NCT06990659招募中不适用
CHOC - Implementation and Evaluation of an Ambulatory Care Pathway for Intra-arterial Treatment of Primary Liver Cancer: Study Protocol for a Multicentre Randomised Controlled Hybrid Type 1 Trial Implémentation et évaluation d'un Parcours de Soin Ambulatoire Pour Les Patients traités Par Voie Intra-artérielle d'un Cancer Primitif du Foie : Essai Multicentrique contrôlé randomisé
University Hospital, Angers35 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2025年12月18日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 206
- 试验地点
- 35
- 主要终点
- Overall patient satisfaction
研究概览
简要总结
Randomized multicentre trial comparing two care organisations (ambulatory vs conventional inpatient) for patients undergoing transarterial chemoembolization (TACE) or radioembolization (TARE) for primary liver cancer (Hepato Cellular Carcinoma (HCC) or intrahepatic cholangiocarcinoma (iCCA)). Patients are followed for 7 months to assess patient satisfaction, safety and clinical outcomes. A qualitative implementation study and a medico-economic evaluation (cost analysis and 5-years budget impact analysis) are embedded to assess acceptability, adoption, feasability, and sustainability and to inform scaling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Age ≥ 18 years
- •HCC or iCCA diagnosed according to the criteria of the European Association for the Study of the Liver (2024) or histologically proven.
- •Patient with HCC or iCCA eligible for intra-arterial treatment (transarterial chemoembolization [TACE] or transarterial radioembolization [TARE]), with no prior intra-arterial treatment of the same type as the one planned in the trial:
- •no prior TACE for patients included for TACE;
- •no prior TARE for patients included for TARE. Prior intra-arterial treatment of the other type is allowed (prior TACE before TARE, or prior TARE before TACE). Prior non-intra-arterial treatments are allowed.
- •If TACE is proposed at the multidisciplinary tumour board (RCP):
- •Patient Child-Pugh < B8
- •Single or multiple HCC
- •Absence of lobar or truncal portal obstruction
- •Absence of bile duct dilatation
- •If treatment by TARE proposed in RCP:
- •Absence of truncal portal tumor invasion
- •Uni-lobar tumor invasion (except for centrohepatic iCCA)
- •Total bilirubin < 20 mg/l (or 35 µmol/L)
- •Patient affiliated to or benefiting from a social security scheme
- •Patient having signed an informed consent form
排除标准
- •Technical contraindication or morphological elements of predictable technical difficulty
- •Planned combined same-day therapeutic strategies at the index procedure (e.g., TACE combined with percutaneous ablation) are not allowed; sequential (non-same-day) treatments are allowed.
- •Chronic renal insufficiency (Clairance < 30 ml/min)
- •Known allergy to a contrast agent or chemotherapy agent
- •inability to participate in ambulatory care (inability to understand and follow discharge instructions, lack of reliable telephone access, absence of a responsible accompanying adult for the first night after discharge, or inability to access urgent care in a timely manner if symptoms occur)
- •Patient previously included in the study
- •Patient who, for psychological, social, family or geographical reasons, could not be regularly monitored, patient who, for psychological, social, family or geographical reasons, could not be followed regularly
- •Concomitant disease or severe uncontrolled clinical situation
- •Severe uncontrolled infection
- •Pregnant, breast-feeding or parturient woman
- •Person deprived of liberty by judicial or administrative decision
- •Person under compulsory psychiatric care
- •Person under a legal protection measure
- •Person unable to give consent
研究组 & 干预措施
Arm Ambulatory care
Experimental
Ambulatory care : Outpatient management of radiological treatment for HCC and iCCA
干预措施: Ambulatory care (Other)
Arm Conventional inpatient care
Other
Conventional inpatient care : Conventional inpatient management for radiological treatment of HCC and iCCA
干预措施: Conventional inpatient care (Other)
结局指标
主要结局
Overall patient satisfaction
时间窗: 72 hours after treatment procedure
EORTC PATSAT-C33 questionnaire. All items are scored 1 (bad) to 5 (excellent). The total score measures range in score from 0 to 100. A high score represents a high level of satisfaction with care / perceived care quality.
次要结局
- Comparing the organizations (Pain)(Day of procedure (baseline), evening after the procedure, and end of the care pathway (up to 72 hours, depending on treatment))
- Comparing the organizations (Technical succes)(Month2/Month3 visit, Month 6)
- Factors for patient satisfaction (Treatment characteristics)(Day of treatment procedure)
- Comparing the organizations (Quality of life)(At inclusion visit (pre-treatment), Day 7, Month2/Month3 visit)
- Comparing the organizations (General condition)(At inclusion visit (pre-treatment), Month2/Month3 visit)
- Comparing the organizations (Complications)(Month 6)
- Adoption (quantitative)(32 months)
- Reach (Quantitative)(One year after the end of inclusions)
- Reach (Qualitative for centers)(One year after the end of inclusions)
- Reach (Qualitative for patients)(One year after the end of inclusions)
- Comparing the organizations (Comfort and satisfaction)(72 hours after procedure)
- Factors for patient satisfaction (HADS)(Inclusion, Admission before surgery and 72 hours after procedure)
- Ambulatory pathway failure(within 72 hours post-procedure)
- Factors for patient satisfaction (Disease characteristics)(At inclusion visit (pre-treatment))
- Factors for patient satisfaction (socioeconomic)(At inclusion visit (pre-treatment))
- Factors for patient satisfaction (travel)(At inclusion visit (pre-treatment))
- Factors for patient satisfaction (comorbidities)(At inclusion visit (pre-treatment))
- Factors for patient satisfaction (ECOG)(At inclusion visit (pre-treatment))
- Factors for patient satisfaction (Quality of life)(At inclusion visit (pre-treatment), Day 7, Month 2/Month3)
- Total cost of each treatment pathway(From day of treatment to Month 2/Month 3 visit)
- Budgetary impact(5 years after study)
- Acceptability (quantitative)(At inclusion visit (pre-treatment))
- Acceptability (qualitative)(At inclusion visit (pre-treatment))
- Adoption (qualitative)(36 months)
- Relevance (reasons for refusal)(24 months)
- Relevance (patient expectations)(36 months)
- Feasibility of outpatient care(One year after the end of inclusions)
研究者
研究点 (35)
Loading locations...
相似试验
已完成
不适用
A Study Comparing Three Methods of Outpatient Follow up After Surgical Admission; Text Message, Phone Call and In-person AppointmentOutpatientsVirtual ClinicGeneral SurgeryText MessagingNCT04245020Connolly Hospital Blanchardstown208
已完成
4 期
The InsuPad in Daily Life Study - Effect of Local Heating on Postprandial Glucose Excursions Using the InsuPad DeviceType 1 Diabetes Mellitus With Diabetic NeuralgiaNCT01352767Insuline Medical Ltd.20
已完成
不适用
Outpatient Versus Inpatient Surgery for Ankle FracturesSurgical ProceduresInpatientOrthopedic ProceduresAnkle FracturesNCT05389436Christian Grundtvig Refstrup Rasmussen86
已完成
不适用
Out Patient Talc Slurry Via Indwelling Pleural Catheter for Malignant Pleural Effusion Vs Usual Inpatient ManagementPleural Effusion, MalignantNCT02517749Guy's and St Thomas' NHS Foundation Trust142
已完成
不适用
Randomised trial of outpatient versus inpatient initiation on non-invasive ventilation (NIV) in adults and children with chronic ventilatory failureRespiratoryRespiratory: Chronic ventilatory failureChronic ventilatory failureISRCTN77271265Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)24