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

Not yet recruiting

• Conditions: Hepatolithiasis; Hepatectomy
• Interventions: Device: 3D visualization technology ; ICG fluorescence technology .

• Registration Number: NCT06447181
• Lead Sponsor: Zhujiang Hospital

Brief Summary

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.

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 Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-30
• Study First Submitted QC: 2024-06-03
• Last Update Submitted: 2024-06-03
• Study First Posted: 2024-06-07
• Last Update Posted: 2024-06-07
• Study Start: 2024-08-30
• Primary Completion: 2024-12-25
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
3DVT-FI Group	3D visualization technology ; ICG fluorescence technology .	Patients with hepatolithiasis using 3D visualization combined with ICG fluorescence technique

Primary Outcome Measures

Name	Time	Method
intraoperative incidental injuries	Perioperative period
intraoperative blood loss	Perioperative period	ml
operation time	Perioperative period	minutes

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	Perioperative period	Bile leak, pancreatic leak and stone residue
Repeat surgery rate	Perioperative period
Serum bilirubin levels	Perioperative period	mmol/L

Trial Locations

Locations (1)

Zhujiang Hospital; 🇨🇳 Guangzhou, Guangdong, China