Clinical trial NCT05495217: A Clinical Study for Comparison of the Effects Between Gasless Laparoscopy and Conventional Laparoscopy for Distal Gastric Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrectomy
Laparoscopy
Keywords: Laparoscopy-assisted Gastrectomy
Gastric cancer
Lead sponsor: The Third Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
First posted: 2022-08-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Operative time
timeFrame: During procedure.
Secondary outcomes:
measure: Blood pressure
timeFrame: Through study completion, an average of 2 year.
measure: End-tidal carbon dioxide
timeFrame: Through study completion, an average of 2 year.
measure: Heart rate
timeFrame: Through study completion, an average of 2 year.
measure: Estimated blood loss
timeFrame: Through study completion, an average of 2 year.
measure: Complications
timeFrame: Through study completion, an average of 2 year.
measure: Death
timeFrame: Through study completion, an average of 2 year.
measure: Blood transfusion
timeFrame: Through study completion, an average of 2 year.
measure: Tumor size
timeFrame: Through study completion, an average of 2 year.
Other outcomes:
Locations:
city: Harbin
country: China
facility: Harbin University Cancer Hospital
state: Heilongjiang
Study officials:
affiliation: Harbin Medical University
name: Yingwei Xue, doctor
role: STUDY_DIRECTOR
References: