To demonstrate the feasibility of single session minimally invasive concurrent robotic liver resection and cone beam CT-guided percutaneous ablation of colorectal liver metastases in a hybrid operating room and evaluate its outcomes.
ID
Source
Brief title
Condition
- Hepatobiliary therapeutic procedures
- Hepatobiliary neoplasms
- Hepatic and hepatobiliary disorders
Synonym
Research involving
Sponsors and support
Intervention
- Surigical procedure
N.a.
Outcome measures
Primary outcome
<p>The main study endpoint is feasibility of the HARMONY procedure, defined as the technical success of both the robotic surgical resection and C-arm CT-guided ablation within the hybrid operating room. Surgical technical success is defined as treatment according to protocol and full resection of the target lesion confirmed using ICG fluorescence imaging. Ablation technical success is defined as treatment according to protocol and lesion covered completely by the ablation zone, confirmed using ablation confirmation software. </p>
Secondary outcome
<p>Other study parameters include short-term periprocedural outcomes, including morbidity.</p>
Background summary
Surgical resection and ablation offer patients with colorectal liver metastasis (CRLM) the only chance for cure. In select patients with multiple metastases, combined ablation and resection offers the potential for complete hepatic disease clearance, while avoiding the need for extensive liver resections. The current state-of-the-art in liver surgery for CRLM is robotic liver resection with ICG fluorescence imaging. For ablation of CRLM, the gold standard is CT-guided ablation with hepatic arteriography and ablation margin assessment. When both resection and ablation are necessary in the treatment of CRLM, these procedures are typically performed sequentially, leading to two anaesthesia inductions and separate recovery phases. While performing these procedures concurrently could address these drawbacks, it comes with significant technical and logistical challenges. The integrated environment of a hybrid operating room may facilitate the seamless combination of these two procedures in a single session.
Study objective
To demonstrate the feasibility of single session minimally invasive concurrent robotic liver resection and cone beam CT-guided percutaneous ablation of colorectal liver metastases in a hybrid operating room and evaluate its outcomes.
Study design
This study is a prospective observational cohort study in which a novel treatment strategy (single-session robotic liver resection and cone beam CT-guided percutaneous ablation) will be implemented following the IDEAL framework for surgical innovation.
Intervention
Concurrent robotic resection and cone beam CT-guided percutaneous ablation in a hybrid operating room.
Study burden and risks
No additional risks are associated with participation, as combining the procedures is not expected to introduce new risks beyond the known risks inherent to each procedure individually. Perioperative care will occur according to standard practice and no additional data will be gathered rather than the data already collected in the context of the normal clinical routine. Potential benefits of participation are the advantages associated with concurrent procedures including, single anaesthesia induction, shorter total procedure time, and faster recovery.
R.J. Swijnenburg
De Boelelaan 1118
Amsterdam 1081HV
Netherlands
020 444 4444
r.j.swijnenburg@amsterdaumc.nl
R.J. Swijnenburg
De Boelelaan 1118
Amsterdam 1081HV
Netherlands
020 444 4444
r.j.swijnenburg@amsterdaumc.nl
Trial sites in the Netherlands
Listed location countries
Age
Inclusion criteria
Adults (≥18 years of age), eligible for local treatment of colorectal liver metastases using a combination of robotic resection and CT-guided ablation
Exclusion criteria
- Any contraindication for robotic liver resection or CT-guided percutaneous ablation of colorectal liver metastases.
- No informed consent.
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
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 |
|---|---|
| Research portal | NL-009169 |