A phase III study of Sentinel Node Navigation Surgery for Early Gastric Cancer

JRCT ID: jRCTs031180432

Registered date:27/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Clinically diagnosed T1N0 early gastric cancer
• Date of first enrollment: 07/07/2014
• Target sample size: 225
• Study type: Interventional

Intervention(s)

Minimized gastrectomy and sentinel basin resection group is for the patients whose sentinel nodes were negative by intraoperative pathological diagnosis and spread within the confines of the resection range of minimized surgery.
Conventional gastrectomy and sentinel basin resection group is for the patients whose sentinel nodes were negative by intraoperative pathological diagnosis and spread beyond the confines of the resection range of minimized surgery.
Conventional gastrectomy group is for the patients whose sentinel nodes were positive by intraoperative pathological diagnosis.

Outcome(s)

• Primary Outcome: Postoperative 5-year recurrence free survival(RFS) ratio
• Secondary Outcome: 5-year recurrence-free survival rate for PPS, postoperative 3-year RFS rate, postoperative 3/5-year overall survival, sentinel node detection rate, distribution, sensitivity, accuracy for lymph node metastases, quality of life after surgery

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Aged over 20 years old and ECOG performance status of 0 or 1
2) Clinically diagnosed T1N0M0 early gastric cancer
3) Single lesion
4) Less than 40mm in size
5) Provided written informed consent
6) The histological classification of the biopsy tisuue is as a general type of malignant epitherial tumor or carcinoma with lymphoid stroma

Exclude criteria

1) Patients pregnancy, allergic to drug such as 99m Tc tin colloid, indigo carmine and indocyanine green
2) Tumors are located in cardia or pyloric ring
3) Synchronous or metachronous (within 5 years) malignancies.
4) With prior treatment to same lesion
5) Remnant gastric cancer
6) Absolute indication for endoscopic treatments
7) Judged as irrelevant object for this study
8) Refusal of the trial entry

Related Information

• Primary Sponsor: Kitagawa Yuko
• Secondary Sponsor: Kawakubo Hirofumi
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development
• Secondary ID(s): UMIN000014401