Resection or Ablation of Small Kidney Tumors
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: Ablation, Surgery.
- Кому может быть актуально
- Состояния в реестре: Kidney Cancer. Базовые параметры: 18 лет — 99 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
- Швеция
- 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
Resection or Ablative Treatment of Small Renal Tumors, a Multicenter Randomized Clinical Trial
Обзор
Ablative treatments are believed to have a lower rate of complications, shorter hospital stays, and fewer interventions with benign PAD compared to partial nephrectomies in small kidney cancer lesions. The purpose of the study is to compare complications, the frequency of residual tumors, impact on kidney function, differences in quality of life, and health economic factors in a randomised study. We will also compare the oncological outcomes, including survival and recurrence of kidney cancer.
Подробное описание
Kidney cancer represents approximately 2-3% of all cancer cases, with about 400,000 new cases and 175,000 deaths worldwide in 2018. In Sweden, about 1,200 new cases of kidney cancer are detected each year. The most common age for diagnosis is between 60 and 80 years, and it is more prevalent in men than in women. Many cases are incidentally discovered during imaging studies for unrelated issues. There has been an increase in incidentally detected tumors in Sweden, from 43% in 2005 to 69% in 2021. Nephron-sparing surgery, i.e., partial nephrectomy, is recommended for preserving kidney function in localized tumors.
Ablative treatments are recommended for patients with significant comorbidities, multiple tumors, a single kidney, or other situations where surgery is not considered suitable. Prior to treatment, a biopsy is usually performed to confirm the diagnosis. Studies show variations in oncological outcomes based on the subgroups of kidney cancer treated with ablative techniques. Ablative techniques seem to have a lower risk of complications compared to surgery concerning perioperative complications, bleeding, and maintaining kidney function for a longer time. However, there are no randomized controlled studies comparing ablative treatment with nephrectomy for T1a tumors in the kidney.
3\. Hypothesis
Ablative treatment of small kidney tumors may result in shorter hospital stays with fewer complications compared to surgical resection.
There is no difference in long-term oncological outcomes between the methods.
4\. Outcome Measures
The primary purpose of the study is to compare surgical complications, findings of remaining tumors after primary treatment, and the time patients are hospitalized after each procedure. Secondary outcomes include oncological outcomes in the short and long term, as well as functional factors
Вмешательства
- Процедура Ablation
Microwave ablation, Radiofrequency ablation, Cryo ablation - Процедура Surgery
Partial or total nefrectomy
Первичные конечные точки
- Number of participants with surgical complications according to Clavien-Dindo grade 2-5 [Срок оценки: First year after inclusion]
- Radiological signs of a residual tumor at the 6-month follow-up [Срок оценки: 6-month after inclusion]
- Number of postoperative hospitalization days (LOS) [Срок оценки: Sum of total after all interventions first year after the first intervention]
Вторичные конечные точки (3)
- Cancer-specific survival (CSS) [Срок оценки: 2, 5 and 10 years after inclusion]
- Overall survival (OS) [Срок оценки: 2, 5 and 10 years after inclusion]
- Change in eGFR one year after treatment [Срок оценки: One year after inclusion]
Критерии участия
Критерии включения
- Age 18 - 99 years
- Patient suitable based on clinical status for both ablative treatment and surgery
- Primary kidney tumor
- Tumor size ≤ 3 cm
- Clinical stage of the tumor T1a (no macroscopic vascular or extrarenal invasion)
- Tumor location suitable for both ablative treatment and resection
- Absence of radiological signs of metastasis
- Biopsy with malignant pathological analysis (PAD)
- ISUP grade I-III"
Критерии исключения
- Radiological signs of metastasis
- Synchronous kidney tumors
- ISUP grade IV or sarcomatoid growth in the biopsy
- Other metastasized cancer in the last 5 years
- Patient unable to make an informed decision to participate in the study
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Швеция · 1 центр
- Karolinska University Hospital — Stockholm
Идентификаторы
NCT: NCT06278506 · 4612