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Clinical Trials/NCT03811704
NCT03811704
Unknown
Phase 2

Real-time Navigation for Laparoscope Liver Resections Using Fusion 3D Imaging and Indocyanine Green Fluorescence Imaging

Zhujiang Hospital1 site in 1 country50 target enrollmentJanuary 1, 2016

Overview

Phase
Phase 2
Intervention
Laparoscopic surgical navigation system
Conditions
Liver Resection
Sponsor
Zhujiang Hospital
Enrollment
50
Locations
1
Primary Endpoint
Liver resection navigation success rate
Last Updated
7 years ago

Overview

Brief Summary

The aim of this study was to evaluate the feasibility and efficacy of a novel real-time navigation way for laparoscope liver resection, which was fused images comprising 3D imaging and indocyanine green Fluorescence imaging (fusion IGFI).

Detailed Description

During liver resection, surgeons cannot completely view the intraparenchymal structure. Although a fluorescent imaging technique using indocyanine green has recently been developed for hepatobiliary surgery, limitations in its application for real-time navigation persist. A nove augmented reality surgery navigation system (ARSNS) can be combined with indocyanine green Fluorescence imaging to guide the surgery real-time.

Registry
clinicaltrials.gov
Start Date
January 1, 2016
End Date
December 30, 2021
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Zhujiang Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 18 years≤ Age ≤70 years
  • Compling with the diagnosis criteria of complex hepatic carcinoma.
  • Primary hepatic carcinoma without intrahepatic or extrahepatic extensive cancer metastasis, the metastatic hepatic carcinoma whose primary focal has been controlled
  • Preoperative liver function is Child - Pugh grade A or B.
  • The patients are volunteered for the study.

Exclusion Criteria

  • Patients with mental illness.
  • Patients can't tolerate the operation owe to a variety of basic diseases (such as severe cardiopulmonary insufficiency, renal insufficiency, cachexia and blood system diseases, etc.)
  • The patients refused to take part in the study.
  • There are other co-existed malignant tumors.
  • Benign liver diseases.
  • Indocyanine green allergy

Arms & Interventions

Experimental group

Hepatectomy procedures were performed under Laparoscopic surgical navigation system and Indocyanine Green guidance.

Intervention: Laparoscopic surgical navigation system

Experimental group

Hepatectomy procedures were performed under Laparoscopic surgical navigation system and Indocyanine Green guidance.

Intervention: Indocyanine Green

Outcomes

Primary Outcomes

Liver resection navigation success rate

Time Frame: intraoperative

Whether this technique successfully displayed the pre-resection line during the surgery were recorded.

Secondary Outcomes

  • Postoperative complication rate(3 months)
  • Operative outcomes(intraoperative)

Study Sites (1)

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