Comparison of Open and Laparoscopic Distal Gastrectomy for T4a Gastric Cancer

Study Overview
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Brief Summary
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There are more than 75% of patients with gastric cancer who are diagnosed in advanced stage in Vietnam, most of cases in T4a. The purpose of this study is to compare the technical feasibility, early and long term outcomes of open and laparoscopic distal gastrectomy for gastric adenocarcinoma in T4A stage

Detailed Description
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Gastric cancer poses a significant public health problem. It is one of the most common cancers in Vietnam . Despite recent advances in multimodality treatment and targeted therapy, surgery remains the first option of treament for this disease. For resectable gastric cancer, complete removal of macroscopic and microscopic lesions and/or combined resections and also regional or extended lymphadenectomy should represent in the world now. Since laparoscopic gastrectomy for early gastric cancer (EGC) was firstly reported in 1994 , this technique has become standard for treatment of EGC due to the many advantages of mininally invasive surgery and also in oncologic outcomes. Laparoscopic gastrectomy for advanced gastric cancer AGC was first applied by Uyama in 2000, and then, many surgeons have used it for treatment of AGC, especially in Japan, Korea and China. However, the real role of laparoscop for treament of (AGC) is still controversial in term of technical feasibility, safety and oncologic aspect. Paragastric inflammatory strands may occur in T4a tumor so that laparoscopic technique is difficult to radically perform. Peritoneal seeding of malignant cells, intra- and postoperative complications, trocarts metastasis may risk during procedures. Despite, some studies have demonstrated the safety and the short-term benefits of LG for T4a gastric cancer, the number of these studies and sample sizes have been still inadequate to give good evidence for applying it. and long-term oncologic outcomes There are more than 75% of patients with gastric cancer who are diagnosed in advanced stage in Vietnam, most of cases in T4a. The purpose of this study is to compare the technical feasibility, early and long term outcomes of open and laparoscopic distal gastrectomy for gastric adenocarcinoma in T4A stage.

Official Title
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Comparison of Laparoscopic Versus Open Distal Gastrectomy for T4a Gastric Cancer: a Prospective Randomized Control Trial

Conditions
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Gastric Cancer

Intervention / Treatment
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* Procedure: Distal gastrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologic finding by gastric endoscopy: confirmed gastric adenocarcinoma Age: 18 - 80 year old Tumor located at the middle or lower third of the stomach Preoperative cancer stage (CT scan stage): cT4aN0M0, cT4aN1M0, cT4aN2M0, cT4aN3M0 ASA score: ≤ 3 Informed consent patients (explanation about our clinical trials is provided to the patients or patrons, if patient is not available) Exclusion Criteria: Concurrent cancer or patient who was treated due to other cancer before the patient was diagnosed gastric cancer Had another treatment methods, such as chemotherapy, immunotherapy, or radiotherapy Pregnant patient Combined resection Total gastrectomy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Open distal gastrectomy<br>An incision of 15 20 cm length is made in the abdominal midline . Standard distal gastrectomy and omentectomy will be performed with D2 lymph node dissection (around common hepatic artery, celiac artery, proximal part of splenic artery, proper hepatic artery) . As a general rule, Billroth II method was used for gastric reconstruction for most cases | Procedure: Distal gastrectomy<br>* Distal gastrectomy and standard D2 lymphadenectomy<br>|
| Experimental: Laparoscopic distal gastrectomy<br>5 trocar were used. The gastrocolic ligament was divided along the border of the transverse colon. ligating the left gastroepiploic vessels to remove group 4sb. The right gastroepiploic vein was divided and the right gastroepiploic and the inferior pyloric artery were vascularized and cut at their origin from the gastroduodenal artery, just above the pancreatic head, to dissect group 6. The dissection was continued along the hepatoduodenal ligament to removed group 5 and group 12a and along the common hepatic artery to remove group 8a and along the celiac axis to remove group 9. The left gastric vein was prepared and separately divided and then the left gastric artery was vascularized to remove group 7. The dissection was continued upward along the proximal branches of splenic vessels to remove group 11p and along the lesser curvature to remove group 1,3. As a general rule, Billroth II method was used for gastric reconstruction for most cases | Procedure: Distal gastrectomy<br>* Distal gastrectomy and standard D2 lymphadenectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 year overall survival by Kaplan Mayer | The percentage of people in this study who are alive three years after surgery. | 3 year after surgery | 
| 3 year relapse-free survival by Kaplan Mayer | The percentage of people in this study who are alive without recurrence three years after surgery. | 3 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative morbidity | The rate of postoperative bleeding and the rate of postoperative leakage | 30 days after surgery | 
| operative mortality | The rate of postoperative dead | 30 days after surgery | 
| hospital stay | The number of days between surgery and discharge | 30 days after surgery | 
| operative time | The duration of a surgical procedure in minutes. | intraoperative | 
| Resected lymph nodes | the number of lymph nodes harvested after surgery | intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer, laparoscopic gastrectomy, T4a stage