NCT03811704

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2016

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 22, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

January 22, 2019

Status Verified

November 1, 2018

Enrollment Period

6 years

First QC Date

December 2, 2018

Last Update Submit

January 17, 2019

Conditions

Liver Resection

Keywords

three-dimensional reconstructionfluorescenceindocyanine greenliver resectionnavigation surgery

Outcome Measures

Primary Outcomes (1)

  • Liver resection navigation success rate

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

    intraoperative

Secondary Outcomes (2)

  • Postoperative complication rate

    3 months

  • Operative outcomes

    intraoperative

Study Arms (1)

Experimental group

EXPERIMENTAL

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

Device: Laparoscopic surgical navigation systemDrug: Indocyanine Green

Interventions

Laparoscopic surgical navigation systemDEVICE

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

Experimental group
Indocyanine GreenDRUG

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.

Experimental group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510282, China

RECRUITING

Related Publications (1)

  • Zhu W, Zeng X, Hu H, Xiang N, Zeng N, Wen S, Tian J, Yang J, Fang C. Perioperative and Disease-Free Survival Outcomes after Hepatectomy for Centrally Located Hepatocellular Carcinoma Guided by Augmented Reality and Indocyanine Green Fluorescence Imaging: A Single-Center Experience. J Am Coll Surg. 2023 Feb 1;236(2):328-337. doi: 10.1097/XCS.0000000000000472. Epub 2022 Nov 8.

    PMID: 36648260DERIVED

MeSH Terms

Interventions

Indocyanine Green

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Chihua Fang, M.D.;Ph.D

    China, Guangdong Zhujiang Hospital of The Southern Medical University

    STUDY DIRECTOR

Central Study Contacts

Fang Chihua, M.D.;Ph.D

CONTACT

+8613609700805fangch_dr@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2018

First Posted

January 22, 2019

Study Start

January 1, 2016

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

January 22, 2019

Record last verified: 2018-11

Locations

CN(1)