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

Overview

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.

Full Title of Study: “Prospective Multicenter Study on Laparoscopic Gastric Cancer Surgery Compared With Open Surgery for Locally Advanced Gastric Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2018

Interventions

  • Procedure: Laparoscopic procedures
    • Laparoscopic surgery
  • Procedure: Open Surgery
    • Open surgery

Arms, Groups and Cohorts

  • Experimental: Laparoscopic surgery
    • Traditional open procedure for patient with locally advanced gastric cancer
  • Active Comparator: Open surgery
    • Minimum invasive procedure (laparoscopic) for patient with locally advanced gastric cancer

Clinical Trial Outcome Measures

Primary Measures

  • “Major” Surgical Morbidity
    • Time Frame: 21 days.
    • “Major” Surgical morbidity is defined as the complication grade on III-V Clavien-Dindo Classification which occurs with-in postoperative 21 days, extension of hospitalization and re-hospitalization. It is necessary to evaluate the complication and if it occurs during the hospitalization, it is required to record complication name, date of on-set (postoperatively), grade on Clavien-Dindo Classification and treatment for complication.

Secondary Measures

  • 3-year progression-free survival
    • Time Frame: 36 months
    • In terms of locally advanced gastric cancer, to evaluate the progression-free survival rate in laparoscopic gastrectomy with D2 lymph node dissection at postoperative 3 years compared with open procedures
  • 3-year overall survival
    • Time Frame: 6, 12, 18, 24, 30 and 36 months
    • In terms of locally advanced gastric cancer, to evaluate the overall survival rate in laparoscopic gastrectomy with D2 lymph node dissection at postoperative 3 years compared with open procedures
  • 5-year overall survival rate
    • Time Frame: 6, 12, 18, 24, 30, 36, 48 and 60 months
    • In terms of locally advanced gastric cancer, to evaluate the overall survival rate in laparoscopic gastrectomy with D2 lymph node dissection at postoperative 5 years compared with open procedures
  • Surgical Mortality
    • Time Frame: 90 days
    • It is defined as the death within postoperative 90 days regardless of postoperative reason.
  • Peri-operative blood loss
    • Time Frame: 1 day
    • Minimally-invasive surgery is associated with less peri-operative blood loss. Blood loss will be measured in milliliters and average blood loss will be compared to the conventional ‘open’ group.
  • Postoperative recovery index
    • Time Frame: 10 days
    • Time to first ambulation, flatus, liquid diet, soft diet, and duration of hospital stay are used to assess the postoperative recovery course The amount of abdominal drainage and blood transfusion are also recorded
  • Pain scores
    • Time Frame: up to 3 days after surgery
    • Pain scores based on a visual analog scale the day of surgery and the subsequent 3 days postoperative 1 days, 2 days, 3 days
  • Postoperative quality of life
    • Time Frame: 6, 12, 18, 24, 30 and 36 months
    • Both the European Organization for Research and Treatment of Cancer (EORTC) C30 and STO22 are analyzed with quality of life
  • long-term surgical morbidity
    • Time Frame: 21days – 36 months after surgery
    • Surgical morbidity is defined as the events which occurs with-in postoperative 21 days – 36 months after surgery. It is necessary to evaluate the complication, it is required to record complication name, date of on-set. Long complications are included: hernia, bleeding, bowel obstruction etc.
  • Extent of lymph node dissection
    • Time Frame: 2 weeks
    • The extent of lymph node dissection in treatment of gastric cancer is considered a prognostic marker for postoperative survival and disease-free survival. Before implementation of a new surgical technique, it is imperative that this technique is non-inferior with regard to the extent of lymph node dissection. Measures will include the number of resected lymph nodes and the number of resected lymph node stations.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 82 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Moscow Clinical Scientific Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Michail Byachov, MD, PhD, Study Chair, Moscow Clinical Scientific Center
    • Roman Izrailov, MD, PhD, Study Chair, Moscow Clinical Scientific Center
    • Boris Pomortsev, MD, Principal Investigator, Moscow Clinical Scientific Center
    • Pavel Kononets, MD, PhD, Principal Investigator, Moscow Oncological Hospital 62
    • Andrey Ryabov, MD, PhD, Principal Investigator, P.Herzen Moscow Oncological Research Institute
    • Vladimir Lyadov, MD, PhD, Principal Investigator, Treatment and Rehabilitation Centre of Health Ministry of Russia
    • Alexey Karachun, MD, PhD, Principal Investigator, N. Petrov National Research Institute of Oncology
    • Victor Kashchenko, MD, PhD, Principal Investigator, Federal Medical Biology Agence №122 the name of L.Sokolov
    • Andrey Pavlenko, MD, PhD, Principal Investigator, Leningradsky oncological center
    • Michail Lando, MD, PhD, Principal Investigator, Lipetsk regional oncological center
    • Sergey Baydo, MD, PhD, Principal Investigator, Lisod clinic Kiev
    • Igor Khatkov, MD, PhD, Study Director, Moscow Clinical Scientific Center
    • Michail Prostov, Principal Investigator, Moscow Clinical Scientific Center
    • Kirill Schostka, MD, PhD, Principal Investigator, Leningradsky oncological center
  • Overall Contact(s)
    • Igor Khathov, MD, PhD, 8 (495) 3042908, ihatkov@gmail.com

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