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Trial Title:
A Clinical Study for Comparison of the Effects Between Gasless Laparoscopy and Conventional Laparoscopy for Distal Gastric Cancer
NCT ID:
NCT05495217
Condition:
Gastrectomy
Laparoscopy
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
Laparoscopy-assisted Gastrectomy
Gastric cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Device
Intervention name:
Conventional Laparoscopy
Description:
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.
Arm group label:
Conventional Laparoscopy-assisted Gastrectomy
Other name:
Laparoscopic Surgery
Intervention type:
Device
Intervention name:
Gasless Laparoscopy
Description:
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.
Arm group label:
Gasless Laparoscopy-assisted Gastrectomy
Other name:
Gasless Laparoscopic Surgery
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Harbin University Cancer Hospital
Address:
City:
Harbin
Zip:
150086
Country:
China
Start date:
December 1, 2021
Completion date:
December 1, 2023
Lead sponsor:
Agency:
Xue Yingwei
Agency class:
Other
Source:
The Third Affiliated Hospital of Harbin Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05495217
