Liver ResectionPhase 2NCT03811704
Real-time Navigation for Laparoscope Liver Resections Using Fusion 3D Imaging and Indocyanine Green Fluorescence Imaging
A Phase 2 study testing Laparoscopic surgical navigation system and Indocyanine Green in people with Liver Resection, run by Zhujiang Hospital at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Resection
- What is being tested?
- Laparoscopic surgical navigation system and Indocyanine Green
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 30 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510282
Chihua Fang, MD, (+86)2062782568, s_mountain@126.com
Qingshan Chen, MM, (+86)2062782568, s_mountain@126.com
About this study
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.
- Conditions
- Liver Resection
- Being tested
- Laparoscopic surgical navigation system, Indocyanine Green
- Keywords
- three-dimensional reconstruction, fluorescence, indocyanine green, liver resection, navigation surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic surgical navigation systemDevice
We will use this navigation system to guide de liver resection.
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Hepatectomy procedures were performed under Laparoscopic surgical navigation system and Indocyanine Green guidance. Receives: Device: Laparoscopic surgical navigation system; Drug: Indocyanine Green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver resection navigation success rate
Whether this technique successfully displayed the pre-resection line during the surgery were recorded.
Measured: intraoperative
Secondary outcomes (2)
Postoperative complication rate
The Postoperative complications were recorded.
Measured: 3 months
Operative outcomes
Operative outcomes such as operative time, estimated blood loss and blood transfusion were recorded.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start1 Jan 2016
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver ResectionStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chihua Fang, M.D.;Ph.D, Study director, China, Guangdong Zhujiang Hospital of The Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811704
- Sponsor's protocol ID
- 201802
- Status last verified
- Nov 2018
- First submitted
- 2 Dec 2018
- Last updated
- 22 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36648260
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Navigation for Laparoscope Liver Resections Using Fusion 3D Imaging and Indocyanine Green Fluorescence Imaging
- ClinicalTrials.gov ID
- NCT03811704
- Acronym / sponsor ID
- 201802
- Conditions
- Liver Resection
- Keywords
- three-dimensional reconstruction, fluorescence, indocyanine green, liver resection, navigation surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 22 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Laparoscopic surgical navigation system, Drug: Indocyanine GreenHepatectomy procedures were performed under Laparoscopic surgical navigation system and Indocyanine Green guidance. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic surgical navigation systemWe will use this navigation system to guide de liver resection. | Device | Experimental group |
| Indocyanine GreenICG 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. | Drug | Experimental group |
Primary outcome
Liver resection navigation success rate
Time frame: intraoperative
Whether this technique successfully displayed the pre-resection line during the surgery were recorded.
2 secondary outcomes
Postoperative complication rate
Time frame: 3 months
Operative outcomes
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
- Derived from this study: PubMed 36648260Zhu 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.
Related trials for Liver Resection
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Recruiting
Novel Method to Assess Hepatic Regeneration and Predict Hepatic Related Morbidity After Partial Hepatectomy
Liver Cancer Adult, Liver Regeneration
RecruitingPhase 1
Neoadjuvant Hypofractionated Stereotactic Body Radiation Therapy Prior to Surgery for Hepatocellular Carcinoma: a Feasibility Study.
Hepatocellular Carcinoma
Not yet recruitingPhase 3
Fruquintinib Combined With Capecitabine as Adjuvant Extended Therapy After R0 Resection and Perioperative Chemotherapy in Patients With Liver-Only Metastatic Colorectal Cancer
Colorectal Cancer
Active, not recruiting
Surgical Margin Assessment Using Intra-operative High-resolution PET/CT in Patients With Cancers Referred to Surgical Resection, an Exploratory Pilot Study
Breast Cancer, Head and Neck Cancers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chihua Fang, M.D.;Ph.D study director
China, Guangdong Zhujiang Hospital of The Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Laparoscopic surgical navigation system and Indocyanine Green in people with Liver Resection, run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fang Chihua, M.D.;Ph.D (+8613609700805, fangch_dr@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver resection navigation success rate (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03811704, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2019.