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

Laparoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05495217
• Other study ID #: XJS2021-13
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: August 2022
• Source: The Third Affiliated Hospital of Harbin Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastrectomy
• Laparoscopy
• Stomach Neoplasms

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
China	Harbin University Cancer Hospital	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
Xue Yingwei

Country where clinical trial is conducted

China, 

Outcome

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