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The ID- RFA Trial: A Trial of Intraductal Radio-frequency Ablation (ID-RFA) Plus Biliary Stenting Versus Biliary Stenting Alone for the Treatment of Malignant Biliary Obstruction.

NCT04941924 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-05-11

No results posted yet for this study

Summary

Cancers of the liver, pancreas and gall bladder can partially or fully block the bile duct leading to jaundice. Where these tumours are inoperable, maintaining adequate bile duct drainage is an important factor in survival, both as jaundice itself can ultimately be fatal and because and because it can prevent the administration of chemotherapy. The current standard care is the placement of a stent and possible manual 'trawling' in an attempt to clear the blockage. But these stents often become blocked by tumour ingrowth requiring reintervention. However it may not be safe to do so at this point.

Intraductal radiofrequency ablation (IDRFA) uses heat energy both to 'necrose' the tumour tissue in attempt to slow ingrowth in the channels before inserting stents and to clear blocked stents. There is some evidence that this increases the length of time for the stents to become blocked or with secondary benefits to quality of life and survival however long term data from within the NHS setting is lacking. A full trial is not currently feasible therefore a pilot study is to be conducted to help inform the design of a full trial.

This study will randomise patients attending with malignant biliary obstruction in a 1:1 ratio to receive either intraductal radiofrequency a. Participants will be recruited through the standard clinical pathway (i.e it will be offered to all potentially eligible patients) over a period of 12 months. Participants will be monitored for a period of up to 12 months for survival, stent blockage, symptoms, resource use, quality of life and adverse reactions.

The study will be conducted between Royal Bournemouth Hospital and The Christie, both cancer care centres experienced in the management of these conditions, stent placement and radiofrequency ablation.

Conditions

  • Malignant Biliary Obstruction

Interventions

PROCEDURE

Intraductal Radio-Frequency Ablation

The electrode employed in this study is the STARmed ELRA™ (Endo Luminal Radiofrequency Ablation) electrode; this is a CE marked device. The selected electrode will be connected to the VIVA™ Combo generator (also a CE marked device) and advanced over the guide wire. The power of the generator should be set at either 7 or 10 W depending on the electrode used per manufacturer instructions. An ablation should then be applied at a temperature of 70 to 80℃ for 2 minutes. For longer length strictures or stent occlusions, the RFA probe is withdrawn from proximal to distal in a step by step fashion in respect to the access method used.

DEVICE

Biliary Stent Placement

Taewoong Niti-S™ LCD Biliary stents (CE marked uncovered self-expanding metal stents) placed according to standard local practice.

Sponsors & Collaborators

  • The Christie NHS Foundation Trust

    collaborator OTHER

  • University Hospitals Dorset NHS Foundation Trust

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-16
Primary Completion
2023-10-31
Completion
2023-10-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04941924 on ClinicalTrials.gov