Quality Control Study of Laparoscopic Sentinel Node Biopsy in Early Gastric Cancer

National Cancer Center (NCC)

Status: Completed

Conditions: Early Gastric Cancer

Treatments: Procedure: Laparoscopic sentinel lymph node biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT01544413

SENORITA-2012

Details and patient eligibility

About

Laparoscopic sentinel lymph node biopsy and stomach preserving surgery in ealry gastric cancer is less invasive method which can increase quality of life. Multicenter phase III trial is requred to validate this method. In this study all items which are necessary for laparoscopic sentinel lymph node biopsy are identified according to checklist and evaluated the performance completement.

Enrollment: 112 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• gastric adenocarcinoma in preoperative endoscopic biopsy
• clinical stage T1-2N0
• long diameter of tumor <4cm
• distance between tumor and pylorus or cardia >2cm
• age: 20-80
• ECOG: 1 or 0
• patients will undergo laparoscopic gastrectomy

Exclusion criteria

• definite criteria of endoscopic submucosal dissection (size<2cm, differentiated type, no ulcer)
• no indication for surgery for cardiovascular, pulmonary disease
• pregancy
• drug allergy or previous abdominal surgery, radiotherpy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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112 participants in 1 patient group

Laparoscopic sentinel lymph node biopsy

Experimental group

Description:

This is a single armed study. After endoscopic marking using Tc99m HSA and indocyanine green fluid, Laparoscopic sentinel lymph node biopsy was performed and evalute at backtable.

Treatment:

Procedure: Laparoscopic sentinel lymph node biopsy