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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic surgery | Experimental | Traditional open procedure for patient with locally advanced gastric cancer |
|
| Open surgery | Active Comparator | Minimum invasive procedure (laparoscopic) for patient with locally advanced gastric cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic procedures | Procedure | Laparoscopic surgery |
| |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Igor Khathov, MD, PhD | Contact | 8 (495) 3042908 | ihatkov@gmail.com | |
| Roman Izrailov, MD, PhD | Contact | 8 (495) 3042908 | izrailev@mail.ru |
| Name | Affiliation | Role |
|---|---|---|
| Michail Byachov, MD, PhD | Moscow Clinical Scientific Center | Study Chair |
| Roman Izrailov, MD, PhD | Moscow Clinical Scientific Center | Study Chair |
| Boris Pomortsev, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lipetsk regional oncological center | Recruiting | Lipetsk | Russia |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| D061887 | Conversion to Open Surgery |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Open Surgery |
| Procedure |
Open surgery |
|
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 |
| Moscow Clinical Scientific Center |
| Principal Investigator |
| Pavel Kononets, MD, PhD | Moscow Oncological Hospital 62 | Principal Investigator |
| Andrey Ryabov, MD, PhD | P.Herzen Moscow Oncological Research Institute | Principal Investigator |
| Vladimir Lyadov, MD, PhD | Treatment and Rehabilitation Centre of Health Ministry of Russia | Principal Investigator |
| Alexey Karachun, MD, PhD | N. Petrov National Research Institute of Oncology | Principal Investigator |
| Victor Kashchenko, MD, PhD | Federal Medical Biology Agence №122 the name of L.Sokolov | Principal Investigator |
| Andrey Pavlenko, MD, PhD | Leningradsky oncological center | Principal Investigator |
| Michail Lando, MD, PhD | Lipetsk regional oncological center | Principal Investigator |
| Sergey Baydo, MD, PhD | Lisod clinic Kiev | Principal Investigator |
| Igor Khatkov, MD, PhD | Moscow Clinical Scientific Center | Study Director |
| Michail Prostov | Moscow Clinical Scientific Center | Principal Investigator |
| Kirill Schostka, MD, PhD | Leningradsky oncological center | Principal Investigator |
| Moscow Clinical Scientific Center | Recruiting | Moscow | 111123 | Russia |
|
| Moscow Oncology Hospital 62 | Recruiting | Moscow | Russia |
|
| P.Herzen Moscow Oncological Research Institute | Recruiting | Moscow | Russia |
|
| Treatment and Rehabilitation Centre of Health Ministry of Russia | Recruiting | Moscow | Russia |
|
| Federal Medical Biology Agence №122 the name of L.Soko | Recruiting | Saint Petersburg | Russia |
|
| Leningradsky oncological center | Recruiting | Saint Petersburg | Russia |
|
| N. Petrov National Research Institute of Oncology | Recruiting | Saint Petersburg | Russia |
|
| Lisod clinic | Recruiting | Kiev | Ukraine |
|
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |