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

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).

Study Overview

• Status: Unknown
• Conditions: Liver Resection
• Intervention / Treatment: Device: Laparoscopic surgical navigation system; Drug: Indocyanine Green

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Fang Chihua, M.D.;Ph.D; Phone Number: +8613609700805; Email: fangch_dr@126.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510282
      • Recruiting
      • Zhujiang Hospital of Southern Medical University
      • Contact: Chihua Fang, MD; Phone Number: (+86)2062782568; Email: s_mountain@126.com
      • Contact: Qingshan Chen, MM; Phone Number: (+86)2062782568; Email: s_mountain@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 18 years≤ Age ≤70 years
2. Compling with the diagnosis criteria of complex hepatic carcinoma.
3. Primary hepatic carcinoma without intrahepatic or extrahepatic extensive cancer metastasis, the metastatic hepatic carcinoma whose primary focal has been controlled
4. Preoperative liver function is Child - Pugh grade A or B.
5. The patients are volunteered for the study.

Exclusion Criteria:

1. Patients with mental illness.
2. 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.)
3. The patients refused to take part in the study.
4. There are other co-existed malignant tumors.
5. Benign liver diseases.
6. Indocyanine green allergy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental group; Hepatectomy procedures were performed under Laparoscopic surgical navigation system and Indocyanine Green guidance.

Device: Laparoscopic surgical navigation system; We will use this navigation system to guide de liver resection.; Drug: Indocyanine Green; ICG was administered 24 hours before the operation or intravenously after clamping the Glissonian sheaths flowing in the cancer-bearing hepatic segment, or directly into the portal branches supplying blood flow to the tumor-bearing hepatic segment, after puncturing of the target segments under intraoperative ultrasonography guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver resection navigation success rate	Whether this technique successfully displayed the pre-resection line during the surgery were recorded.	intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complication rate	The Postoperative complications were recorded.	3 months
Operative outcomes	Operative outcomes such as operative time, estimated blood loss and blood transfusion were recorded.	intraoperative

Collaborators and Investigators

• Sponsor: Zhujiang Hospital
• Investigators: Study Director: Chihua Fang, M.D.;Ph.D, China, Guangdong Zhujiang Hospital of The Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Anticipated): December 30, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: December 2, 2018
• First Submitted That Met QC Criteria: January 17, 2019
• First Posted (Actual): January 22, 2019

Study Record Updates

• Last Update Posted (Actual): January 22, 2019
• Last Update Submitted That Met QC Criteria: January 17, 2019
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: indocyanine green; fluorescence; liver resection; three-dimensional reconstruction; navigation surgery
• Other Study ID Numbers: 201802

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No