Идёт набор NCT06618742

Focal Cryoballoon Ablation for Malignant Dysphagia

Без фазы С лечением Dysphagia Esophageal Cancer Cryotherapy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Cryotherapy.
Кому может быть актуально: Состояния в реестре: Dysphagia, Esophageal Cancer, Cryotherapy. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Нидерланды
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Focal Cryoballoon Ablation for Dysphagia Palliation in Patients with Advanced Esophageal Cancer

Обзор

Rationale: Dysphagia is commonly encountered in patients with esophageal carcinoma who are no candidates for treatment with curative intent. It often has a considerable impact on quality of life and can cause malnourishment. Current palliative treatments mainly include esophageal stenting and radiotherapy, but these can be associated with substantial drawbacks such as a high rate of adverse events, fatigue or an untimely/ temporary symptom improvement. Recent studies showed promising results for the use of spray cryotherapy as palliation for dysphagia. Moreover, there are suggestions that cryotherapy has a positive effect on the host's anti-tumor response. However, no data exists on the feasibility, efficacy and safety for cryoballoon therapy in the esophagus. Secondly, cryo-immunologic data in patients with EC is lacking. Objective: 1. To evaluate the feasibility of cryoballoon ablation in patients with esophageal carcinoma and symptoms of dysphagia. Additionally, efficacy and safety will be assessed. 2. To evaluate the effect of cryoballoon ablation on host's anti-tumor response. Study design: Pilot study, Multi-center Prospective Uncontrolled Intervention Study Study population: Adult patients (≥18 years) with dysphagia due to incurable esophageal carcinoma Intervention (if applicable): Focal cryoballoon ablation of visible tumor during an upper endoscopy. Cryoballoon ablation will be performed for two cycles of 12 seconds. In total, patients will undergo 3 treatment sessions (range 1-3) with an interval of 1-3 weeks based onthe severity of symptoms reported by the patient. Main study parameters/endpoints: * \- Feasibility of cryoballoon ablation defined as technical success of the procedure * Safety based on incidence of procedure-related serious adverse events * Efficacy defined as success rates two weeks after the last cryoablation treatment based on patient reported symptom improvement, and objective evaluation of the esophageal lumen that is free from tumor * Host's anti-tumor response after cryoballoon ablation based on sequential esophageal tumor biopsies and peripheral blood samples

Вмешательства

Процедура Cryotherapy
Focal cryoballoon ablation, 1-3 treatments with an interval of 1-3 weeks

Первичные конечные точки

Primary outcome safety [Срок оценки: 2 weeks]
primary outcome efficacy [Срок оценки: 2 weeks]
primary outcome feasibility [Срок оценки: 1 day]

Вторичные конечные точки (6)

secondary outcome efficacy subjective [Срок оценки: 2 weeks]
secondary outcome efficacy subjective [Срок оценки: 12 weeks]
secondary outcome pain [Срок оценки: 2 weeks]
secondary outcome safety [Срок оценки: 12 weeks]
secondary outcome other palliation [Срок оценки: 12 weeks]
Secondary outcome immunology [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

Age \&gt;18 years at time of consent
Histopathologically-confirmed esophageal / gastroesophageal cancer
Patients in the palliative setting (with or without (future) systemic chemotherapy)
Dysphagia defined as a score of ≥2 (able to swallow only semi-solids)
Signed written informed consent