Stomach Neoplasms
Conditions
Keywords
Laparoscopy, Gastrectomy, 4K, 3D, lymphadenectomy
Brief summary
This study aims to evaluate the safety, efficacy, and feasibility of the Intelligent Navigation 4K UHD 3D Endoscopic Imaging System in patients with gastric cancer.
Detailed description
Background: Lymphadenectomy in laparoscopic gastrectomy can significantly improve the long-term survival and accuracy of the tumor staging of patients with gastric cancer. The retrieval of more lymph nodes has gradually become a trend among surgeons. However, lymphadenectomy is currently performed without the aid of visual instruments which might lead to an unknown pathological outcome and influence the prognosis of gastric cancer patients. And none of the indocyanine green (ICG) fluorescent imaging systems applied in clinical practice now is equipped with ultra-high definition (4K) or three-dimensional (3D) lens. To explore the advent of minimally invasive surgery with a conveniently switchable high-quality imaging system, we designed a new laparoscopic navigating technique that combined all the three characteristics. Aims: This study aims to evaluate the safety, efficacy, and feasibility of the Intelligent Navigation 4K UHD 3D Endoscopic Imaging System in patients with gastric cancer. Methods/design This is a prospective, one-arm, single-center, single-set target value clinical trial to investigate the clinical value of the Intelligent Navigation 4K UHD 3D Endoscopic Imaging System on laparoscopic gastric surgery. The trial will recruit a total of 67 participants.
Interventions
DEVICELaparoscopic gastrectomy with Intelligent Navigation 4K UHD 3D Endoscopic Imaging System
Laparoscopic gastrectomy with Intelligent Navigation 4K UHD 3D Endoscopic Imaging System
Sponsors
Shanghai Minimally Invasive Surgery Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a prospective, one-arm, single-center, single-set target value clinical trial to investigate the clinical value of the Intelligent Navigation 4K UHD 3D Endoscopic Imaging System on laparoscopic gastric surgery. The trial will recruit a total of 67 participants.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosed with gastric cancer require surgery; 2. Without a history of abdominal surgery; 3. BMI ≤ 30 kg/m2; 4. Preoperative ECOG score is 0\ 1 and ASA score is I\ III; 5. Having signed the Medical Informed Consent.
Exclusion criteria
1. Patients with metastasis or invasion of surrounding tissues; 2. Undergoing emergency operation (perforation, hemorrhage, obstruction); 3. Patients with serious medical co-morbidity (heart, lung, liver and kidney diseases) and could not tolerate laparoscopic surgery; 4. With poor incorrigible physical condition before surgery; 5. The patient who underwent gastrojejunostomy or jejunostomy; 6. The patient who refuses to accept standardized postoperative systemic therapy according to the guidelines.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The success rate of laparoscopic gastric surgery | 24 months | Rate of successfully performed laparoscopic gastrectomy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lymph node dissection rate | 24 months | The numbers of lymph node dissected in the surgery |
Contacts
Primary ContactJunjun Ma
Backup ContactMinhua Zheng
Outcome results
None listed