DRAGON I is a pre-trial that aims to introduce PVE/HVE in liver surgery centers worldwide in a controlled fashion to ensuring patient safety, proper data monitoring and a critical assessment of efficacy. The goal of DRAGON 1 is to assemble the…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Demonstrate ability of center to enroll 3 patients in 12 months safely
Secondary outcome
• Efficacy assessment of hypertrophy induced
• Assessment of variety of techniques
- LVD vs. Double vein embolization vs. staged PVE/HVE
• Feasibility assessment (proceeding to resection)
• Safety of PVE/HVE (mortality/ morbidity)
• Oncological effectiveness of PVE/HVE (recurrence/progression
Background summary
Extended hemi-hepatectomies are sometimes used to render initially
nonresectable patients with colorectal cancer liver metastases (CRLM)
resectable after conversion chemotherapy. In order to prevent post hepatectomy
liver failure (PHLF), these resections should only be performed if FLR volume
is at least 30% - 40% of the total volume of the liver, excluding the volume of
the metastases themselves. If FLR volume is not sufficient to allow liver
resection, portal vein embolization (PVE) is now standard treatment to increase
the FLR volume. The downside of PVE is that only between 60-70% of patients end
up with complete tumor resections, largely due to the slow hypertrophy induced,
hesitancy to resect when volume cut-offs are not met and oncological selection
due to early recurrence.
Recently, an alternative method has been introduced to accelerate FLR
hypertrophy. This method became known as Associating Liver Partition and Portal
vein Ligation for staged hepatectomy (ALPPS). It has been shown in a randomized
controlled trial (LIGRO trial) that resection rate in ALPPS is higher than in
PVE. In ALPPS, rapid hypertrophy is induced by transection of the parenchyma
between the FLR and the deportalized lobe and abrogation of collateral flow.
However, functional transection by radiofrequency ablation or banding is also
effective. Recently it was demonstrated that abrogation of the venous outflow
of the deportalized lobe also induces rapid hypertrophy, a method that has been
propagated as *Liver venous deprivation/ Portal and Hepatic vein embolization*.
Such deprivation can be performed by embolizing the portal vein on one side of
the liver and also occlude the outflow veins with umbrellas and glue at the
same side. This simultaneous combination of portal vein embolization and
embolization of the hepatic veins (right and/or middle) has been shown in
patients to accelerate FLR hypertrophy similarly to ALPPS.
In contrast to ALPPS however, the first stage is a radiology intervention only,
similarly to PVE.
Study objective
DRAGON I is a pre-trial that aims to introduce PVE/HVE in liver surgery centers
worldwide in a controlled fashion to ensuring patient safety, proper data
monitoring and a critical assessment of efficacy. The goal of DRAGON 1 is to
assemble the participating centers for DRAGON 2, a future randomized trial of
PVE/DVE vs. PVE.
Study design
Multicenter, international, prospective, multi-center trial to test enrolment
capacity of participants and safety of Portal and Hepatic Vein Embolization
(PVE/HVE): DRAGON 1 will form the basis of a planned subsequent trial (*DRAGON
2*) that will compare PVE with PVE/HVE.
Study burden and risks
We have no evidence that the novel procedure of occluding both portal and
hepatic vein is associated with more risks than the conventional procedure of
occluding only the portal vein. In both procedures, low-grade fevers, pain over
the liver and general exhaustion for a few days have been described.
The new methods of portal vein and hepatic vein occlusion promises to
accelerate growth of the healthy liver. This may result in reducing the waiting
time to surgery. The new method may also the likelihood for participating
patients to have a curative resection to start with.
Universiteitssingel 40
Maastricht 6229 ER
NL
Universiteitssingel 40
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria
• Patients with primarily unresectable/potentially resectable CRLM after
conversion chemotherapy with a FLR <30% in normal livers or 40% in livers
chemotherapy damaged livers. We trust the clinical judgement of teams in the
participating centers to only include those patients who require regenerative
liver surgery and not those that are primarily resectable
• 18 Years and older
• Patients up to ECOG 3 (not more than 50% bedbound)
• Patients with non-resected primary colorectal cancer (CRC) may be included if
and only if there is an intent to remove the CRC after the liver treatment
(liver first approach)
• Staging CT chest and (if symptomatic) CT/MRI brain needs to exclude
unresectable extrahepatic disease, while metastatic disease that may be cured
in the future, is included
• Patients with resectable lung metastases or lung metastases that and be
ablated can be included only after statement about resectability/ablatability
by tumor board
• Patients have to be to understand the trial and provide informed consent.
Exclusion criteria
Exclusion criteria
• Patients with extrahepatic disease other than lung metastases
• Patients with metastatic disease to the lung that cannot be ablated or
resected will be excluded
• Patients with intrahepatic Cholangiocarcinoma (IHCC)
• Patients with Perihilar Cholangiocarcinoma (PHCC)
• Patients with Hepatocellular Carcinoma (HCC)
• Pregnant or lactating women will be excluded. Women in conceiving age are
required to take contraceptives or have to provide documentation of other means
of contraception to be enrolled.
• Progression by modified RECIST criteria on cross-sectional imaging after
conversion chemotherapy is an exclusion criterion.
• Complete response in cross-sectional imaging after conversion chemotherapy,
which is certainly a rare event
Design
Recruitment
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 |
|---|---|
| CCMO | NL71535.068.19 |