NCT02468076

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 10, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

May 11, 2016

Status Verified

November 1, 2014

Enrollment Period

1.3 years

First QC Date

January 5, 2015

Last Update Submit

May 10, 2016

Conditions

Pancreas CancerCholangiocarcinomaObstructive Jaundice

Keywords

ERCPradiofrequency ablationobstructive jaundice

Outcome Measures

Primary Outcomes (1)

  • Feasibility (ratio of technically successful RFA-applications to all examinations in which RFA-use was intended)

    90 days after index procedure

Secondary Outcomes (5)

  • 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

    90 days after index procedure

  • 30-day-, 90-day and overall mortality

    90 days after index procedure

  • Number of days and reasons for hospitalizations during the study period

    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

    90 days after index procedure

  • safety (number and type of adverse events)

    90 days after index procedure

Study Arms (1)

Radiofrequency ablation (StarMed)

EXPERIMENTAL

Radiofrequency ablation catheter

Device: Radiofrequency ablation (StarMed)

Interventions

Radiofrequency ablation (StarMed)DEVICE

Radiofrequency ablation into bile duct

Radiofrequency ablation (StarMed)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven

Leuven, Brabant, 3000, Belgium

Location

Related Publications (1)

  • Laleman W, van der Merwe S, Verbeke L, Vanbeckevoort D, Aerts R, Prenen H, Van Cutsem E, Verslype C. A new intraductal radiofrequency ablation device for inoperable biliopancreatic tumors complicated by obstructive jaundice: the IGNITE-1 study. Endoscopy. 2017 Oct;49(10):977-982. doi: 10.1055/s-0043-113559. Epub 2017 Jul 21.

    PMID: 28732391DERIVED

MeSH Terms

Conditions

Pancreatic NeoplasmsCholangiocarcinomaJaundice, Obstructive

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeJaundiceHyperbilirubinemiaPathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Laleman Wim, MD PhD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2015

First Posted

June 10, 2015

Study Start

November 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

May 11, 2016

Record last verified: 2014-11

Locations

BE(1)