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
Verified date | August 2022 |
Source | The Third Affiliated Hospital of Harbin Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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. |
Country | Name | City | State |
---|---|---|---|
China | Harbin University Cancer Hospital | Harbin | Heilongjiang |
Lead Sponsor | Collaborator |
---|---|
Xue Yingwei |
China,
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. |
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