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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety and Efficacy of a Novel Intelligent Navigation 4K UHD 3D Endoscopic Imaging System in Laparoscopic Gastrectomy

Conditions
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Stomach Neoplasms

Intervention / Treatment
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* Device: Laparoscopic gastrectomy with Intelligent Navigation 4K UHD 3D Endoscopic Imaging System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with gastric cancer require surgery; Without a history of abdominal surgery; BMI ≤ 30 kg/m2; Preoperative ECOG score is 0 1 and ASA score is I III; Having signed the Medical Informed Consent. Exclusion Criteria: Patients with metastasis or invasion of surrounding tissues; Undergoing emergency operation (perforation, hemorrhage, obstruction); Patients with serious medical co-morbidity (heart, lung, liver and kidney diseases) and could not tolerate laparoscopic surgery; With poor incorrigible physical condition before surgery; The patient who underwent gastrojejunostomy or jejunostomy; The patient who refuses to accept standardized postoperative systemic therapy according to the guidelines.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: laparoscopic gastrectomy with Intelligent Navigation 4K UHD 3D<br> | Device: Laparoscopic gastrectomy with Intelligent Navigation 4K UHD 3D Endoscopic Imaging System<br>* Laparoscopic gastrectomy with Intelligent Navigation 4K UHD 3D Endoscopic Imaging System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The success rate of laparoscopic gastric surgery | Rate of successfully performed laparoscopic gastrectomy | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lymph node dissection rate | The numbers of lymph node dissected in the surgery | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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4K, Laparoscopy, Gastrectomy, 3D, lymphadenectomy