Kidney NeoplasmsNCT06715878
Zero Ischemia Robot-Assisted MWA Assisted Suture-less Tumor Enucleation of RCC With T1 Stage
A study testing Zero Ischemia Robot-Assisted Laparoscopic Microwave Ablation Assisted suture-less Enucleation and robotic-assisted laparoscopic partial nephrectomy in people with Kidney Neoplasms, run by RenJi Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Kidney Neoplasms
- What is being tested?
- Zero Ischemia Robot-Assisted Laparoscopic Microwave Ablation Assisted suture-less Enucleation and robotic-assisted laparoscopic partial nephrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ethics Committee of Shanghai Renji Hospital
Shanghai
Qi Lu, +86021-68383364, rjllb3364@163.com
About this study
Official title: Zero Ischemia Robot-Assisted Microwave Ablation Assisted Suture-less Enucleation of Renal Cell Carcinoma With T1 Stage: A Randomized Clinical 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.
Read the detailed 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.
- Conditions
- Kidney Neoplasms
- Being tested
- Zero Ischemia Robot-Assisted Laparoscopic Microwave Ablation Assisted suture-less Enucleation, robotic-assisted laparoscopic partial nephrectomy
- Keywords
- Microwave ablation, Nephronsparing surgery, Zero ischemia, suture less
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zero Ischemia Robot-Assisted Laparoscopic Microwave Ablation Assisted suture-less EnucleationProcedure or 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 nephrectomyProcedure or surgery
robotic-assisted laparoscopic partial nephrectomy
| Study group | Role | What they receive |
|---|---|---|
| Zero Ischemia suture-less group | Experimental | Patients with T1 Stage renal cell carcinoma undergoing Zero Ischemia, Robot-Assisted Microwave Ablation assisted suture-less tumor Enucleation. Receives: Procedure: Zero Ischemia Robot-Assisted Laparoscopic Microwave Ablation Assisted suture-less Enucleation |
| robotic-assisted partial nephrectomy group | Active comparator | Patients with T1 stage Renal Cell Carcinoma undergoing traditional robotic-assisted partial nephrectomy. Receives: Procedure: robotic-assisted laparoscopic partial nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The absolute change in glomerular filtration rate (GFR) of the affected kidney
12 months minus baseline
Measured: baseline and 12 months
The changes of estimated GFR (eGFR)
12 months minus baseline
Measured: baseline and 12 months
Secondary outcomes (9)
estimated blood loss
Measured: during surgery
changes in GFR of total kidneys by renal scintigraphyby
Measured: baseline and 12 months
surgical margin
Measured: postoperative up to 2 weeks after surgery
postoperative complications
Measured: postoperative up to 30 days
progression-free survival
Measured: 12 months
local recurrence
Measured: 12 months
operative time
Measured: During surgery
Hospital stay time
Measured: 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
Measured: baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start1 Mar 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney NeoplasmsStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715878
- Sponsor's protocol ID
- MIRACLE
- Status last verified
- Dec 2024
- First submitted
- 29 Nov 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zero Ischemia Robot-Assisted Microwave Ablation Assisted Suture-less Enucleation of Renal Cell Carcinoma With T1 Stage: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06715878
- Acronym / sponsor ID
- MIRACLE
- Conditions
- Kidney Neoplasms
- Keywords
- Microwave ablation, Nephronsparing surgery, Zero ischemia, suture less
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zero Ischemia suture-less group | Experimental | Procedure: Zero Ischemia Robot-Assisted Laparoscopic Microwave Ablation Assisted suture-less EnucleationPatients with T1 Stage renal cell carcinoma undergoing Zero Ischemia, Robot-Assisted Microwave Ablation assisted suture-less tumor Enucleation. |
| robotic-assisted partial nephrectomy group | Active comparator | Procedure: robotic-assisted laparoscopic partial nephrectomyPatients with T1 stage Renal Cell Carcinoma undergoing traditional robotic-assisted partial nephrectomy. |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zero Ischemia Robot-Assisted Laparoscopic Microwave Ablation Assisted suture-less EnucleationUnder 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. | Procedure or surgery | Zero Ischemia suture-less group |
| robotic-assisted laparoscopic partial nephrectomyrobotic-assisted laparoscopic partial nephrectomy | Procedure or surgery | robotic-assisted partial nephrectomy group |
Primary outcome
The absolute change in glomerular filtration rate (GFR) of the affected kidney
Time frame: baseline and 12 months
12 months minus baseline
The changes of estimated GFR (eGFR)
Time frame: baseline and 12 months
12 months minus baseline
9 secondary outcomes
estimated blood loss
Time frame: during surgery
changes in GFR of total kidneys by renal scintigraphyby
Time frame: baseline and 12 months
surgical margin
Time frame: postoperative up to 2 weeks after surgery
postoperative complications
Time frame: postoperative up to 30 days
progression-free survival
Time frame: 12 months
local recurrence
Time frame: 12 months
operative time
Time frame: During surgery
Hospital stay time
Time frame: 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
Time frame: baseline and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
Related trials for Kidney Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zero Ischemia Robot-Assisted Laparoscopic Microwave Ablation Assisted suture-less Enucleation and robotic-assisted laparoscopic partial nephrectomy in people with Kidney Neoplasms, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiwei Huang, PhD. (02168383204, huangjiwei@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The absolute change in glomerular filtration rate (GFR) of the affected kidney (time frame: baseline and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.