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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.

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ClinicalTrials.gov Identifier: NCT04941924
Recruitment Status : Not yet recruiting
First Posted : June 28, 2021
Last Update Posted : September 14, 2021
Sponsor:
Collaborators:
Aquilant Services
The Christie NHS Foundation Trust
Information provided by (Responsible Party):
University Hospitals Dorset NHS Foundation Trust

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.


Condition or disease Intervention/treatment Phase
Malignant Biliary Obstruction Procedure: Intraductal Radio-Frequency Ablation Device: Biliary Stent Placement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: A Pilot Multicentre Prospective Randomised Controlled Trial Comparing the Safety and Efficacy of Intraductal Radio-frequency Ablation (ID-RFA) Using Starmed's Temperature Controlled ELRA™ Probe Plus Biliary Stenting Versus Biliary Stenting Alone for the Treatment of Malignant Biliary Obstruction.
Estimated Study Start Date : October 2021
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Arm Intervention/treatment
Experimental: Intervention
Biliary stenting plus radio-frequency ablation of the bile duct
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.

Active Comparator: Control
Biliary stenting alone
Device: Biliary Stent Placement
Taewoong Niti-S™ LCD Biliary stents (CE marked uncovered self-expanding metal stents) placed according to standard local practice.




Primary Outcome Measures :
  1. Recruitment Rate [ Time Frame: 12 months ]
    The average number of participants consented per month.


Secondary Outcome Measures :
  1. Retention rate [ Time Frame: 12 months ]
    The percentage of overall patients who consent to the trial and are not withdrawn either by their own choice or clinicians. Death does not constitute withdrawal.

  2. Assessment Adherence [ Time Frame: 12 months ]
    The percentage of protocol defined assessments completed in accordance with the protocol for patients who are alive and remain within the study at that point.

  3. Intervention free survival [ Time Frame: 12 months ]
    The time in days between receiving the intervention and either repeated stenting due to occlusion or death.

  4. Overall survival [ Time Frame: 12 months ]
    The number of days from receiving the intervention to patient death.

  5. Stent Patency [ Time Frame: 12 months ]
    The number of days from the procedure to Stent Occlusion confirmed by imaging or biochemistry (blood tests).

  6. Increase in ductal caliber following intervention [ Time Frame: Day 0 ]
    Determined by comparison of imaging collected during the index procedure pre intervention and following both RFA for the experimental arm, and following stent placement for both arms. This will be measured at the narrowest stricture point.

  7. Restoration of Biliary flow following intervention as determined by imaging during procedure [ Time Frame: Day 0 ]
  8. Rates of cholangitis related to stent dysfunction [ Time Frame: 12 months ]
    The percentage of patients who experience such an event.

  9. EQ-5D-5L quality of life questionnaire [ Time Frame: Pre procedure, and at 1 week and 1, 2, 3, 6 and 12 months post procedure. ]
    Participants will be asked to complete the EQ-5D-5L quality of life questionnaire, and index value calculated according to the user guide.

  10. QLQ-C30 quality of life questionnaire [ Time Frame: Pre procedure, and at 1 week and 1, 2, 3, 6 and 12 months post procedure. ]
    Participants will be asked to complete the QLQ-C30 quality of life questionnaire including an module determined by cancer type; QLQ-BIL21 (Cholangiocarcinoma and Gallbladder Cancer), QLQ-HCC18- (Hepatocellular Carcinoma) or QLQ-PAN26 (Pancreatic Cancer).

  11. Symptom Score [ Time Frame: Pre procedure, and at 1 week and 1, 2, 3, 6 and 12 months post procedure. ]
    Participants will be assessed for jaundice, nausea, bloating and abdominal pain, if present this will be graded according to CTCAE v5.0 criteria.

  12. Serum bilirubin (in μmol/L) [ Time Frame: At baseline, within 24 hours before the procedure, within 24 hours after, and at 1 week and 1, 2, 3, 6 and 12 months post procedure. ]
  13. Alkaline phosphatase (in iu/L) [ Time Frame: At baseline, within 24 hours before the procedure, within 24 hours after, and at 1 week and 1, 2, 3, 6 and 12 months post procedure. ]
  14. Alanine transaminase (in iu/L) [ Time Frame: At baseline, within 24 hours before the procedure, within 24 hours after, and at 1 week and 1, 2, 3, 6 and 12 months post procedure. ]
  15. International normalized ratio [ Time Frame: At baseline, within 24 hours before the procedure, within 24 hours after, and at 1 week and 1, 2, 3, 6 and 12 months post procedure. ]
    Calculated from prothrombin time,


Other Outcome Measures:
  1. Resource Use - Operative Room Time [ Time Frame: During Procedure ]
    This will be recorded from when the patient first enters the radiology or endoscopy room to the time that they leave. This will be used to make an assessment of facility and staff costs.

