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

ConditionKidney Neoplasms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-80
SponsorRenJi Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Zero Ischemia Robot-Assisted Laparoscopic Microwave Ablation Assisted suture-less Enucleation

    Procedure/Surgery

    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

    Procedure/Surgery

    robotic-assisted laparoscopic partial nephrectomy

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Zero Ischemia suture-less groupExperimental treatment 1 intervention
Group B: robotic-assisted partial nephrectomy groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The absolute change in glomerular filtration rate (GFR) of the affected kidney

12 months minus baseline

Time frame
baseline and 12 months
2

The changes of estimated GFR (eGFR)

12 months minus baseline

Time frame
baseline and 12 months

Secondary outcomes

1

estimated blood loss

Time frame
during surgery
2

changes in GFR of total kidneys by renal scintigraphyby

Time frame
baseline and 12 months
3

surgical margin

Time frame
postoperative up to 2 weeks after surgery
4

postoperative complications

Time frame
postoperative up to 30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RenJi Hospital

Lead sponsor

Source ClinicalTrials.gov
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