Zero Ischemia Robot-Assisted MWA Assisted Suture-less Tumor Enucleation of RCC With T1 Stage
NCT ID: NCT06715878
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2024-03-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Zero Ischemia suture-less group
Patients with T1 Stage renal cell carcinoma undergoing Zero Ischemia, Robot-Assisted Microwave Ablation assisted suture-less tumor Enucleation.
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 blunt dissection, sharp cutting, and blunt dissection was employed to separate the tumor from the renal parenchyma . The renal artery was not occluded during the procedure.If intraoperative injury to the collecting system is suspected, the collecting system should be sutured normally, while simultaneously suturing the outer layer of renal parenchyma to prevent urine leakage.
robotic-assisted partial nephrectomy group
Patients with T1 stage Renal Cell Carcinoma undergoing traditional robotic-assisted partial nephrectomy.
robotic-assisted laparoscopic partial nephrectomy
robotic-assisted laparoscopic partial nephrectomy
Interventions
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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 blunt dissection, sharp cutting, and blunt dissection was employed to separate the tumor from the renal parenchyma . The renal artery was not occluded during the procedure.If intraoperative injury to the collecting system is suspected, the collecting system should be sutured normally, while simultaneously suturing the outer layer of renal parenchyma to prevent urine leakage.
robotic-assisted laparoscopic partial nephrectomy
robotic-assisted laparoscopic partial nephrectomy
Eligibility Criteria
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Inclusion Criteria
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
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
15 Years
80 Years
ALL
No
Sponsors
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RenJi Hospital
OTHER
Responsible Party
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Locations
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Ethics Committee of Shanghai Renji Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Qi Lu
Role: primary
Other Identifiers
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MIRACLE
Identifier Type: -
Identifier Source: org_study_id