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

Stomach Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04526483
• Other study ID #: LG-4K, 3D & ICG
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: October 1, 2022

Study information

• Verified date: August 2020
• Source: Shanghai Minimally Invasive Surgery Center
• Contact: Junjun Ma
• Phone: 13917283686
• Email: zmhtiger[@]yeah.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 67
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Minimally Invasive Surgery Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The success rate of laparoscopic gastric surgery	Rate of successfully performed laparoscopic gastrectomy	24 months
Secondary	Lymph node dissection rate	The numbers of lymph node dissected in the surgery	24 months