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NCT Number: NCT06715878

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

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.

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Key information

Conditions

Kidney Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

15 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Procedure

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

robotic-assisted laparoscopic partial nephrectomy

Primary outcomes

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

    Time frame: baseline and 12 months

    12 months minus baseline

  2. The changes of estimated GFR (eGFR)

    Time frame: baseline and 12 months

    12 months minus baseline

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

  5. progression-free survival

    Time frame: 12 months

  6. local recurrence

    Time frame: 12 months

  7. operative time

    Time frame: During surgery

  8. Hospital stay time

    Time frame: The time from the surgery day to patient discharge, up to 2 weeks

  9. changes in GFR of total kidneys by renal scintigraphyby of 3 month

    Time frame: baseline and 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Jiwei Huang, PhD.

CONTACT

[email protected]

02168383204

Yiran Huang, MD.

CONTACT

[email protected]

+8613501835219

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 4, 2024
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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