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

Summary

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.

Conditions

• Gastric Cancer

Interventions

PROCEDURE

Laparoscopic procedures

Laparoscopic surgery

PROCEDURE

Open Surgery

Open surgery

Sponsors & Collaborators

• Moscow Clinical Scientific Center

  lead OTHER

Principal Investigators

• Michail Byachov, MD, PhD · Moscow Clinical Scientific Center

• Roman Izrailov, MD, PhD · Moscow Clinical Scientific Center

• Boris Pomortsev, MD · Moscow Clinical Scientific Center

• Pavel Kononets, MD, PhD · Moscow Oncological Hospital 62

• Andrey Ryabov, MD, PhD · P.Herzen Moscow Oncological Research Institute

• Vladimir Lyadov, MD, PhD · Treatment and Rehabilitation Centre of Health Ministry of Russia

• Alexey Karachun, MD, PhD · N. Petrov National Research Institute of Oncology

• Victor Kashchenko, MD, PhD · Federal Medical Biology Agence №122 the name of L.Sokolov

• Andrey Pavlenko, MD, PhD · Leningradsky oncological center

• Michail Lando, MD, PhD · Lipetsk regional oncological center

• Sergey Baydo, MD, PhD · Lisod clinic Kiev

• Igor Khatkov, MD, PhD · Moscow Clinical Scientific Center

• Michail Prostov · Moscow Clinical Scientific Center

• Kirill Schostka, MD, PhD · Leningradsky oncological center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

82 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-04-30

Primary Completion

2018-04-30

Completion

2022-04-30

Countries

• Russia
• Ukraine

Study Locations