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Efficacy and survival benefit of Near-Infrared Fluorescence-Guided Hepatectomy for the Detection of Colorectal Liver Metastases: A Multicenter, Prospective, Randomized Controlled Trial

Efficacy and survival benefit of Near-Infrared Fluorescence-Guided Hepatectomy for the Detection of Colorectal Liver Metastases: A Multicenter, Prospective, Randomized Controlled Trial - colorectal cancer; colorectal liver metastasis; fluorescence-guided surgery with NIR; hepatectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073634
Enrollment
Unknown
Registered
2023-07-17
Start date
2023-08-01
Completion date
Unknown
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal liver metastasis

Interventions

Conventional hepatectomy:Conventional hepatectomy
ICG fluorescence imaging guided hepatectomy group:ICG fluorescence imaging guided hepatectomy

Sponsors

The Fifth Affiliated Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) in patients with colorectal cancer diagnosed by pathology, imaging or pathology confirmed synchronous or metachronous liver metastasis; (2) preoperatively, the typical imaging findings of liver metastasis were found in the abdominal MRI with gadolinium chloride disodium, if the abdominal MRI could not be performed Examination, then change to abdominal CT enhancement examination; (3) the liver metastases were evaluated as resectable (R 0 resections for all liver metastases, residual liver volume was larger than standard liver volume after resection 30% of the cumulative total) ; (4) patients with ICG 15 min retention rate < 10% ; (5) age greater than 18 years, less than 75 years, no gender restrictions; (6) tolerance to surgery and general anesthesia, Asa Anesthesia Grade 3 or below, without severe cardio-pulmonary-cerebral disease; (7) those who agree to sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) extrahepatic metastasis and recurrence of liver metastasis; (2) allergic to indocyanine green or iodine; (3) researchers believe that subjects may not be able to complete the study or comply with the requirements of the study (due to administrative reasons or for any other reason) ; (4) the patient's general condition could not tolerate the operation.

Design outcomes

Primary

MeasureTime frame
3 year overall survival rate;—

Secondary

MeasureTime frame
The number of liver metastasis was detected in the two groups;3 years progression-free survival;Postoperative complication rate;—

Countries

China

Contacts

Public ContactLI JIAN

The Fifth Affiliated Hospital, Sun Yat-sen University

lijian5@mail.sysu.edu.cn+86 139 2692 7880

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026