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

Xue Yingwei200 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

200

Conditions

Gastrectomy Laparoscopy

Interventions

Conventional LaparoscopyDEVICE

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.

Gasless LaparoscopyDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age \>18 and \<75 years old; 2. 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 \[por\]); 3. Preoperative clinical staging of T2-4a, N0-3, M0 (see preoperative assessment program; tumor staging is in accordance with AJCC-7th TNM); 4. 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) 5. Preoperative ECOG status score of 0/1; 6. Preoperative ASA (American society of anesthesiology) class of I -III; 7. Patients signed informed consent. Exclusion Criteria: 1. Pregnant or lactating women; 2. Serious mental illness; 3. History of abdominal surgery (except for laparoscopic cholecystectomy); 4. History of gastric surgery (including ESD/EMR for gastric cancer); 5. Preoperative imaging examination suggests regional integration enlargement of lymph nodes (maximum diameter ≥3 cm) 6. Other malignant disease history within five (5) years; 7. Patients who received or were recommended a new adjuvant therapy; 8. History of unstable angina or myocardial infarction within six (6) months; 9. History of cerebral infarction or cerebral hemorrhage within six (6) months; 10. History of sustained systemic corticosteroid therapy within one (1) month; 11. Patients requiring simultaneous surgical treatment of other diseases; 12. Gastric cancer complications (bleeding, perforation, obstruction) requiring emergency surgery; 13. Pulmonary function test with FEV1 \<50% of the expected value.

Locations (1)

Harbin University Cancer Hospital

Harbin, Heilongjiang, China

Outcomes

Primary Outcomes

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.

Time frame: During procedure.