Accuracy Assessment for Computer-assisted Surgical Interventions of the Liver

NCT01474694 | Completed

• 2 other identifiers: 063/11Eureka 6201/5/Ae
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Preoperative image-guided data correlates with the actual intraoperative reality. Computer-assisted preoperative planning combined with intraoperative mapping of even very small lesions allows for improved accuracy during complete oncological resection / ablation. In the short- and long-term this possibly results in better patient outcome.

Conditions

Adult Liver Cancer

Keywords

prospective study; multicenter trial; analysis, computer assisted image; CE marked; medical devices; catheter ablation

Outcome Measures

Primary Outcomes (1)

• TRE, measuring the error in the prediction of a surgical target location when using the navigation system.

  12 months

Secondary Outcomes (1)

• 1.Identification of suitable landmarks for registration

  15 months

Interventions

Abdominal surgery OTHER

The patient is placed in a supine position and standard laparotomy (either via subcostal, midline or inverted hockey-stick incision) is performed. After mobilization of the liver, surgical swabs are packed around the organ to prevent unnecessary movement of the liver during the acquisition of the landmarks and the subsequent surgical procedure

Eligibility Criteria

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

Study Population

patients that are still considered unresectable at the time point of presentation

You may qualify if:

• Written informed consent
• Male patients and non-pregnant, non-lactating females aged ≥18 years of age (negative serum/urine pregnancy test result at screening)
• Patients must be candidates for surgical liver resection and/or MWA (at least one anatomical segment) of primary or metastatic liver cancer. The liver tumors must be present on preoperative imaging study (CT and/or MRI).

You may not qualify if:

• Any condition which, in the judgment of the clinical investigator or his designee, might increase the risk to the subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study.
• A mental condition rendering the patient unable to provide informed consent.
• Patients with hereditary hematological / coagulation disorders unrelated to their liver disease or cirrhosis of the liver classified as Child's B or C.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Dep. of visceral and Transplant Surgery, Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (2)

• Peterhans M, vom Berg A, Dagon B, Inderbitzin D, Baur C, Candinas D, Weber S. A navigation system for open liver surgery: design, workflow and first clinical applications. Int J Med Robot. 2011 Mar;7(1):7-16. doi: 10.1002/rcs.360. Epub 2010 Oct 29.

  PMID: 21341357 BACKGROUND

• Gavaghan KA, Peterhans M, Oliveira-Santos T, Weber S. A portable image overlay projection device for computer-aided open liver surgery. IEEE Trans Biomed Eng. 2011 Jun;58(6):1855-64. doi: 10.1109/TBME.2011.2126572. Epub 2011 Mar 14.

  PMID: 21411401 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Vanessa Banz, Dr. med.

  Bern University Hospital

  PRINCIPAL INVESTIGATOR

• Daniel Candinas, Prof. Dr. med.

  Bern University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 15, 2011
• First Posted: November 18, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 26, 2015

Record last verified: 2015-11

Locations

CH (1)