Clinical trial NCT06447181: Application of Three- Dimensional Visualization Combined With ICG Molecular Fluorescence Imaging in Hepatolithiasis
Official title: A Retrospective Cohort Study of Three- Dimensional Visualization Combined With ICG Molecular Fluorescence Imaging in Hepatolithiasis.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hepatolithiasis
Hepatectomy
Keywords: Three-dimensional visualization
ICG
hepatolithiasis
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hepatolithiasis were ≥18 years old, and had undergone surgical treatment.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: operation time
timeFrame: Perioperative period
measure: intraoperative blood loss
timeFrame: Perioperative period
measure: intraoperative incidental injuries
timeFrame: Perioperative period
Secondary outcomes:
measure: Postoperative complications
timeFrame: Perioperative period
measure: Repeat surgery rate
timeFrame: Perioperative period
measure: Serum bilirubin levels
timeFrame: Perioperative period
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital
state: Guangdong
Study officials:
References: