CClinicalTrials.gg
Status unknownNCT03811704Updated Jan 22, 2019

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

A Phase 2 interventional study of Laparoscopic surgical navigation system and Indocyanine Green in Liver Resection, sponsored by Zhujiang Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-01-22.

Sponsored by Zhujiang Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2018), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 2 years 11 months after the study started (first participant enrolled Jan 2016, registered Dec 2018).
Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Liver Resection

Keywords

  • three-dimensional reconstruction
  • fluorescence
  • indocyanine green
  • liver resection
  • navigation surgery
03

In context

Lead sponsor

Zhujiang Hospital is the lead sponsor of 199 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Experimental group

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

    Device: Laparoscopic surgical navigation system · Drug: Indocyanine Green

Interventions

  • DeviceLaparoscopic surgical navigation system

    We will use this navigation system to guide de liver resection.

  • DrugIndocyanine 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.

06

What researchers measure

Primary outcomes

  1. Liver resection navigation success rate

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

    Time frame: intraoperative

Secondary outcomes

  1. Postoperative complication rate

    The Postoperative complications were recorded.

    Time frame: 3 months

  2. Operative outcomes

    Operative outcomes such as operative time, estimated blood loss and blood transfusion were recorded.

    Time frame: intraoperative

07

Study locations

1 of 1 sites recruiting
  • Zhujiang Hospital of Southern Medical University
    Guangzhou, Guangdong 510282, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03811704
Lead sponsor
Zhujiang Hospital
Responsible party
Sponsor
First posted
Jan 22, 2019
Start date
Jan 1, 2016
Primary completion
Dec 30, 2021 (estimated)
Completion
Dec 30, 2021 (estimated)
Last update
Jan 22, 2019

Study contacts

Fang Chihua, M.D.;Ph.D
Contact
fangch_dr@126.com
+8613609700805
Chihua Fang, M.D.;Ph.D
study director · China, Guangdong Zhujiang Hospital of The Southern Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion