Study of Saline Linked Monopolar Surface Radiofrequency (RF) Ablation of Hepatic Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00869843
First received: March 25, 2009
Last updated: April 22, 2013
Last verified: April 2013
  Purpose
  • To determine the depth of coagulation which is possible in human liver tissue using the saline linked RF Surface ablation with the Tissue Link floating ball.
  • To determine the efficacy of the technique on surface liver tumors using saline linked RF surface ablati
  • To determine a safe (non-popping upper limit) of power per area that will permit a 1 cm depth of tissue destruction without inflow occlusion an da 2 cm depth with inflow occlusion.

Condition Intervention Phase
Malignant Liver Tumors
Liver Metastases From Colorectal Cancer
Procedure: RF Ablation
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Saline Linked Monopolar Surface Radiofrequency (RF) Ablation of Hepatic Tumors

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Depth of coagulation which is possible in human liver tissue using the saline linked RF Surface ablation with the Tissue Link floating ball [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    On day of surgery

  • Efficacy of the technique on surface liver tumors using saline lined RF Surface ablation. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    On day of surgery


Secondary Outcome Measures:
  • Determine a safe (non-popping upper limit) of power per area that will permit a 1 cm depth of tissue destruction without inflow occlusion and a 2 cm depth with inflow occlusion. [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    On day of surgery


Enrollment: 28
Study Start Date: October 2002
Study Completion Date: March 2009
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single group Procedure: RF Ablation

Detailed Description:

Treatment Plan: Patients with resectable hepatic metastases confined to the liver and who are referred to the Study Chairs will undergo routine work-up for hepatic resection.

Operative Procedure:

Stage I will be completed and the data analyzed before Stage II commences. Stage I data will be used to define the safe levels for use in Stage II.

Stage I—Depth of coagulation with and without inflow occlusion at fixed times - and powers below the popping threshold.

At surgery, in the absence of extrahepatic disease, the liver will be dissected in the usual fashion for a bi-segmentectomy, hemihepatectomy or larger liver resection. Prior to transection of the liver, saline linked RF ablations will be performed on normal liver tissue within the area of resection away from the tumor and the proposed line of transection.

1 cm and 2 cm diameters will be studied together in 8 patients. They will be treated for a total of 18 minutes (9 min for 1 cm and 9 min for 2 cm with 9 minutes of inflow occlusion. The 4 cm lesions will be studied in 8 other patients, 4 of whom will receive 9 minutes of inflow occlusion.

After resection of the liver and establishment of resection margins on the tumor, the ablated areas of normal liver tissue will be excised frozen and studied for depth of lesion and examined by H & E and histological techniques using vital stains that will allow definition of tissue depth.

Stage II—An ablate and resect Study

Once parameters have been defined on normal liver, the effect of surface RF ablation on resectable hepatic tumors which come to the surface of the liver will be examined. In this portion of the study, tumors will be treated with saline linked RF ablation with a power and a duration of application which has been found to produce the maximum safe depth of coagulation. The surface area of coagulation will be dependent upon the size of the tumor. The area of treatment will encompass the tumor as well as a zone at least 0.5cm outside the edge of the tumor. Inflow occlusion will be used in one half of the patients.

After resection of the liver and establishment of resection margins on the tumor, the ablated areas will be excised frozen and studied for depth of lesion and examined by H & E and histological techniques using vital stains that will allow definition of tissue depth. Twelve tumors will be treated in 12 patients.

Pathology Evaluation

First Group of Patients The normal tissue exposed to RF will be resected, prepared for histo-pathological studies and examined to determine the extent of tissue necrosis and popping, if any.

Second Group of Patients Tumors exposed to RF ablation will be resected and the extent of tissue necrosis and popping will be determined. Also, damage to normal tissue will be examined.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Eligibility for Stage I (Normal Liver Tissue)

  • Resectable liver metastases from malignant liver tumors, primary or secondary
  • Patient has been scheduled for liver resection and is in generally good medical condition
  • No evidence of extra-hepatic disease
  • Patient does not have a pacemaker
  • Age >= 18
  • Able to provide informed consent

Eligibility for Stage II (Patients with liver metastases from colorectal cancer)

  • Resectable liver metastases from colorectal cancer
  • Patient has been scheduled for liver resection is in generally good medical condition
  • No evidence of extra-hepatic disease.
  • Patient does not have a pacemaker
  • Age >= 18
  • Able to provide informed consent
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00869843

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Steven Strasberg, M.D. Washington University School of Medicine
  More Information

Additional Information:
No publications provided by Washington University School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00869843     History of Changes
Other Study ID Numbers: 02-0343
Study First Received: March 25, 2009
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Metastatic colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Liver Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Liver Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on July 26, 2014