A Phase II Clinical Trial of Reduced Port Totally Laparoscopic Distal Gastrectomy With D2 Lymph Node Dissection

Samsung Medical Center

Status and phase: Unknown; Phase 2

Conditions: Gastric Cancer

Treatments: Procedure: reduced port laparoscopic distal gastrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02311595

2014-10-032

Details and patient eligibility

About

The purpose of this study is to determine if reduced port totally laparoscopic distal gastrectomy with complete D2 lymph node dissection for gastric cancer is safe and oncological feasible.

67 patients with gastric cancer with preoperative staging from T1 to T3 will undergo reduced port totally laparoscopic distal gastrectomy.

The primary end point of this study is to measure compliance rate with pathology report and compare with previous compliance rate data.

Enrollment: 67 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histologically confirmed adenocarcinoma of the stomach
• Eastern Cooperative Oncology Group Eastern Cooperative Oncology Group performance status 0-1,
• signed informed consent
• location of the primary tumor in the antrum, angle and lower body
• no evidence of distant metastasis or invasion to adjacent organs or serosal infiltration

Exclusion criteria

• metastatic disease
• previous history of malignancy in any organ
• any co-morbidity obviating major surgery

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

67 participants in 1 patient group

reduced port

Experimental group

Description:

gastric cancer patients go through reduced port laparoscopic distal gastrectomy with D2 lymph node dissection

Treatment:

Procedure: reduced port laparoscopic distal gastrectomy