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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05495217
Other study ID # XJS2021-13
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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