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Radiofrequency Ablation for Biliopancreatic Malignancy (IGNITE-1)

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.
 
ClinicalTrials.gov Identifier: NCT02468076
Recruitment Status : Completed
First Posted : June 10, 2015
Last Update Posted : May 11, 2016
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:
This phase-2 study aims to evaluate feasibility, safety and efficacy of thermal ablation of biliary obstructive malignancies by means of radiofrequency ablation (RFA, ELRA, StarMed) during endoscopic retrograde cholangio-pancreaticography (ERCP) with primary intent to obtain palliative biliary drainage via stenting

Condition or disease Intervention/treatment Phase
Pancreas Cancer Cholangiocarcinoma Obstructive Jaundice Device: Radiofrequency ablation (StarMed) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigation of the Effect of Intraductal Radiofrequency Ablation in Inoperable Biliopancreatic Tumors Complicated With Obstructive Jaundice
Study Start Date : November 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Radiofrequency ablation (StarMed)
Radiofrequency ablation catheter
Device: Radiofrequency ablation (StarMed)
Radiofrequency ablation into bile duct




Primary Outcome Measures :
  1. Feasibility (ratio of technically successful RFA-applications to all examinations in which RFA-use was intended) [ Time Frame: 90 days after index procedure ]

Secondary Outcome Measures :
  1. Efficacy measured by progression-free survival at 3 months upon standard follow-up imaging study and duration of stent patency (days) after the RFA-performed procedure [ Time Frame: 90 days after index procedure ]
  2. 30-day-, 90-day and overall mortality [ Time Frame: 90 days after index procedure ]
  3. Number of days and reasons for hospitalizations during the study period [ Time Frame: 90 day after index procedure ]
  4. Quality of life (QuoL) by means of the EORTC QLQ-C15-PAL questionnaire after the procedure and at 30 and 90 days vs before [ Time Frame: 90 days after index procedure ]
  5. safety (number and type of adverse events) [ Time Frame: 90 days after index procedure ]


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
Criteria

Inclusion Criteria:

  1. Male or female subjects with age above 18 years old
  2. A confirmed diagnosis (endoscopic radiology, histology etc) of pancreatic or cholangiocarcinoma with obstructive jaundice considered inoperable according to multidisciplinary assessment
  3. Willing and able to give written informed consent

Exclusion Criteria:

  1. Refusal to consent or undergo ERCP
  2. Less than 50% of liver parenchyma potentially drainable on pre-intervention imaging
  3. Platelets < 40 x 109 mm3, an international normalized ratio (INR) > 1.5
  4. Other concomitant disease or condition likely to significantly decrease life expectancy (e.g., moderate to severe congestive heart failure, severe COPD)
  5. Portal vein thrombosis

18 patients to be included : Hilar cholangiocarcinoma : n=9 Distal cholangiocarcinoma/pancreatic cancer n=9


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 ClinicalTrials.gov identifier (NCT number): NCT02468076


Locations
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Belgium
University Hospitals Leuven
Leuven, Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Laleman Wim, MD PhD Universitaire Ziekenhuizen Leuven
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02468076    
Other Study ID Numbers: IGNITE-1
First Posted: June 10, 2015    Key Record Dates
Last Update Posted: May 11, 2016
Last Verified: November 2014
Keywords provided by Universitaire Ziekenhuizen Leuven:
ERCP
radiofrequency ablation
obstructive jaundice
Additional relevant MeSH terms:
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Cholangiocarcinoma
Pancreatic Neoplasms
Jaundice
Jaundice, Obstructive
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations