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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2022-10-01

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.

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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.

Conditions

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Stomach Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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laparoscopic gastrectomy with Intelligent Navigation 4K UHD 3D

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Interventions

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No