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

Hepatectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06447181
• Other study ID #: 2023-KY-122-01
• Status: Not yet recruiting
• Start date: August 30, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2024
• Source: Zhujiang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 30, 2024
• Est. primary completion date: December 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatectomy
• Hepatolithiasis

Intervention

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.

Locations

Country	Name	City	State
China	Zhujiang Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	operation time	minutes	Perioperative period
Primary	intraoperative blood loss	ml	Perioperative period
Primary	intraoperative incidental injuries		Perioperative period
Secondary	Postoperative complications	Bile leak, pancreatic leak and stone residue	Perioperative period
Secondary	Repeat surgery rate		Perioperative period
Secondary	Serum bilirubin levels	mmol/L	Perioperative period