Application of Three- Dimensional Visualization Combined With ICG Molecular Fluorescence Imaging in Hepatolithiasis

June 3, 2024 updated by: Zhujiang Hospital

A Retrospective Cohort Study of Three- Dimensional Visualization Combined With ICG Molecular Fluorescence Imaging in Hepatolithiasis.

This study adopted a retrospective study method to explore the clinical application value of 3D visualization combined with ICG molecular fluorescence imaging technology in hepatolithiasis, and further analyze whether 3D visualization combined with ICG molecular fluorescence imaging technology can improve the prognosis of hepatolithiasis by comparing with conventional surgery.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Hepatolithiasis is a complex and intractable benign disease, often called "benign disease with poor prognosis". Clinical practice has proved that the diagnosis and treatment platform for hepatolithiasis built by modern digital image technologies such as 3D visualization and Indocine green fluorescence image navigation technology plays a vital leading role in accurate preoperative assessment, location of the lesion, formulation of the best surgical plan, and intraoperative navigation to avoid collateral damage. The clinical practice has proved that the diagnosis and treatment platform for hepatolithiasis built by modern digital image technologies such as 3D visualization and ICG fluorescence image navigation plays a vital leading role in accurate preoperative assessment, location of the lesion, formulation of the best surgical plan, and intraoperative navigation to avoid collateral damage.Therefore, we want to conduct a retrospective cohort study to explore the application value of 3D visualization combined with ICG fluorescence technology in hepatolithiasis, in order to further improve the curative effect of hepatolithiasis.

Study Type

Observational

Enrollment (Estimated)

100

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

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510280

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with hepatolithiasis were ≥18 years old, and had undergone surgical treatment.

Description

Inclusion Criteria:

  • Patients aged ≥18 years, of any gender; The diagnosis was hepatolithiasis；Surgical treatment has been performed.

Exclusion Criteria:

  • Patients with severe cardiac, pulmonary, cerebral, renal dysfunction or other clinical contraindications who are unable to tolerate surgical treatment; Patients with malignant transformation; Lack of clinical data.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
3DVT-FI Group
Patients with hepatolithiasis using 3D visualization combined with ICG fluorescence technique
Device: 3D visualization technology ; ICG fluorescence technology .

Three-dimensional reconstruction technology is a software that can collect CT and MRI data, perform image segmentation and three-dimensional reconstruction of the liver, gallbladder, dilated bile ducts, pancreas, venous, and arterial systems step by step.

ICG fluorescence technology is a fluorescent laparoscopic technology that can detect extrahepatic biliary duct misalignment, improving surgical precision and safety.
Conventional operation Group
Patients with hepatolithiasis using conventional operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operation time
Time Frame: Perioperative period
minutes
Perioperative period
intraoperative blood loss
Time Frame: Perioperative period
ml
Perioperative period
intraoperative incidental injuries
Time Frame: Perioperative period
Perioperative period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: Perioperative period
Bile leak, pancreatic leak and stone residue
Perioperative period
Repeat surgery rate
Time Frame: Perioperative period
Perioperative period
Serum bilirubin levels
Time Frame: Perioperative period
mmol/L
Perioperative period

Collaborators and Investigators

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

Sponsor

Zhujiang Hospital

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 (Estimated)

August 30, 2024

Primary Completion (Estimated)

December 25, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

April 30, 2024

First Submitted That Met QC Criteria

June 3, 2024

First Posted (Actual)

June 7, 2024

Study Record Updates

Last Update Posted (Actual)

June 7, 2024

Last Update Submitted That Met QC Criteria

June 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023-KY-122-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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