No registrations found.
ID
Source
Brief title
Health condition
Colorectal liver metastases
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage radical resections
Secondary outcome
Incremental diagnostic accuracy of NIRF imaging
The impact of fluorescent guided resections on surgical patient parameters (eg. Blood loss, operation time)
The short-term (<6 months) oncological outcomes and intrahepatic recurrence rates, with an emphasis on local recurrence at the site of resection. These outcomes will be compared with the Dutch Hepato Biliary Audit (DHBA) data.
Long-term oncological outcomes: overall survival, disease free survival
Background summary
Radical surgical resection is still seen as the ‘gold standard’ and the only potential for cure in patients diagnosed with colorectal liver metastases. Currently 5-year survival rates are between 35-60% in patients undergoing surgery with curative intent. Achieving a radical resection (>1mm) shows superior survival in patients undergoing surgery. Therefore, improving radical resection rates has the potential to improve overall survival rates.
According to data from the Dutch Hepato Biliary Audit, up to 31% of the patients underwent an ‘intention-to-treat’ laparoscopic resection in 2016 in the Netherlands. This is expected to increase in the coming years. During laparoscopy the surgeon is limited in both visible and tactile information for determination of the resection margin of colorectal liver metastases (CRLM). Currently, near infrared fluorescent (NIRF) imaging with ICG is used to determine the resection margin in all participating centres as standard-of-care. Surgeons experience this technique with real-time fluorescent overlay laparoscopy as user friendly, and we have seen promising results so far. Although the fluorescent rim is already used for resection margin assessment, the radical resection rates have not been documented before.
Due to the accumulation of ICG inside immature hepatocytes surrounding the CRLM, a specific fluorescent ‘rim’ is present around the metastasis. Preliminary data show these fluorescent rims are present around all CRLM. Therefore, the use of NIRF imaging during laparoscopic resections of CRLM has the potential to increase radical resection rates.
Study objective
NIRF imaging during minimally invasive resection of liver metastases can aid in achieving higher radical resection rates in patients with colorectal liver metastases.
Study design
Surgery and follow-up
Inclusion criteria
18 years or older
Patients with colorectal liver metastases (primary and recurrent CRLM) planned for curative-intent minimally invasive surgery, either laparoscopic or robotic resection
Patients eligible for indocyanine infusion 24h prior to surgery according to the hospitals protocol
Patients with or without neoadjuvant chemotherapy (for primary and/or secondary colorectal tumor/metastases)
Exclusion criteria
Patients with contraindications for Indocyanine green:
o Iodide allergy of allergies for shells and/or clamps
o Impaired kidney function (eGRF <50)
Local recurrent CRLM at the site of previous ablative therapy
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7674 |
| Other | METC LUMC : G18.115 |