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

Kidney Neoplasms Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02734329
• Other study ID #: RenJiH-2016006
• Status: Recruiting
• Phase: N/A
• First received: February 29, 2016
• Last updated: May 1, 2016
• Start date: April 2016

Study information

• Verified date: May 2016
• Source: RenJi Hospital
• Contact: jiwei huang, M.D.
• Phone: 862168383776
• Email: jiweihuang[@]outlook.com
• Is FDA regulated: No
• Health authority: China: School of Medicine, Shanghai Jiao Tong University
• Study type: Interventional

Clinical 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. The investigators want to explore this technique to T1 RCC patients in randomized clinical trial in multiple centers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 80 Years

Eligibility

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 in?ammatory conditions of the operative kidney

• patients with the renal tumor involving urinary collecting system

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Neoplasms

Intervention

Procedure:
• conventional laparoscopic partial nephrectomy
renal artery will be clamped during surgery.
• zero ischemia laparoscopic RFA/MVA assisted tumor enucleation (TE)

Locations

Country	Name	City	State
China	Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai

Sponsors (6)

Lead Sponsor	Collaborator
RenJi Hospital	Changhai Hospital, Fudan University, Shanghai Changzheng Hospital, Shanghai Sixth People's Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change in glomerular ?ltration rate (GFR) of the affected kidney		Baseline and 30 months	No
Primary	changes of estimated GFR (eGFR)		Baseline and 30 months	No
Secondary	estimated blood loss		during surgery	Yes
Secondary	rates of positive surgical margin		postoperative,up to 2 weeks after surgery	Yes
Secondary	postoperative complications		postoperative,up to 30 days	Yes
Secondary	the rate of local recurrence		through study completion, an average of 3 years	Yes
Secondary	operative time		During surgery	No
Secondary	Hospital stay time		The time from the surgery day to patient discharge, up to 2 weeks	No
Secondary	progression-free survival rate		through study completion, an average of 3 years	No