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

Not Applicable

• Conditions: Stomach Neoplasms
• Interventions: Device: Laparoscopic gastrectomy with Intelligent Navigation 4K UHD 3D Endoscopic Imaging System

• Registration Number: NCT04526483
• Lead Sponsor: Shanghai Minimally Invasive Surgery Center

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.

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-19
• Study First Submitted QC: 2020-08-21
• Last Update Submitted: 2020-08-21
• Study First Posted: 2020-08-25
• Last Update Posted: 2020-08-25
• Study Start: 2020-10-01
• Primary Completion: 2022-10-01
• Study Completion: 2022-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 67

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
laparoscopic gastrectomy with Intelligent Navigation 4K UHD 3D	Laparoscopic gastrectomy with Intelligent Navigation 4K UHD 3D Endoscopic Imaging System	-

Primary Outcome Measures

Name	Time	Method
The success rate of laparoscopic gastric surgery	24 months	Rate of successfully performed laparoscopic gastrectomy

Secondary Outcome Measures

Name	Time	Method
Lymph node dissection rate	24 months	The numbers of lymph node dissected in the surgery