Clinical trial · Interventional
Feasibility of Ultrasound-based Navigation for Non-anatomical Liver Resections
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulties with recruiting participants for the study due to the COVID-19 pandemic.
Summary
Brief summary (as posted)
In a non-anatomical resection of a liver tumor, only the part of the liver with the tumor and a safety margin of 5 - 10 mm are resected. This is done to ensure a negative resection margin, which means that no tumor cells are at the boundary of the resection. These non-anatomical resections can be performed repeatedly in case of recurrence. However, compared to anatomical resections, it is more challenging to keep a negative resection margin as anatomical landmarks cannot be used for intra-operative guidance. In this study, the investigators aim to clinically evaluate a 3d navigation system, where navigated intra-operative ultrasound data is used to create a virtual model and a surgical plan.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Neoplasm | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic image-guided resection | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- Stereotactic image-guided non-anatomical resection
- interventionNames
- Device: Stereotactic image-guided resection
Primary outcomes (1)
- measure
- R0 resection rate
- timeFrame
- 30 days
- description
- Assessed by histopathological examination of the resected specimen. R0 is defined as a negative resection margin of \>1 mm.
Secondary outcomes (8)
- measure
- Number of re-resections
- timeFrame
- intra-operative, expected to be up to 4 hours
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients which are regularly scheduled for an open surgical liver resection * At least one tumor considered for non-anatomical resection * Lesion is visible on ultrasound imaging * Informed Consent as documented by signature (Appendix Informed Consent Form) * Age \>= 18 years Exclusion Criteria: * Other clinically condition or disease that would (as deemed by the operating surgeon) significantly increase the risk of surgery * Lesion is close to major vessel (\< 10 mm) * Lesion is too large to be visualized on ultrasound imaging * Emergency * Subjects not able to give informed consent (dementia) * Women of childbearing potential (less than 1 year post-menopausal)
References
Publications (4)
- BACKGROUNDMoris D, Tsilimigras DI, Kostakis ID, Ntanasis-Stathopoulos I, Shah KN, Felekouras E, Pawlik TM. Anatomic versus non-anatomic resection for hepatocellular carcinoma: A systematic review and meta-analysis. Eur J Surg Oncol. 2018 Jul;44(7):927-938. doi: 10.1016/j.ejso.2018.04.018. Epub 2018 Apr 30. PMID 29751946
- BACKGROUNDBanz VM, Muller PC, Tinguely P, Inderbitzin D, Ribes D, Peterhans M, Candinas D, Weber S. Intraoperative image-guided navigation system: development and applicability in 65 patients undergoing liver surgery. Langenbecks Arch Surg. 2016 Jun;401(4):495-502. doi: 10.1007/s00423-016-1417-0. Epub 2016 Apr 28. PMID 27122364
- BACKGROUNDLango T, Vijayan S, Rethy A, Vapenstad C, Solberg OV, Marvik R, Johnsen G, Hernes TN. Navigated laparoscopic ultrasound in abdominal soft tissue surgery: technological overview and perspectives. Int J Comput Assist Radiol Surg. 2012 Jul;7(4):585-99. doi: 10.1007/s11548-011-0656-3. Epub 2011 Sep 3. PMID 21892604
- BACKGROUNDKingham TP, Jayaraman S, Clements LW, Scherer MA, Stefansic JD, Jarnagin WR. Evolution of image-guided liver surgery: transition from open to laparoscopic procedures. J Gastrointest Surg. 2013 Jul;17(7):1274-82. doi: 10.1007/s11605-013-2214-5. Epub 2013 May 4. PMID 23645420