Radiofrequency Ablation for Biliopancreatic Malignancy (IGNITE-1)
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ClinicalTrials.gov Identifier: NCT02468076 |
Recruitment Status :
Completed
First Posted : June 10, 2015
Last Update Posted : May 11, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pancreas Cancer Cholangiocarcinoma Obstructive Jaundice | Device: Radiofrequency ablation (StarMed) | Phase 2 |

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 |

Arm | Intervention/treatment |
---|---|
Experimental: Radiofrequency ablation (StarMed)
Radiofrequency ablation catheter
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Device: Radiofrequency ablation (StarMed)
Radiofrequency ablation into bile duct |
- Feasibility (ratio of technically successful RFA-applications to all examinations in which RFA-use was intended) [ Time Frame: 90 days after index procedure ]
- 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 ]
- 30-day-, 90-day and overall mortality [ Time Frame: 90 days after index procedure ]
- Number of days and reasons for hospitalizations during the study period [ Time Frame: 90 day after index procedure ]
- 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 ]
- safety (number and type of adverse events) [ Time Frame: 90 days after index procedure ]

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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:
- Male or female subjects with age above 18 years old
- A confirmed diagnosis (endoscopic radiology, histology etc) of pancreatic or cholangiocarcinoma with obstructive jaundice considered inoperable according to multidisciplinary assessment
- Willing and able to give written informed consent
Exclusion Criteria:
- Refusal to consent or undergo ERCP
- Less than 50% of liver parenchyma potentially drainable on pre-intervention imaging
- Platelets < 40 x 109 mm3, an international normalized ratio (INR) > 1.5
- Other concomitant disease or condition likely to significantly decrease life expectancy (e.g., moderate to severe congestive heart failure, severe COPD)
- Portal vein thrombosis
18 patients to be included : Hilar cholangiocarcinoma : n=9 Distal cholangiocarcinoma/pancreatic cancer n=9

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
Belgium | |
University Hospitals Leuven | |
Leuven, Brabant, Belgium, 3000 |
Principal Investigator: | Laleman Wim, MD PhD | Universitaire Ziekenhuizen Leuven |
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 |
ERCP radiofrequency ablation obstructive jaundice |
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 |