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Advanced Image Guidance Utilized in Liver Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01666145
Recruitment Status : Completed
First Posted : August 16, 2012
Results First Posted : August 27, 2018
Last Update Posted : August 27, 2018
Information provided by (Responsible Party):
David Iannitti, Atrium Health

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Device: Advanced Image Guidance Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Advanced Image Guidance for Ablation Probe Placement in Laparoscopic Liver Surgery: A Pilot Study
Study Start Date : February 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : February 2014

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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. ]
    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.

Secondary Outcome Measures :
  1. Percentage of Participants With Significant 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. ]
    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. The percentage of participants with a score of 5 is reported below.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Individuals who have hepatocellular carcinoma.
  • Individuals who are candidates for microwave ablation surgery.

Exclusion Criteria:

  • Individuals who do not have hepatocellular carcinoma.
  • Individuals who are not a candidate for laparoscopic microwave ablation surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01666145

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United States, North Carolina
Carolinas Health System
Charlotte, North Carolina, United States, 28204
Sponsors and Collaborators
Atrium Health
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Principal Investigator: David A Iannitti, MD Atrium Health
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Responsible Party: David Iannitti, Surgeon, Atrium Health Identifier: NCT01666145    
Other Study ID Numbers: 12-11-13B
First Posted: August 16, 2012    Key Record Dates
Results First Posted: August 27, 2018
Last Update Posted: August 27, 2018
Last Verified: July 2018
Keywords provided by David Iannitti, Atrium Health:
Hepatocellular Cancer
Hepatocellular Carcinoma
Liver Cancer, Adult
Liver Cell Carcinoma, Adult
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases