DRAGON-2
Huidige inclusies:
60/348 (17%)
Doel:
Vergelijken van gecombineerde portale en hepatische vene embolisatie (PVE/HVE) met portale vene embolisatie (PVE) bij colorectale levermetastasen
Samenvatting:
An International Multicenter Randomized Controlled Trial to Compare Combined Portal and Hepatic Vein Embolization (PVE/HVE) with PVE Alone in Patients with Colorectal Liver Cancer Metastases (CRLM) and a Small Future Liver Remnant (FLR)
Resection of liver metastases from colorectal cancer (CRLM) improves survival compared to chemotherapy alone and may lead to cure in up to 40% of patients. Extended liver resections are sometimes necessary to resect primarily unresectable/ potentially resectable (PU/PR) colorectal liver metastases. These resections are generally performed if the volume of the future liver remnant (FLR) comprises at least 30% of the total volume of the liver (without the volume of the metastases) or when liver function of the FLR on technetium-99m (99mTc) scintigraphy exceeds 2.67%/min/m2.
When this liver volume or function criterion is not met, a high chance of post-hepatectomy liver failure exists. To prevent this, the induction of liver regeneration between a two-stage hepatectomy is commonly performed.
The current standard procedure to induce regeneration is the embolization of the portal vein branches to the tumor carrying liver (PVE) to induce hypertrophy of the remaining part of the liver which will serve as the FLR. Recently, combined embolization of both portal and hepatic veins (PVE/HVE) has been described as a possible superior alternative to PVE, as it increases and accelerates hypertrophy of the FLR. PVE/HVE combines simultaneous embolization of the main portal vein branches into the tumor carrying liver and the hepatic vein draining this part of the liver. Preclinical studies in pigs, several retrospective studies, and the prospective DRAGON 1 interim analysis (n=60) have demonstrated the safety and feasibility of this novel technique. However, no international randomized controlled trial has been performed, in which combined PVE/HVE is compared with PVE
Primaire uitkomst:
FLR volume of functie sufficient voor resectie 3 weken na embolisatie
FLR:
- ≥30% in normally functioning livers
- ≥40% in livers with potentially impaired function
- ≥50% in livers with severely impaired function resulting from liver cirrhosis OR for any FLR volume
- Function on hepatobiliary scintigraphy is > 2.69 %/min/m2
Secundaire uitkomsten:
Intervention effect
- Kinetic growth rate
- FLR function increase
- Time to sufficient FLR volume
- Salvageprocedure rate
- Post-embolization complications
Resection-related
- Time from intervention to resection
- Clinical resectability
- Intra/post-operative complications (incl. PHLF rate)
- Blood loss
- 90d mortality
- Composite: resected with 90-day survival
- Inflammation/fibrosis/cirrhosis at histology
Oncological and long-term
- 3y survival
- Recurrence rate
- 5y progression-free survival
- No. & type of oncological interventions during survival
- Cause of death
- Quality of life
- Costs
Ontwerp:
Multicenter prospectieve interventionele studie
Duur:
Inclusiecriteria:
Patients with CRLM and insufficient FLR volume/function
-
FLR volume:
- <30% in normally functioning livers
- <40% in livers with potentially impaired function - FLR function <2.69%/min/m2, measured using HEBIS
18 years and older
Exclusiecriteria:
- Prohibitive comorbidities
- Hepatic malignancies other than CRLM
- Progression of disease by RECIST after cytoreduction chemotherapy
- PVE/HVE anatomically not feasible
National Clinical Trial (NCT) nummer:
NCT05428735
