Arterial Base Fluorescence Segmental Positive Staining

February 10, 2020 updated by: Chang Gung Memorial Hospital

Superselective Intra-arterial Hepatic Injection of Indocyanine Green (ICG) for Fluorescence Image-guided Segmental Positive Staining

More and more laparoscopic hepatectomy were performed due to increasing experience, well designed instruments and energy device. But the localization of tumor and resection line design are still relative difficult comparing open approach due to limit space. Intraoperative liver segmentation can be obtained by ultrasound-guide intraportal injection of a fluorophore and illuminating with a Near-Infrared light source for positive staining and by intravenous injection after ligation of segmental vessels for negative staining .The ultrasound guide intraportal injection approach is challenging in the minimally-invasive setting. However hepatocelluar carcinoma(HCC) was supplied by hepatic artery mainly. The investigators aimed to evaluate the feasibility of arterial base positive staining for fluorescence liver segmentation in human by superselective intra-hepatic artery injection of Indocyanine Green (ICG) .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Materials and Methods

  1. Participants The present prospective, single-center, feasibility study of fluorescence demarcation of hepatic segment including HCC by means of direct super-selective intrahepatic artery ICG injection. Patients were enrolled according to the following criteria: single HCC, scheduled for laparoscopic hepatectomy for curative resection, age ranging from 20 to 85 years old, absence of proven or suspected allergies to iodine or ICG, absence of coagulopathy, absence of diseases contraindicating general anesthesia, and absence of pregnancy.

    All the bio-chemical test, cardiac echo , cardiac thalium test, ICG clearance test, Liver CT or MRI were obtained before operation

  2. Equipment Endovascular procedure was performed in the conventional angiography room and laparoscopic hepatecotmy was done in operating room at the Kaohsiung Chang Gung memorial hospital. Near infra-red fluorescence laparoscopy was used to acquire the fluorescence signal arising from the liver parenchyma after Indocyanine Green (ICG) injection.

  3. Procedures

    1. Celiac trunk angiography and super-selective hepatic angiography:

      A 4 Fr angiography sheath (Terumo Europe NV, Belgium) was placed under aseptic conditions in the right femoral artery, using the Seldinger technique. A 4 Fr Cobra-2 catheter (Terumo Europe NV, Belgium) was positioned at the origin of the celiac trunk. A selective celiac trunk digital subtraction angiographic (DSA) run was performed, after injection of a contrast medium (Visipaque 270, GE Healthcare; Buckinghamshire, United Kingdom), 28mL at a rate of 4mL/sec. A 2.7 French micro-catheter (Progreat™, Terumo Europe NV; Belgium) was used to super-selectively catheterize different hepatic segmental arteries supplying the target hepatic segment including HCC. In all cases, the position was controlled by performing DSA and angio computer tomography runs with selective micro-catheter injections. The micro-catheter was then perfused with saline and left in place until surgery. Then the patients were transferred to operative room while operative room available.

    2. Evaluation of hepatic segmental demarcation using NIR real-time imaging during laparoscopic hepatectomy:

The patients underwent a standard 5-port laparoscopic hepatectomy, which was performed by 2 experienced laparoscopic surgeons .

Stage I : the liver mobilization was performed for preparing the hepatectomy. The intraoperative ultrasound was used for localization of HCC. The resection line was defined as principle of laparoscopic hepatectomy such as surgical margin, surgical volume and etc. The pringle control device was prepared.

Stage II : Rea-time enhanced visualization of the hepatic segment which were supplied feeding artery was achieved by means of fluorescence imaging using a direct selective intrahepatic artery injection of a 5 mL bolus of ICG (DiagnoGreen®, Taiwan, ROC) at a concentration of 0.125mg/mL. The demarcation of enhanced hepatic segment were defined. The correspondence between the fluorescence margin and ultrasound(US) guide resection line were analized.

Stage III: The surgical resection line was chose by real time clinical judgement including analysis of information of US, artery-base CT, fluorescence image, liver anatomy and patient condition. The laparoscopic hepatectomy was performed with pringle vascular control.

Stage IV: the specimen information including tumor size and margin in vitro was recoded. The distance between surgical margin and enhanced liver were measured.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Kaohsiung
      • Niaosong, Kaohsiung, Taiwan, 833
        • Chang Gung memorial hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Single Hepatocellular carcinoma.
  • plan of Laparoscopic hepatectomy.
  • Age between 20 to 85 y/o.

Exclusion Criteria:

  • allergies to iodine or ICG
  • Liver cirrhosis
  • coagulopathy
  • chronic kidney disease
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: super-selective hepatic artery ICG injection group
single arm for feasibility study of intra-hepatic artery base fluorescent segmental demarcation
Procedure: Superselective Intra-arterial Hepatic Injection of Indocyanine Green (ICG) for Fluorescence Image-guided Segmental Positive Staining
The patients with single HCC which is planned to received laparoscopic hepatectomy were involved. Procedures were performed in conventional angiography room. The celiac trunk was catheterized and a microcatheter was advanced into segmental hepatic artery branches which supplied the HCC. The 5cc 0.125 mg/cc ICG was injected from super-selective hepatic artery in operative room. A Near-Infrared laparoscope was used to detect the fluorescent signal to assess the correspondence between arterial-based fluorescence demarcation and ultrasound-based surgical demarcation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fluorescent hepatic segment demarcation area
Time Frame: intra-operative period
The surface size of fluorescent enhanced hepatic segment were measured as cm x cm .
intra-operative period
the rate of fluorescent demarcation corresponding to US guide resection area
Time Frame: intra-operative period
The evaluation of the fluorescent hepatic surface which is included in the resected area or not
intra-operative period
The minimal distance between tumor and fluorescent margin
Time Frame: intra-operative period
The distance between tumor edge and fluorescent parenchyma edge was measured as cm. This purpose was to evaluation the oncologic safety if the resection line is following the fluorescent margin
intra-operative period
The minimal surgical margin
Time Frame: intra-operative period
The distance between tumor edge and resected parenchyma edge was measured as cm.
intra-operative period
surgical benefit rate of fluorescent image
Time Frame: intra-operative period
If the fluorescent enhanced area is similar to resected parenchyma or the information of fluorescent image change the primary surgical plan, it was indicated benefit for surgery.
intra-operative period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative complication
Time Frame: one months after operation
any complication related to surgery
one months after operation
Post operative angiography procedure complication
Time Frame: one months after operation
any complication related to angiography procedure
one months after operation
Post operative hospital stay
Time Frame: one months after operation
The day in hospital after operation
one months after operation
Post operative Mortality
Time Frame: any complication related to surgery
any mortality related to surgery
any complication related to surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Study Director: Yu-Yin Liu, MD, Chang Gung memorial hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2018

Primary Completion (Actual)

December 6, 2019

Study Completion (Actual)

January 6, 2020

Study Registration Dates

First Submitted

February 6, 2020

First Submitted That Met QC Criteria

February 10, 2020

First Posted (Actual)

February 12, 2020

Study Record Updates

Last Update Posted (Actual)

February 12, 2020

Last Update Submitted That Met QC Criteria

February 10, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGMH-20170147A3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

due to special technique, data is unique and difficult to fit with other study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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