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

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Kidney Neoplasms

Treatments: Procedure: robotic-assisted laparoscopic partial nephrectomy; Procedure: Zero Ischemia Robot-Assisted Laparoscopic Microwave Ablation Assisted suture-less Enucleation

Study type: Interventional

Funder types: Other

Identifiers

NCT06715878

MIRACLE

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 15 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

80 participants in 2 patient groups

Zero Ischemia suture-less group

Experimental group

Description:

Patients with T1 Stage renal cell carcinoma undergoing Zero Ischemia, Robot-Assisted Microwave Ablation assisted suture-less tumor Enucleation.

Treatment:

Procedure: Zero Ischemia Robot-Assisted Laparoscopic Microwave Ablation Assisted suture-less Enucleation

robotic-assisted partial nephrectomy group

Active Comparator group

Description:

Patients with T1 stage Renal Cell Carcinoma undergoing traditional robotic-assisted partial nephrectomy.

Treatment:

Procedure: robotic-assisted laparoscopic partial nephrectomy