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

NCT ID: NCT05495217

Last Updated: 2022-08-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2023-12-01

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.

Conditions

Gastrectomy; Laparoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Gasless Laparoscopy-assisted Gastrectomy

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

Group Type: EXPERIMENTAL

Gasless Laparoscopy

Intervention Type: DEVICE

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.

Conventional Laparoscopy-assisted Gastrectomy

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

Group Type: OTHER

Conventional Laparoscopy

Intervention Type: DEVICE

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.

Interventions

Conventional Laparoscopy

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.

Intervention Type: DEVICE

Gasless Laparoscopy

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.

Intervention Type: DEVICE

Other Intervention Names

Laparoscopic Surgery; Gasless Laparoscopic Surgery

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xue Yingwei

OTHER

Sponsor Role: lead

Responsible Party

Xue Yingwei

Director, Head of Gastrointestinal surgery, Principal Investigator, Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yingwei Xue, doctor

Role: STUDY_DIRECTOR

Harbin Medical University

Locations

Harbin University Cancer Hospital

Harbin, Heilongjiang, China

Countries

China

Other Identifiers

XJS2021-13

Identifier Type: -

Identifier Source: org_study_id