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Not yet recruitingNCT06447181Updated Jun 7, 2024

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

An observational study in Hepatolithiasis and Hepatectomy, sponsored by Zhujiang Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2024-06-07.

Sponsored by Zhujiang Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
100
Ages
18 Years to 95 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hepatolithiasis
  • Hepatectomy

Keywords

  • Three-dimensional visualization
  • ICG
  • hepatolithiasis
03

In context

Lead sponsor

Zhujiang Hospital is the lead sponsor of 199 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Device3D 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.

06

What researchers measure

Primary outcomes

  1. operation time

    minutes

    Time frame: Perioperative period

  2. intraoperative blood loss

    ml

    Time frame: Perioperative period

  3. intraoperative incidental injuries

    Time frame: Perioperative period

Secondary outcomes

  1. Postoperative complications

    Bile leak, pancreatic leak and stone residue

    Time frame: Perioperative period

  2. Repeat surgery rate

    Time frame: Perioperative period

  3. Serum bilirubin levels

    mmol/L

    Time frame: Perioperative period

07

Study locations

1 site
  • Zhujiang Hospital
    Guangzhou, Guangdong 510280, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06447181
Lead sponsor
Zhujiang Hospital
Responsible party
Sponsor
First posted
Jun 7, 2024
Start date
Aug 30, 2024 (estimated)
Primary completion
Dec 25, 2024 (estimated)
Completion
Dec 30, 2024 (estimated)
Last update
Jun 7, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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