Zero Ischemia Robot-Assisted MWA Assisted Suture-less Tumor Enucleation of RCC With T1 Stage

Официальное название

Zero Ischemia Robot-Assisted Microwave Ablation Assisted Suture-less Enucleation of Renal Cell Carcinoma With T1 Stage: A Randomized Clinical Trial

Обзор

Zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation has been proved to enable tumor excision with relatively better renal function preservation comparing with conventional laparoscopic partial nephrectomy for T1a renal cell carcinoma (RCC) in a randomized clinical trial in single center. The investigators want to explore this technique to robotic surgery and add suture-less technique to T1 RCC patients in randomized clinical trial.

Подробное описание

Zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation has been proved to enable tumor excision with relatively better renal function preservation comparing with conventional laparoscopic partial nephrectomy for T1a renal cell carcinoma (RCC) in a randomized clinical trial in single center. The investigators want to explore this technique to robotic surgery and add suture-less technique to T1 RCC patients in randomized clinical trial. This project is based on the previous research and aims to develop an approach of the combination of intraoperative real time contrast-enhanced ultrasonography technology, sutureless technology and the zero ischemia robot-Assisted tumor enucleation of the kidney. By using the real time contrast-enhanced ultrasonography technology, the current shortcomings of the zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation were overcome. The degree of elimination was monitored during surgery to avoid excessive bleeding caused by insufficient ablation during the surgery. Beside, the difficulty of zero ischemia laparoscopic radio frequency ablation is reduced, and doctors can quickly grasp the learning curve of this technology.

Вмешательства

• Процедура Zero Ischemia Robot-Assisted Laparoscopic Microwave Ablation Assisted suture-less Enucleation
  Under the visualization of ultrasound contrast imaging through the operative channel, a microwave ablation probe was inserted into the tumor (at the interface between the tumor and kidney, close to the tumor base). The microwave ablation device was used, with a power setting of 70 W for initiating microwave ablation. Depending on the tumor volume and depth, 1-3 ablation cycles were performed, with each cycle lasting 1-3 minutes. After reaching the pseudocapsule of the tumor, a combination of blu
• Процедура robotic-assisted laparoscopic partial nephrectomy
  robotic-assisted laparoscopic partial nephrectomy

Первичные конечные точки

• The absolute change in glomerular filtration rate (GFR) of the affected kidney [Срок оценки: baseline and 12 months]
• The changes of estimated GFR (eGFR) [Срок оценки: baseline and 12 months]

Вторичные конечные точки (9)

• estimated blood loss [Срок оценки: during surgery]
• changes in GFR of total kidneys by renal scintigraphyby [Срок оценки: baseline and 12 months]
• surgical margin [Срок оценки: postoperative up to 2 weeks after surgery]
• postoperative complications [Срок оценки: postoperative up to 30 days]
• progression-free survival [Срок оценки: 12 months]
• local recurrence [Срок оценки: 12 months]
• operative time [Срок оценки: During surgery]
• Hospital stay time [Срок оценки: The time from the surgery day to patient discharge, up to 2 weeks]
• changes in GFR of total kidneys by renal scintigraphyby of 3 month [Срок оценки: baseline and 3 months]

Критерии участия

Критерии включения

• patients with sporadic, unilateral, newly diagnosed T1 presumed renal cell carcinoma
• patients scheduled for robot-assisted laparoscopic nephron sparing surgery
• patients with normal contralateral renal function (differential renal function of >40% as determined by radionuclide scintigraphy)
• patients agreeable to participate in this long-term follow-up study

Критерии исключения

• patients' age >80 years
• patients with other renal diseases (including kidney stone, glomerular nephritis, etc.)which might affect the renal function of the operative kidney
• patients not able to tolerate the robot-assisted laparoscopic procedure
• patients with previous renal surgery or history of any inflammatory conditions of the operative kidney
• patients with the renal tumor involving urinary collecting system or distance from the tumor edge to the collecting system ≤ 4 mm

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

Китай · 1 центр

• Ethics Committee of Shanghai Renji Hospital — Шанхай

Идентификаторы

NCT: NCT06715878 · MIRACLE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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