A Comparison Laparoscopic With Open Gastric Cancer Surgery for Locally Advanced Gastric Cancer

Moscow Clinical Scientific Center

Status and phase: Unknown; Phase 3

Conditions: Gastric Cancer

Treatments: Procedure: Open Surgery; Procedure: Laparoscopic procedures

Study type: Interventional

Funder types: Other

Identifiers

NCT02748551

MKNC 01/2016

Details and patient eligibility

About

Nowadays, the proportion of patients with locally advanced gastric cancer is estimated up to 90 percent of all gastric cancer cases in Russian Federation. Surgical procedure with D2 Lymphadenectomy is the main option for treatment. Conventional open approach is still the current standard for advanced gastric cancer. Laparoscopic procedures for gastric cancer as minimally invasive surgery has gained popularity for the treatment of early gastric cancer in East Asia. Several studies indicated that laparoscopic procedures both total and subtotal gastrectomy with D2 lymphadenectomy is a technically feasible and safe procedure by experienced surgeons in high-volume specialized hospitals. However, lack of solid evidence on the oncologic efficacy.

Starting clinical trials for evaluate safety of oncology laparoscopic subtotal gastrectomy for locally advanced gastric cancer. Aim of this trial is show safety, feasibility and oncologic efficacy of Laparoscopic radical surgical procedures both total and subtotal gastrectomy for treatment gastric cancer.

Enrollment: 800 estimated patients

Sex: All

Ages: 18 to 82 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ECOG 0-1
• ASA I-III
• Histologically proven cancer of the stomach cT 2-4a(clinical stage tumor), N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
• Preoperative examination with no distant metastasis, no significantly enlarged lymph nodes around abdominal main artery, and tumor not a direct violation of the pancreas, spleen and other surrounding organs
• The gastric tumors are located in the stomach, are macroscopically resectable by subtotal or total gastrectomy with D2 lymph node dissection.
• Written informed consent

Exclusion criteria

• Clinically apparent distant metastasis
• Free cancer cells
• Bulky lymph node metastasis is detected by abdominal CT
• Previous treatment with radiation therapy for any tumors.
• Previous surgery for the present disease
• Pregnancy
• Psychiatric disease

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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800 participants in 2 patient groups

Laparoscopic surgery

Experimental group

Description:

Traditional open procedure for patient with locally advanced gastric cancer

Treatment:

Procedure: Open Surgery

Open surgery

Active Comparator group

Description:

Minimum invasive procedure (laparoscopic) for patient with locally advanced gastric cancer

Treatment:

Procedure: Laparoscopic procedures