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

Not Applicable

• Conditions: Gastrectomy; Laparoscopy
• Interventions: Device: Gasless Laparoscopy; Device: Conventional Laparoscopy

• Registration Number: NCT05495217
• Lead Sponsor: Xue Yingwei

Brief Summary

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

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 Timeline

• Study Start: 2021-12-01
• Study First Submitted: 2022-07-23
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-08
• Last Update Submitted: 2022-08-08
• Study First Posted: 2022-08-10
• Last Update Posted: 2022-08-10
• Primary Completion: 2023-06-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gasless Laparoscopy-assisted Gastrectomy	Gasless Laparoscopy	Patients receive Gasless Laparoscopy-assisted Gastrectomy with D2 Lymphadenectomy for Distal Gastric Cancer.
Conventional Laparoscopy-assisted Gastrectomy	Conventional Laparoscopy	Patients receive Conventional Laparoscopy-assisted Gastrectomy with D2 Lymphadenectomy for Distal Gastric Cancer.

Primary Outcome Measures

Name	Time	Method
Operative time	During procedure.	The primary end point was operative time for Gasless Laparoscopy-assisted Gastrectomy with D2 Lymphadenectomy and conventional Laparoscopy-assisted Gastrectomy with D2 Lymphadenectomy.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Harbin University Cancer Hospital; 🇨🇳 Harbin, Heilongjiang, China