Clinical trial NCT01666145: Advanced Image Guidance Utilized in Liver Surgery
Official title: Advanced Image Guidance for Ablation Probe Placement in Laparoscopic Liver Surgery: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carcinoma, Hepatocellular
Keywords: Hepatocellular Cancer
Hepatocellular Carcinoma
Hepatoma
Liver Cancer, Adult
Liver Cell Carcinoma, Adult
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: InnerOptic
First posted: 2012-08-16
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Successful Insertion of Ablation Antenna Into Target Lesion
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 to 3 days.
Secondary outcomes:
measure: Percentage of Participants With Significant Ease of Lesion Targeting Using Advanced Image Guidance (AIM)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 to 3 days.
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Health System
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: David A Iannitti, MD
role: PRINCIPAL_INVESTIGATOR
References: