).
2) Patients with cT4b, cM1 gastric cancer
3) Patients who went under preoperative treatment for gastric cancer (except staging laparoscopy).
4) Patients with possibility of pregnancy.
5) Patients with mental disorder who are difficult to participate in the study.
6) Patients who are recieving steroid therapy.
7) Patients with viral, bacterial, and fungal infections who requires medical treatment.
8) Patients with poorly controlled diabetes.
9) Patients with unstable angina or myocardial infarction
10) Patients with respiratory disorder who requires oxygen inhalation.
130
1st name | Souya |
Middle name | |
Last name | Nunobe |
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Department Gastroenterological Surgery
135-8550
3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan
03-3520-0111
souya.nunobe@jfcr.or.jp
1st name | Rie |
Middle name | |
Last name | Makuuchi |
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Department Gastroenterological Surgery
135-8550
3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan
03-3520-0111
rie.makuuchi@jfcr.or.jp
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Non profit foundation
Cancer Institute Hospital, Japanese Foundation for Cancer Research
3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan
03-3570-0210
med.shinsa@jfcr.or.jp
YES
2017-1049
Cancer Institute Hospital, Japanese Foundation for Cancer Research
2017 | Year | 10 | Month | 01 | Day |
Unpublished
No longer recruiting
2017 | Year | 09 | Month | 25 | Day |
2017 | Year | 09 | Month | 27 | Day |
2017 | Year | 10 | Month | 01 | Day |
2027 | Year | 09 | Month | 30 | Day |
2017 | Year | 09 | Month | 27 | Day |
2023 | Year | 09 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033516
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