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

NCT06715878 | Recruiting

• 1 other identifier: MIRACLE
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. The investigators want to explore this technique to robotic surgery and add suture-less technique to T1 RCC patients in randomized clinical trial.

Conditions

Kidney Neoplasms

Keywords

Microwave ablation; Nephronsparing surgery; Zero ischemia; suture less

Outcome Measures

Primary Outcomes (2)

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

  12 months minus baseline

  baseline and 12 months

• The changes of estimated GFR (eGFR)

  12 months minus baseline

  baseline and 12 months

Secondary Outcomes (9)

• estimated blood loss

  during surgery

• changes in GFR of total kidneys by renal scintigraphyby

  baseline and 12 months

• surgical margin

  postoperative up to 2 weeks after surgery

• postoperative complications

  postoperative up to 30 days

• progression-free survival

  12 months

Study Arms (2)

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.

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.

Procedure: robotic-assisted laparoscopic partial nephrectomy

Interventions

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.

Zero Ischemia suture-less group

robotic-assisted laparoscopic partial nephrectomy PROCEDURE

robotic-assisted laparoscopic partial nephrectomy

robotic-assisted partial nephrectomy group

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Ethics Committee of Shanghai Renji Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jiwei Huang, PhD.

CONTACT

02168383204; huangjiwei@renji.com

Yiran Huang, MD.

CONTACT

+8613501835219; huangyrrenji@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 4, 2024
• Study Start: March 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 10, 2024

Record last verified: 2024-12

Locations

CN (1)