A Clinical Study for Comparison of the Effects Between Gasless Laparoscopy and Conventional Laparoscopy for Distal Gastric Cancer

Study Overview
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Brief Summary
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The aim of this trial is to confirm the non-inferiority of Gasless laparoscopy-assisted distal D2 radical gastrectomy to the conventional laparoscopy-assisted distal D2 radical gastrectomy for the treatment of advanced gastric cancer patients (T2-4a, N0-3, M0).

Detailed Description
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The primary end point was operative time for Gasless laparoscopy-assisted distal D2 radical gastrectomy and conventional laparoscopy-assisted distal D2 radical gastrectomy. The secondary outcomes of interest were intraoperative vital signs; postoperative pain; and surgeon satisfaction for D2 radical gastrectomy.

Official Title
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A Single-center, Randomized, Controlled Clinical Study for Comparison of the Effects Between Gasless Laparoscopy-assisted and Conventional Laparoscopy-assisted Gastrectomy With D2 Lymphadenectomy for Distal Gastric Cancer

Conditions
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Gastrectomy, Laparoscopy

Intervention / Treatment
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* Device: Conventional Laparoscopy
* Device: Gasless Laparoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 and <75 years old; The gastric primary lesion is diagnosed as gastric adenocarcinoma by endoscopic biopsy histopathologic techniques (papillary adenocarcinoma [pap], tubular adenocarcinoma [tub], mucinous adenocarcinoma [muc], signet ring cell carcinoma [sig], and poorly differentiated adenocarcinoma [por]); Preoperative clinical staging of T2-4a, N0-3, M0 (see preoperative assessment program; tumor staging is in accordance with AJCC-7th TNM); It is expected that R0 surgical results will be obtained by distal subtotal gastrectomy and D2 lymph node dissection (also applies to multiple primary tumors) Preoperative ECOG status score of 0/1; Preoperative ASA (American society of anesthesiology) class of I -III; Patients signed informed consent. Exclusion Criteria: Pregnant or lactating women; Serious mental illness; History of abdominal surgery (except for laparoscopic cholecystectomy); History of gastric surgery (including ESD/EMR for gastric cancer); Preoperative imaging examination suggests regional integration enlargement of lymph nodes (maximum diameter ≥3 cm) Other malignant disease history within five (5) years; Patients who received or were recommended a new adjuvant therapy; History of unstable angina or myocardial infarction within six (6) months; History of cerebral infarction or cerebral hemorrhage within six (6) months; History of sustained systemic corticosteroid therapy within one (1) month; Patients requiring simultaneous surgical treatment of other diseases; Gastric cancer complications (bleeding, perforation, obstruction) requiring emergency surgery; Pulmonary function test with FEV1 <50% of the expected value.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Experimental: Gasless Laparoscopy-assisted Gastrectomy<br>Patients receive Gasless Laparoscopy-assisted Gastrectomy with D2 Lymphadenectomy for Distal Gastric Cancer. | Device: Gasless Laparoscopy<br>* A procedure in which a laparoscope (LAPAROSCOPES) is inserted through a small incision near the navel to examine the abdominal and pelvic organs in the PERITONEAL CAVITY without Induced pneumoperitoneum.It mechanically elevates the abdominal wall and allows laparoscopic visualization through a single incision, providing diagnostic and therapeutic procedures.<br>* Other names: Gasless Laparoscopic Surgery;|
| Other: Conventional Laparoscopy-assisted Gastrectomy<br>Patients receive Conventional Laparoscopy-assisted Gastrectomy with D2 Lymphadenectomy for Distal Gastric Cancer. | Device: Conventional Laparoscopy<br>* A procedure in which a laparoscope (LAPAROSCOPES) is inserted through a small incision near the navel to examine the abdominal and pelvic organs in the PERITONEAL CAVITY using Induced pneumoperitoneum.<br>* Other names: Laparoscopic Surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | The primary end point was operative time for Gasless Laparoscopy-assisted Gastrectomy with D2 Lymphadenectomy and conventional Laparoscopy-assisted Gastrectomy with D2 Lymphadenectomy. | During procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Intraoperative blood pressure | Through study completion, an average of 2 year. | 
| End-tidal carbon dioxide | Intraoperative end-tidal carbon dioxide | Through study completion, an average of 2 year. | 
| Heart rate | Intraoperative heart rate | Through study completion, an average of 2 year. | 
| Estimated blood loss | Intraoperative estimated blood loss | Through study completion, an average of 2 year. | 
| Complications | Intraoperative complications | Through study completion, an average of 2 year. | 
| Death | Intraoperative death | Through study completion, an average of 2 year. | 
| Blood transfusion | Intraoperative and postoperative blood transfusion | Through study completion, an average of 2 year. | 
| Tumor size | Tumor size | Through study completion, an average of 2 year. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopy-assisted Gastrectomy, Gastric cancer