  2. Resource Use - Admission Length [ Time Frame: During admission, expected within range Day -7 to Day +14 ]
    The total time that the patient is admitted for the procedure including recovery and prolonged admission due to complications. This will be used to make an assessment of facility and staff costs.

  3. Resource Use - Hospital Recovery Time [ Time Frame: During admission, Day 0 up to Day +14 (expected) ]
    The total time that the patient is admitted from procedure completion to full discharge. This will be used to make an assessment of facility and staff costs.

  4. Resource Use - Quantity and details of single use devices and non-medicinal supplies utilised during procedure [ Time Frame: During procedure ]
    Any single use items used in the procedure will be recorded including; RFA catheter, balloon catheter, stents and any other ancillary supplies. This will be used calculate the cost of the equipment used in the procedure.

  5. Resource Use - Medication Usage (name, dosage, frequency and duration of) [ Time Frame: During admission ]
    All medications used during the patient admission including prophylactic medication and that used to manage any adverse events. This may include parenteral fluids and blood products. Any medication that the participant routinely received prior to entry to the trial will be not be included. This will be used calculate the cost of the medication administered during admission.

  6. Resource Use - Subsequent healthcare attendances (type, number and duration of) [ Time Frame: through study completion, up to 12 months ]
    Any clinic visits, admissions and subsequent procedures relating to the trial indication or complications of the intervention that the patient undergoes in the 12 month trial period. This will be used to make an assessment of facility and staff costs.



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. Patients 18-85 years;
  2. A cytological/histological or radiological diagnosis of inoperable HPB malignancy;
  3. MDT review confirming inoperability.

    -Patients who have declined surgery will also be considered for the study.

  4. Medically fit to undergo procedure in opinion of the investigator.

Exclusion Criteria:

  1. Unable to provide free informed consent within 7 days;
  2. ECOG performance status 3 or 4;
  3. Life expectancy <1 months;
  4. Prior investigational drugs within last 30 days;

    - Patients who have already commenced approved chemotherapy regimens are not excluded from the study.

  5. Patients with clinically significant ascites;
  6. Patients with CNS metastases;
  7. Major surgery within last 30 days;
  8. Patients with active sepsis or encephalopathy;

    - Patients may present with biliary sepsis prior to diagnosis. Inclusion of such a patient can be considered once biliary sepsis has been managed as per local Trust guidance.

  9. Evidence of spontaneous bacterial peritonitis or renal failure;
  10. 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.

  11. Unstable angina, heart disease or diabetes;
  12. Intractable severe blood coagulation dysfunction;
  13. Fitted with implantable pacemaker, implantable cardioverter/defibrillator or other active implant;
  14. Unable to understand the study information or unable to complete the outcome questionnaires (in English);
  15. Un-willing or un-able to comply with all protocol requirements including scheduled visits, treatment plans, laboratory tests and other study procedures;
  16. Medically un-fit to undergo procedure in opinion of the investigator.

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): NCT04941924


Contacts
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Contact: Clare Bent 01202 303626 clare.bent@uhd.nhs.uk
Contact: Sponsor researchsponsorship@uhd.nhs.uk

Locations
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United Kingdom
Royal Bournemouth Hospital
Bournemouth, Dorset, United Kingdom, BH7 7DW
Contact: Research Office       researchoffice@uhd.nhs.uk   
Principal Investigator: Clare Bent         
The Christie
Manchester, United Kingdom, M20 4BX
Contact: Research and Innovation       the-christie.christie.rand@nhs.net   
Principal Investigator: Damian Mullan         
Sponsors and Collaborators
University Hospitals Dorset NHS Foundation Trust
Aquilant Services
The Christie NHS Foundation Trust
Additional Information:
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Responsible Party: University Hospitals Dorset NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04941924    
Other Study ID Numbers: 274029
First Posted: June 28, 2021    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No