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

August 21, 2020 updated by: Shanghai Minimally Invasive Surgery Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Minhua Zheng

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: laparoscopic gastrectomy with Intelligent Navigation 4K UHD 3D
Device: Laparoscopic gastrectomy with Intelligent Navigation 4K UHD 3D Endoscopic Imaging System
Laparoscopic gastrectomy with Intelligent Navigation 4K UHD 3D Endoscopic Imaging System

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Minimally Invasive Surgery Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 1, 2020

Primary Completion (ANTICIPATED)

October 1, 2022

Study Completion (ANTICIPATED)

October 1, 2022

Study Registration Dates

First Submitted

August 19, 2020

First Submitted That Met QC Criteria

August 21, 2020

First Posted (ACTUAL)

August 25, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 25, 2020

Last Update Submitted That Met QC Criteria

August 21, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LG-4K, 3D & ICG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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