Back to resultsA Clinical Study for Comparison of the Effects Between Gasless Laparoscopy and Conventional Laparoscopy for Distal Gastric Cancer
Primary Purpose
Gastrectomy, Laparoscopy
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Conventional Laparoscopy
Gasless Laparoscopy
Sponsored by
About this trial
This is an interventional treatment trial for Gastrectomy focused on measuring Laparoscopy-assisted Gastrectomy, Gastric cancer
Eligibility Criteria
Inclusion Criteria:
- Age >18 and <75 years old;
- 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]);
- Preoperative clinical staging of T2-4a, N0-3, M0 (see preoperative assessment program; tumor staging is in accordance with AJCC-7th TNM);
- 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)
- Preoperative ECOG status score of 0/1;
- Preoperative ASA (American society of anesthesiology) class of I -III;
- Patients signed informed consent.
Exclusion Criteria:
- Pregnant or lactating women;
- Serious mental illness;
- History of abdominal surgery (except for laparoscopic cholecystectomy);
- History of gastric surgery (including ESD/EMR for gastric cancer);
- Preoperative imaging examination suggests regional integration enlargement of lymph nodes (maximum diameter ≥3 cm)
- Other malignant disease history within five (5) years;
- Patients who received or were recommended a new adjuvant therapy;
- History of unstable angina or myocardial infarction within six (6) months;
- History of cerebral infarction or cerebral hemorrhage within six (6) months;
- History of sustained systemic corticosteroid therapy within one (1) month;
- Patients requiring simultaneous surgical treatment of other diseases;
- Gastric cancer complications (bleeding, perforation, obstruction) requiring emergency surgery;
- Pulmonary function test with FEV1 <50% of the expected value.
Sites / Locations
- Harbin University Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Gasless Laparoscopy-assisted Gastrectomy
Conventional Laparoscopy-assisted Gastrectomy
Arm Description
Patients receive Gasless Laparoscopy-assisted Gastrectomy with D2 Lymphadenectomy for Distal Gastric Cancer.
Patients receive Conventional Laparoscopy-assisted Gastrectomy with D2 Lymphadenectomy for Distal Gastric Cancer.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Blood pressure
Intraoperative blood pressure
End-tidal carbon dioxide
Intraoperative end-tidal carbon dioxide
Heart rate
Intraoperative heart rate
Estimated blood loss
Intraoperative estimated blood loss
Complications
Intraoperative complications
Death
Intraoperative death
Blood transfusion
Intraoperative and postoperative blood transfusion
Tumor size
Tumor size
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05495217
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xue Yingwei
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrectomy, Laparoscopy
Keywords
Laparoscopy-assisted Gastrectomy, Gastric cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gasless Laparoscopy-assisted Gastrectomy
Arm Type
Experimental
Arm Description
Patients receive Gasless Laparoscopy-assisted Gastrectomy with D2 Lymphadenectomy for Distal Gastric Cancer.
Arm Title
Conventional Laparoscopy-assisted Gastrectomy
Arm Type
Other
Arm Description
Patients receive Conventional Laparoscopy-assisted Gastrectomy with D2 Lymphadenectomy for Distal Gastric Cancer.
Intervention Type
Device
Intervention Name(s)
Conventional Laparoscopy
Other Intervention Name(s)
Laparoscopic Surgery
Intervention 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.
Intervention Type
Device
Intervention Name(s)
Gasless Laparoscopy
Other Intervention Name(s)
Gasless Laparoscopic Surgery
Intervention 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.
Primary Outcome Measure Information:
Title
Operative time
Description
The primary end point was operative time for Gasless Laparoscopy-assisted Gastrectomy with D2 Lymphadenectomy and conventional Laparoscopy-assisted Gastrectomy with D2 Lymphadenectomy.
Time Frame
During procedure.
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Intraoperative blood pressure
Time Frame
Through study completion, an average of 2 year.
Title
End-tidal carbon dioxide
Description
Intraoperative end-tidal carbon dioxide
Time Frame
Through study completion, an average of 2 year.
Title
Heart rate
Description
Intraoperative heart rate
Time Frame
Through study completion, an average of 2 year.
Title
Estimated blood loss
Description
Intraoperative estimated blood loss
Time Frame
Through study completion, an average of 2 year.
Title
Complications
Description
Intraoperative complications
Time Frame
Through study completion, an average of 2 year.
Title
Death
Description
Intraoperative death
Time Frame
Through study completion, an average of 2 year.
Title
Blood transfusion
Description
Intraoperative and postoperative blood transfusion
Time Frame
Through study completion, an average of 2 year.
Title
Tumor size
Description
Tumor size
Time Frame
Through study completion, an average of 2 year.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age >18 and <75 years old;
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]);
Preoperative clinical staging of T2-4a, N0-3, M0 (see preoperative assessment program; tumor staging is in accordance with AJCC-7th TNM);
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)
Preoperative ECOG status score of 0/1;
Preoperative ASA (American society of anesthesiology) class of I -III;
Patients signed informed consent.
Exclusion Criteria:
Pregnant or lactating women;
Serious mental illness;
History of abdominal surgery (except for laparoscopic cholecystectomy);
History of gastric surgery (including ESD/EMR for gastric cancer);
Preoperative imaging examination suggests regional integration enlargement of lymph nodes (maximum diameter ≥3 cm)
Other malignant disease history within five (5) years;
Patients who received or were recommended a new adjuvant therapy;
History of unstable angina or myocardial infarction within six (6) months;
History of cerebral infarction or cerebral hemorrhage within six (6) months;
History of sustained systemic corticosteroid therapy within one (1) month;
Patients requiring simultaneous surgical treatment of other diseases;
Gastric cancer complications (bleeding, perforation, obstruction) requiring emergency surgery;
Pulmonary function test with FEV1 <50% of the expected value.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yingwei Xue, doctor
Organizational Affiliation
Harbin Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Harbin University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150086
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Clinical Study for Comparison of the Effects Between Gasless Laparoscopy and Conventional Laparoscopy for Distal Gastric Cancer
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