Randomized Controlled Trials Comparing Clinical Outcomes of 3D Versus 2D Laparoscopic Surgery for Gastric Cancer

Study Overview
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Brief Summary
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The purpose of this study is to explore the feasibility, safety, and efficacy of 3D Laparoscopic Surgery for Gastric Cancer. The patients with gastric adenocarcinoma (cT1-4aN0-3M0) were studied.

Detailed Description
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A prospective randomized comparison of 3D and 2D laparoscopic surgery for gastric cancer will be performed, to evaluate the clinical value and provide theoretical basis and clinical experience for the extensive application of the 3D laparoscopic technique. The evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function and 3-year/5-year survival and recurrence rates.

Official Title
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Randomized Controlled Trials Comparing Clinical Outcomes of 3D Versus 2D Laparoscopic Surgery for Gastric Cancer

Conditions
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Stomach Neoplasms

Intervention / Treatment
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* Procedure: 3D Laparoscopic Surgery
* Procedure: 2D Laparoscopic Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (1)Age from over 19 to under 74 years (2)cT1-4a(clinical stage tumor), N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition (3)Heart, lungs, kidneys, and other vital organs function well, with no obvious surgical contraindications (4)Preoperative examination with no distant metastasis, no significantly enlarged lymph nodes around the main abdominal artery, and tumor not a direct violation of the pancreas, spleen, and other surrounding organs (5)American Society of Anesthesiology (ASA) score class I, II, or III (6)Written informed consent Exclusion Criteria: (1)Women during pregnancy or breast-feeding (2)Severe mental disorder (3)History of previous upper abdominal surgery (except laparoscopic cholecystectomy) (4)Enlarged splenic hilar lymph nodes with integration into a mass and surrounding the blood vessels (5)History of unstable angina or myocardial infarction within the past six months (6)History of cerebrovascular accident within the past six months (7)History of continuous systematic administration of corticosteroids within one month (8)History of previous neoadjuvant chemotherapy or radiotherapy (9)T4b tumors (10)Emergency surgery due to complication (bleeding, obstruction, or perforation) caused by gastric cancer (11)FEV1(Forced expiratory volume in one second)<50% of predicted values

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 74 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D Laparoscopic Surgery<br>3D Laparoscopic Surgery will be performed for the treatment of patients assigned to this group. | Procedure: 3D Laparoscopic Surgery<br>* After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, 3D laparoscopic gastrectomy will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience.<br>|
| Active Comparator: 2D Laparoscopic Surgery<br>2D Laparoscopic Surgery will be performed for the treatment of patients assigned to this group. | Procedure: 2D Laparoscopic Surgery<br>* After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, 2D laparoscopic gastrectomy will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operating time | Operating time | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative situation | The number of lymph node dissection, the number of positive lymph nodes, intraoperative lymph node dissection time(regional analysis: infrapyloric area lymph node, suprapancreatic area lymph node, splenic hilar area lymph node, cardial area lymph node), intracavitary anastomosis time(patients who undergo totally laparoscopic surgery are analyzed), intraoperative blood loss, intraoperative injury, the amount of use of titanium clip, the rate of conversion to laparotomy | 1 day | 
| Postoperative recovery course | Time to first ambulation, flatus, liquid diet and soft diet, duration of postoperative hospital stay and postoperative pain are used to assess the postoperative recovery course.Visual analog pain score method is used to evaluate the difference of postoperative pain degree. | 10 days | 
| Complication | Early complications occurred within 30 days after operation: pulmonary infection, incision complication, intestinal obstruction, abdominal infection, anastomotic bleeding, anastomotic fistula, gastric emptying; Long-term complications (30 days later after operation): anastomotic stenosis, intestinal obstruction, dumping syndrome | 30 days;36 months | 
| The postoperative pathology | The postoperative pathological type and pTNM stage. | 7 days | 
| Inflammatory and immune response | The daily highest body temperature before discharge and the values of white blood cell count, hemoglobin, C-reactive protein, prealbumin and relevant immune cytokines including T cell percentage, T-helper lymphocytes (CD4+) percentage, T-suppressor lymphocytes (CD8+) percentage, natural killer (NK) cells percentage from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded. | 7 days | 
| Morbidity and mortality | The early postoperative complication and mortality are defined as the event observed within 30 days after surgery, while the time frame for late complication is the period from postoperative day 31th to the end of month 36th. | 30 days;36 months | 
| Hospitalization expenses | The cost from admission to discharge | 1 months | 
| 3-year disease free survival rate | Disease-free survival was defined as the time from surgery to the time of recurrence or death from any cause | 36 months | 
| 3-year overall survival rate | Overall survival was defined as the time from surgery to death from any cause | 36 months | 
| 5-year disease free survival rate | Disease-free survival was defined as the time from surgery to the time of recurrence or death from any cause | 60 months | 
| 5-year overall survival rate | Overall survival was defined as the time from surgery to death from any cause | 60 months | 
| Recurrence patterns | Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type. | 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stomach Neoplasms Laparoscopy