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

Liver Resection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03811704
• Other study ID #: 201802
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2016
• Est. completion date: December 30, 2021

Study information

• Verified date: November 2018
• Source: Zhujiang Hospital
• Contact: Fang Chihua, M.D.;Ph.D
• Phone: +8613609700805
• Email: fangch_dr[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Resection

Intervention

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.

Locations

Country	Name	City	State
China	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver resection navigation success rate	Whether this technique successfully displayed the pre-resection line during the surgery were recorded.	intraoperative
Secondary	Postoperative complication rate	The Postoperative complications were recorded.	3 months
Secondary	Operative outcomes	Operative outcomes such as operative time, estimated blood loss and blood transfusion were recorded.	intraoperative