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

Phase 2

• Conditions: Liver Resection
• Interventions: Device: Laparoscopic surgical navigation system; Drug: Indocyanine Green

• Registration Number: NCT03811704
• Lead Sponsor: Zhujiang Hospital

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.

Study Timeline

• Study Start: 2016-01-01
• Status Verified: 2018-11
• Study First Submitted: 2018-12-02
• Study First Submitted QC: 2019-01-17
• Last Update Submitted: 2019-01-17
• Study First Posted: 2019-01-22
• Last Update Posted: 2019-01-22
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group	Laparoscopic surgical navigation system	Hepatectomy procedures were performed under Laparoscopic surgical navigation system and Indocyanine Green guidance.
Experimental group	Indocyanine Green	Hepatectomy procedures were performed under Laparoscopic surgical navigation system and Indocyanine Green guidance.

Primary Outcome Measures

Name	Time	Method
Liver resection navigation success rate	intraoperative	Whether this technique successfully displayed the pre-resection line during the surgery were recorded.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zhujiang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China