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

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Multicenter Study on Laparoscopic Gastric Cancer Surgery Compared With Open Surgery for Locally Advanced Gastric Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
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* Procedure: Laparoscopic procedures
* Procedure: Open Surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 82 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic surgery<br>Traditional open procedure for patient with locally advanced gastric cancer | Procedure: Open Surgery<br>* Open surgery<br>|
| Active Comparator: Open surgery<br>Minimum invasive procedure (laparoscopic) for patient with locally advanced gastric cancer | Procedure: Laparoscopic procedures<br>* Laparoscopic surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Surgical Morbidity | 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. | 21 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year progression-free survival | 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 | 36 months | 
| 3-year overall survival | 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 | 6, 12, 18, 24, 30 and 36 months | 
| 5-year overall survival rate | 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 | 6, 12, 18, 24, 30, 36, 48 and 60 months | 
| Surgical Mortality | It is defined as the death within postoperative 90 days regardless of postoperative reason. | 90 days | 
| Peri-operative blood loss | 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. | 1 day | 
| Postoperative recovery index | 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 | 10 days | 
| Pain scores | Pain scores based on a visual analog scale the day of surgery and the subsequent 3 days postoperative 1 days, 2 days, 3 days | up to 3 days after surgery | 
| Postoperative quality of life | Both the European Organization for Research and Treatment of Cancer (EORTC) C30 and STO22 are analyzed with quality of life | 6, 12, 18, 24, 30 and 36 months | 
| long-term surgical morbidity | 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. | 21days - 36 months after surgery | 
| Extent of lymph node dissection | 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. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric cancer, locally advanced gastric cancer, laparoscopic surgery, laparoscopic procedure, comparison laparoscopic with open procedure, multicenter trials