L-Gastrectomy With the Intelligent Navigation 4K UHD 3D Endoscopic Imaging System

Shanghai Minimally Invasive Surgery Center

Status: Unknown

Conditions: Stomach Neoplasms

Treatments: Device: Laparoscopic gastrectomy with Intelligent Navigation 4K UHD 3D Endoscopic Imaging System

Study type: Interventional

Funder types: Other

Identifiers

NCT04526483

LG-4K, 3D & ICG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 67 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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67 participants in 1 patient group

laparoscopic gastrectomy with Intelligent Navigation 4K UHD 3D

Experimental group

Treatment:

Device: Laparoscopic gastrectomy with Intelligent Navigation 4K UHD 3D Endoscopic Imaging System