Clinical trial NCT04526483: L-Gastrectomy With the Intelligent Navigation 4K UHD 3D Endoscopic Imaging System
Official title: Safety and Efficacy of a Novel Intelligent Navigation 4K UHD 3D Endoscopic Imaging System in Laparoscopic Gastrectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stomach Neoplasms
Keywords: Laparoscopy
Gastrectomy
4K
3D
lymphadenectomy
Lead sponsor: Shanghai Minimally Invasive Surgery Center
Sponsor class: OTHER
First posted: 2020-08-25
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The success rate of laparoscopic gastric surgery
timeFrame: 24 months
Secondary outcomes:
measure: Lymph node dissection rate
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
References: