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

NCT06447181 | Not Yet Recruiting DMC

• 1 other identifier: 2023-KY-122-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatolithiasis; Hepatectomy

Keywords

Three-dimensional visualization; ICG; hepatolithiasis

Outcome Measures

Primary Outcomes (3)

• operation time

  minutes

  Perioperative period

• intraoperative blood loss

  ml

  Perioperative period

• intraoperative incidental injuries

  Perioperative period

Secondary Outcomes (3)

• Postoperative complications

  Perioperative period

• Repeat surgery rate

  Perioperative period

• Serum bilirubin levels

  Perioperative period

Study Arms (2)

3DVT-FI Group

Patients with hepatolithiasis using 3D visualization combined with ICG fluorescence technique

Device: 3D visualization technology ; ICG fluorescence technology .

Conventional operation Group

Patients with hepatolithiasis using conventional operation

Interventions

3D visualization technology ; ICG fluorescence technology . DEVICE

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.

3DVT-FI Group

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital

Guangzhou, Guangdong, 510280, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: June 7, 2024
• Study Start: August 30, 2024
• Primary Completion: December 25, 2024
• Study Completion: December 30, 2024
• Last Updated: June 7, 2024

Record last verified: 2024-04

Locations

CN (1)