Feasibility of Ultrasound-based Navigation for Non-anatomical Liver Resections

NCT04187937 | Terminated

• 1 other identifier: USGR
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Liver Neoplasm

Keywords

Image-Guidance; Liver Neoplasm

Outcome Measures

Primary Outcomes (1)

• R0 resection rate

  Assessed by histopathological examination of the resected specimen. R0 is defined as a negative resection margin of \>1 mm.

  30 days

Secondary Outcomes (8)

• Number of re-resections

  intra-operative, expected to be up to 4 hours

• Resection margin in mm

  30 days

• Correlation with tumor size

  pre-operative, expected to be up to 30 days

• Correlation with tumor volume

  pre-operative, expected to be up to 30 days

• Correlation with tumor type

  pre-operative, expected to be up to 30 days

Study Arms (1)

Experimental

EXPERIMENTAL

Stereotactic image-guided non-anatomical resection

Device: Stereotactic image-guided resection

Interventions

Stereotactic image-guided resection DEVICE

Stereotactic image-guided resection with an ultrasound-based image-guidance system.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of Bern: collaborator

Study Sites (1)

Department of Visceral Surgery and Medicine, Inselspital, Bern University Hospital, University of Bern

Bern, Switzerland

Location

Related Publications (4)

• Moris 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 BACKGROUND

• Banz 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 BACKGROUND

• Lango 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 BACKGROUND

• Kingham 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 BACKGROUND

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Anja Lachenmayer, MD

  Department of Visceral Surgery and Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-randomized, non-controlled, single-arm feasibility study of intraoperative ultrasound-based navigation for non-anatomical liver resections

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 5, 2019
• Study Start: June 17, 2020
• Primary Completion: February 16, 2022
• Study Completion: February 16, 2022
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)