ClinicalTrials.Veeva

Menu

Zero Ischemia Laparoscopic Radio Frequency/Microwave Ablation Assisted Enucleation of Renal Cell Carcinoma With T1 Stage

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Unknown

Conditions

Kidney Neoplasms

Treatments

Procedure: conventional laparoscopic partial nephrectomy
Procedure: zero ischemia laparoscopic RFA/MVA assisted tumor enucleation (TE)

Study type

Interventional

Funder types

Other

Identifiers

NCT02734329
RenJiH-2016006

Details and patient eligibility

About

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 T1 RCC patients in randomized clinical trial in multiple centers.

Enrollment

600 estimated patients

Sex

All

Ages

15 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients with sporadic, unilateral, newly diagnosed T1 presumed renal cell carcinoma
  • patients scheduled for laparoscopic nephron sparing surgery
  • patients agreeable to participate in this long-term follow-up study

Exclusion criteria

  • patients' aged >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 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

600 participants in 2 patient groups

Zero Ischemia group
Experimental group
Description:
Radiofrequency ablation(RFA) /Microwave ablation(MVA) will be performed for 1 to 4 cycles each depending on tumor size and depth. The tumor then will be laparoscopic enucleation without hilar clamping in most cases.
Treatment:
Procedure: zero ischemia laparoscopic RFA/MVA assisted tumor enucleation (TE)
Conventional group
Active Comparator group
Description:
Renal hilum will be accurately isolated and then the artery only will be clamped during surgery.
Treatment:
Procedure: conventional laparoscopic partial nephrectomy

Trial contacts and locations

1

Loading...

Central trial contact

jiwei huang, M.D.

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems