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

M

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)

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

Trial contacts and locations

9

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Central trial contact

Igor Khathov, MD, PhD; Roman Izrailov, MD, PhD

Data sourced from clinicaltrials.gov

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