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Идёт набор NCT07272187

Endoscopic Ultrasound-guided Radiofrequency Ablation for Upper Gastrointestinal Tract Lesions

— Наблюдательное Insulinoma; Pancreas MEN1 NETs Radiofrequency Ablation

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: observational study.
Кому может быть актуально
Состояния в реестре: Insulinoma; Pancreas, MEN1, NETs, Radiofrequency Ablation. 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
Дания
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

Endoscopic Ultrasound-guided Radiofrequency Ablation for Upper Gastrointestinal Tract Lesions - a Prospective Study

Обзор

The goal of this observational study is to evaluate the long-term clinical effectiveness of EUS-RFA and quality of life in patients with pancreatic or adrenal tumors recieving EUS-RFA. Primary Objectives: * Clinical effectiveness: To evaluate the proportion of included patients who show doc-umented improvement in their clinical symptoms and biochemical parameters (blood test results) over time. * Patient satisfaction: To assess patient satisfaction with the procedure and subsequent disease-related quality of life, measured using validated questionnaires. Secondary Objectives: * Safety: To determine the proportion of treated patients who experience complications, as defined by the AGREE classification, within 30 days after the procedure. * Technical success: To assess the proportion of included patients in whom the EUS-RFA procedure can be successfully completed. Exploratory Objectives: • To identify factors associated with adverse events and factors related to clinical success or lack there of. The study is observational. All participant will receive EUS-RFA as part of their standard clinical care. Participants will: * Undergo EUS-RFA, in which a fine needle is guided into the tumor using an endo-scope and ultrasound imaging. Radiofrequency energy is applied through the needle to heat and destroy tumor cells while protecting the surrounding tissue. * Have follow-up visits including blood tests, imaging scans, and clinical evaluations at regular intervals for up to 5 years after treatment. * Complete validated questionnaires about satisfaction and quality of life. The study will include approximately 138 patients recruited between 2025 and 2035 from two Danish hospital departments (Herlev and Gentofte Hospital and Rigshospitalet). Data collection will continue until 2040 to assess long-term outcomes. This study may help determine whether EUS-RFA can serve as a safe and effective alternative to traditional surgery for selected patients with small hormone-producing or benign tumors in the pancreas or adrenal glands, potentially reducing surgical risks and improving recovery and quality of life.

Вмешательства

  • Другое observational study
    Observational study. Patients recieve standard clinical care with routine follow up

Первичные конечные точки

  • Patient satisfaction [Срок оценки: From enrollment and 5 years forward]
  • Clinical efficacy [Срок оценки: From enrollment and 5 years forward]
Вторичные конечные точки (2)
  • Adverse events [Срок оценки: From enrollment and 5 years forward]
  • Technical success [Срок оценки: From enrollment and 5 years forward]

Критерии участия

Критерии включения

  • Patients with one or more lesions amendable to undergo EUS-RFA
  • Insulinomas ≤ 25 mm confirmed by a 72-h fasting test, cross-sectional scanning, and a biopsy with low Ki67 index (<10%)
  • Non-functional pNEN lesions between 10-20 mm and growing, confirmed by a biopsy with low Ki67 index (<10%), or larger pNEN lesions in patients who are not candidates for surgical treatment
  • Unilateral APA with benign characteristics on non-contrast enhanced CT located in the left adrenal and confirmed lateralization on AVS
  • Adult habile patients
  • Signed informed consent

Критерии исключения

  • Severe multimorbidity (ASA score ≥ IV or ECOG performance score ≥ 4)
  • Uncorrected coagulopathy (INR >1.8 or thrombocyte count < 50 mia/L)
  • Pregnancy
  • Metastatic malignancy with expected remaining life expectancy < 3 years
  • Stenosis in upper GI tract or altered anatomy (e.g. previous gastrectomy) preventing the passage of an echoendoscope

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Дания · 1 центр
  • Herlev og Gentofte Hospital — Herlev

Идентификаторы

NCT: NCT07272187 · p-2025-19131

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