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.
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Recruitment Rate
研究概览
简要总结
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.
详细描述
This trial will follow a multicentre randomised controlled trial design.
Patients will be recruited by the standard clinical pathway. Patients with these cancers will be under the care of the oncology team, this may be a new referral (fast-track cancer) or ongoing care. If they are symptomatic of potential biliary obstruction (jaundiced) they will undergo an ultrasound and/or CT scan to determine the cause. In the case of fast-track referrals a biopsy will be taken where possible to confirm diagnosis. If these investigations confirm biliary obstruction the case will be referred to the upper gastrointestinal cancer multidisciplinary team for review. In the case of newly diagnosed patients, if the tumour is resectable and the patient is fit for surgery then the patient will be referred to the appropriate surgical team. In newly diagnosed patients the patient may also be referred to the medical oncology team for consideration for chemotherapy or other systemic treatment however this will generally occur after the procedure being studied as such cases are generally 'emergencies' with reliving the obstruction being the most important prognostic factor in the short term.
Patients unsuitable or unwilling for surgery will then be reviewed by the interventional radiology/endoscopy team, either in clinic as an outpatient or on the ward as an inpatient depending on the nature of their case. If as an inpatient this is often performed in conjunction with the oncology team. Treatment options will be discussed with the patient including biliary stenting and at this point the trial will be introduced. The patient will be provided with written information and given the opportunity to ask any questions they may have about the trial. If the original CT imaging does not provide a clear indication of the location of the obstruction the patient will also be referred for magnetic resonance cholangiopancreatography.
Once given sufficient time to consider the study the patient will be reviewed again to make a decision on the course of treatment they would like to take and at this point if willing written informed consent will be taken. The duration of this period will be determined by the nature of the case however adequate time will be given. The results from the previous work-up and any other relevant medical history will be reviewed alongside a clinical assessment a by the investigator to confirm eligibility. This will be entered onto the eCRF prior to randomisation.
Once the patient has been confirmed as eligible and entered into the trial the procedure will be arranged. If the participant is suitable for stenting but not eligible for the trial this will be performed outside the trial. Prior to the procedure blood samples will be collected for Full Blood Count ,liver profile, renal profile and clotting analyses. The participant will also complete two baseline quality of life questionnaires and baseline symptom scores will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
- •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.
- •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;
- •Unable to understand the study information or unable to complete the outcome questionnaires (in English);
- •Un-willing or un-able to comply with all protocol requirements including scheduled visits, treatment plans, laboratory tests and other study procedures;
- •Medically un-fit to undergo procedure in opinion of the investigator.
结局指标
主要结局
Recruitment Rate
时间窗: 12 months
The average number of participants consented per month.
次要结局
- Retention rate(12 months)
- Assessment Adherence(12 months)
- Intervention free survival(12 months)
- Overall survival(12 months)
- Stent Patency(12 months)
- Increase in ductal caliber following intervention(Day 0)
- Restoration of Biliary flow following intervention as determined by imaging during procedure(Day 0)
- Rates of cholangitis related to stent dysfunction(12 months)
- International normalized ratio(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.)
- EQ-5D-5L quality of life questionnaire(Pre procedure, and at 1 week and 1, 2, 3, 6 and 12 months post procedure.)
- QLQ-C30 quality of life questionnaire(Pre procedure, and at 1 week and 1, 2, 3, 6 and 12 months post procedure.)
- Symptom Score(Pre procedure, and at 1 week and 1, 2, 3, 6 and 12 months post procedure.)
- Serum bilirubin (in μmol/L)(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.)
- Alkaline phosphatase (in iu/L)(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.)
- Alanine transaminase (in iu/L)(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.)