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

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Disease Information

Descriptive Information
Brief Title † A Comparison Laparoscopic With Open Gastric Cancer Surgery for Locally Advanced Gastric Cancer
Official Title † Prospective Multicenter Study on Laparoscopic Gastric Cancer Surgery Compared With Open Surgery for Locally Advanced Gastric Cancer
Brief 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.
Detailed Description
Study Phase Phase 3
Study Type † Interventional
Study Design † Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure † "Major" Surgical Morbidity
Secondary Outcome Measure † 3-year progression-free survival
Condition † Gastric Cancer
Intervention † ProcedureLaparoscopic procedures
Study Arms / Comparison Groups Laparoscopic surgery Traditional open procedure for patient with locally advanced gastric cancer Open surgery Minimum invasive procedure (laparoscopic) for patient with locally advanced gastric cancer
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Procedure
Estimated Enrollment † 800
Start Date † April 2016
Completion Date April 2022
Primary Completion Date April 2018
Eligibility Criteria † 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 Both
Ages 18 Years - 82 Years
Accepts Healthy Volunteers No
Contacts †† Igor Khathov, MD, PhD, 8 (495) 3042908, ihatkov@gmail.com
Location Countries † Russian Federation
Administrative Information
NCT ID † NCT02748551
Organization ID MKNC 01/2016
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Moscow Clinical Scientific Center
Collaborators ††
Investigators † Study Chair: Michail Byachov, MD, PhD, Moscow Clinical Scientific Center
Information Provided By
Verification Date December 2016
First Received Date † April 10, 2016
Last Updated Date December 11, 2016
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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