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

Xue Yingwei

Status: Active, not recruiting

Conditions: Laparoscopy; Gastrectomy

Treatments: Device: Gasless Laparoscopy; Device: Conventional Laparoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT05495217

XJS2021-13

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Gasless Laparoscopy-assisted Gastrectomy

Experimental group

Description:

Patients receive Gasless Laparoscopy-assisted Gastrectomy with D2 Lymphadenectomy for Distal Gastric Cancer.

Treatment:

Device: Gasless Laparoscopy

Conventional Laparoscopy-assisted Gastrectomy

Other group

Description:

Patients receive Conventional Laparoscopy-assisted Gastrectomy with D2 Lymphadenectomy for Distal Gastric Cancer.

Treatment:

Device: Conventional Laparoscopy