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

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: Hepatectomy; Hepatolithiasis
• Intervention / Treatment: Device: 3D visualization technology ; ICG fluorescence technology .

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

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510280
      • Zhujiang Hospital
      • Contact: Ning Zeng, Doctor; Phone Number: +86 +8613760694012; Email: chen_ning16@foxmail.com

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

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	minutes	Perioperative period
intraoperative blood loss	ml	Perioperative period
intraoperative incidental injuries		Perioperative period

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zhujiang Hospital

Study record dates

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: ICG; hepatolithiasis; Three-dimensional visualization
• 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