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 | Unknown DMC

• 1 other identifier: 274029
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Recruitment Rate

  The average number of participants consented per month.

  12 months

Secondary Outcomes (15)

• Retention rate

  12 months

• Assessment Adherence

  12 months

• Intervention free survival

  12 months

• Overall survival

  12 months

• Stent Patency

  12 months

Other Outcomes (6)

• Resource Use - Operative Room Time

  During Procedure

• Resource Use - Admission Length

  During admission, expected within range Day -7 to Day +14

• Resource Use - Hospital Recovery Time

  During admission, Day 0 up to Day +14 (expected)

Study Arms (2)

Intervention

EXPERIMENTAL

Biliary stenting plus radio-frequency ablation of the bile duct

Procedure: Intraductal Radio-Frequency Ablation; Device: Biliary Stent Placement

Control

ACTIVE COMPARATOR

Biliary stenting alone

Device: Biliary Stent Placement

Interventions

Intraductal Radio-Frequency Ablation PROCEDURE

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.

Intervention

Biliary Stent Placement DEVICE

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

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18-85 years;
• A cytological/histological or radiological diagnosis of inoperable HPB malignancy;
• MDT review confirming inoperability.
• Patients who have declined surgery will also be considered for the study.
• Medically fit to undergo procedure in opinion of the investigator.

You may not qualify if:

• Unable to provide free informed consent within 7 days;
• ECOG performance status 3 or 4;
• Life expectancy \<1 months;
• Prior investigational drugs within last 30 days;
• \- Patients who have already commenced approved chemotherapy regimens are not excluded from the study.
• Patients with clinically significant ascites;
• Patients with CNS metastases;
• Major surgery within last 30 days;
• Patients with active sepsis or encephalopathy;
• Evidence of spontaneous bacterial peritonitis or renal failure;
• Pregnant or lactating women;
• \- Females of childbearing potential will undergo a blood pregnancy test to confirm they are not pregnant within 7 days prior to randomisation.
• Unstable angina, heart disease or diabetes;
• Intractable severe blood coagulation dysfunction;
• Fitted with implantable pacemaker, implantable cardioverter/defibrillator or other active implant;

Sponsors & Collaborators

• University Hospitals Dorset NHS Foundation Trust: lead
• The Christie NHS Foundation Trust: collaborator

Study Sites (2)

Royal Bournemouth Hospital

Bournemouth, Dorset, BH7 7DW, United Kingdom

RECRUITING

The Christie

Manchester, M20 4BX, United Kingdom

NOT YET RECRUITING

Related Links

• Related Info

Central Study Contacts

Clare Bent

CONTACT

01202 303626; clare.bent@uhd.nhs.uk

Sponsor

CONTACT

researchsponsorship@uhd.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: June 28, 2021
• Study Start: September 16, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: May 11, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)