Advanced Image Guidance Utilized in Liver Surgery
Advanced Image Guidance for this study was used during laparoscopic microwave ablation surgery to help the surgeon accurately place the ablation needle into the tumor of patients diagnosed with liver cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Advanced Image Guidance for Ablation Probe Placement in Laparoscopic Liver Surgery: A Pilot Study|
- Successful insertion of ablation antenna into target lesion [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 to 3 days. ] [ Designated as safety issue: Yes ]Once the ablation antenna has been placed into the target lesion, the success or failure of the attempt will be confirmed with conventional ultrasound alone, in two planes. If the placement is deemed successful, the surgeon will commence the ablation of the tumor. If the placement is deemed insufficient, the probe will be removed and another placement will be attempted using conventional guidance.
- Ease of lesion targeting using Advanced Image Guidance (AIM) [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 to 3 days. ] [ Designated as safety issue: No ]A subjective grading scale from which the surgeon will provide the relative ease of lesion targeting using Advanced Image Guidance (AIM) and the guidance system; the scale will be numbered 1-5 with one being significantly difficult and five being significantly easy. In addition, the time to insertion of the probe to lesion targeting in seconds will be recorded for each attempted targeting.
|Study Start Date:||February 2012|
|Study Completion Date:||February 2014|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: Intraoperative Imaging
Laparoscopic microwave ablation surgery utilizing the Advanced Image Guidance system for needle placement.
Device: Advanced Image Guidance
Patients with hepatocellular carcinoma will be treated through laparoscopic microwave ablation surgery, in which the surgeon will utilize a new guidance system for needle placement.
Other Name: AIM
Hepatocellular carcinoma (HCC) is diagnosed in over 19,000 Americans annually and responsible for 17,000 deaths. Worldwide, (HCC) is the third leading cause of cancer death. Hepatocellular carcinoma recurs frequently due to its multi-centric nature, which requires repeated treatments and often results in progressively fewer treatment options because of severe underlying liver dysfunction. While surgery offers the best prognosis for such tumors and lesions, only 10-15% of all patients are candidates for removal by surgical means, necessitating the exploration of other treatment options. InnerOptic's AIM Guidance System is designed to alleviate the difficulty in using ultrasound to place a needle. AIM shows the needle and the ultrasound slice in their locations in 3D on a stereo monitor, making the spatial relationship between them obvious. AIM also displays the needle trajectory and where the needle will intersect with the ultrasound image, providing the surgeon with an indication of where the needle will go, if inserted along the needle shaft. AIM can also render an ablation volume guide, providing the surgeon with further confirmation that the needle is placed accurately and providing a volumetric guide regarding the power settings of the ablation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01666145
|United States, North Carolina|
|Carolinas Health System|
|Charlotte, North Carolina, United States, 28204|
|Principal Investigator:||David A Iannitti, MD||Carolinas Healthcare System|