Feasibility of a Minimally Invasive Image-Guided Surgery System for Hepatic Procedures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pathfinder Therapeutics
ClinicalTrials.gov Identifier:
NCT01237990
First received: November 8, 2010
Last updated: January 19, 2012
Last verified: January 2012
  Purpose

This study was designed to confirm that the surgeon is able to perform surface registration of standard liver features used as landmarks during a scheduled laparoscopic liver procedure. Additionally, registrations will be obtained with full insufflation pressure and with half insufflation pressure during the laparoscopic procedure. Under the presence of both insufflation pressures, the surface of the liver will be manually swabbed with the study tracked laparoscopic probe with landmarks noted during data collection. After registration of the liver is obtained, the registration points obtained during this procedure will be evaluated by the surgeon by moving the tracked laparoscopic probe over the liver surface and evaluating the location of the tracked laparoscopic probe displayed on the guidance system 3D image. The surgeon will accept or reject the registration accuracy. Upon completion of the scheduled laparoscopic procedure, the subject will then undergo the open procedure scheduled for the surgical case. An open liver registration will be obtained with manual swabbing of the liver using the study tracked probe and will be accepted or rejected by the surgeon using the process described in the laparoscopic procedure.

In the event that the disease is determined to be too great for surgical repair during the laparoscopic staging procedure, only minimally invasive liver surface data will be acquired and the patient will not be included in the overall study population.


Condition
Liver Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Feasibility of a Minimally Invasive Image-Guided Surgery System for Hepatic Procedures

Resource links provided by NLM:


Further study details as provided by Pathfinder Therapeutics:

Primary Outcome Measures:
  • The number of accepted liver registrations associated with laparoscopically acquired surface data compared with the number of accepted liver registrations associated with open liver acquired surface data. [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
    Subjects are followed for the study 30days (+/- 14 days) and are considered to have completed the study following this 30 day follow-up visit.


Secondary Outcome Measures:
  • Comparison of registration errors from the full and half sufflation pressures to determine an impact of insufflation pressure on registration accuracy. [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
    Subjects are followed for the study up to 30days (+/- 14 days) and are considered to have completed the study following this 30 day follow-up visit.


Enrollment: 20
Study Start Date: August 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Detailed Description:

The Pathfinder System used during this study is used for data collection purposes only and is not used during the surgical procedure as an image guided system.

Preoperative CT scans, obtained as standard of care, will be used to generate the image guided liver system 3D liver surface images used during the study.

During the laparoscopic procedure, the Pathfinder device will be inserted through the standard laparoscopic ports (5mm or 10mm) being used for the staging procedure.

For the purposes of the study, subjects will be enrolled following the inclusion/exclusion criteria below:

Inclusion:

  1. Written informed consent must be obtained.
  2. Patients enrolled must be undergoing a staging laparoscopy for with the intention for conversion to laparotomy.
  3. Patient must be 18 years of age or older.
  4. Women of childbearing age without documented evidence of menopause or sterility must have a negative serum or urine pregnancy test at the time of screening.

Exclusion:

  1. Any condition which, in the judgement 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.
  2. Patients that have a condition rendering them unable to understand the nature, scope and possible consequences of this study and therefore unable to give proper consent.
  3. Patients with Cirrhosis of the liver classified as Child-Pugh B or C.
  4. Patients undergoing liver surgery for the purpose of receiving a liver transplant.
  5. Patients with established renal insufficiency (defined as creatinine greater than 2.5 mg/dl), or a condition that requires hemodialysis.

A total study population will include 20 subjects that complete both the laparoscopic and open liver procedures scheduled.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Any subject with liver cancer scheduled for a laparoscopic staging and open liver resection procedure.

Criteria

Inclusion Criteria:

  • Clinical Diagnosis of Liver Cancer
  • Scheduled for liver surgery

Exclusion Criteria:

  • Receiving a liver transplant
  • Kidney failure or dialysis
  • Unable to consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01237990

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Pathfinder Therapeutics
Investigators
Principal Investigator: William Jarnagin, M.D. Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Pathfinder Therapeutics
ClinicalTrials.gov Identifier: NCT01237990     History of Changes
Other Study ID Numbers: PTI-LC-2009-01
Study First Received: November 8, 2010
Last Updated: January 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Pathfinder Therapeutics:
liver
cancer
tumor

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on September 18, 2014