Comparison of Microwave Ablation-Assisted Enucleation and Conventional Laparoscopic Partial Nephrectomy in the Treatment of T1a Renal Cell Carcinoma

Renal Cell Carcinoma Clinical Trial

Official title:

Comparison of Zero Ischemia Laparoscopic Microwave Ablation-Assisted Enucleation and Conventional Laparoscopic Partial Nephrectomy in the Treatment of T1a Renal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02326558
• Other study ID #: RenJiH-URO-001
• Status: Completed
• Phase: N/A
• First received: December 17, 2014
• Last updated: April 3, 2017
• Start date: October 2014
• Est. completion date: September 2016

Study information

• Verified date: April 2017
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the feasibility, safety and efficiency of zero ischemia laparoscopic microwave ablation-assisted enucleation in comparison with conventional laparoscopic partial nephrectomy in the treatment of T1a renal cell carcinoma.

Description:

Microwave ablation has been widely used in the minimally-invasive treatment of renal tumors. Recently, a technique of laparoscopic microwave ablation-assisted renal tumor enucleation was developed, but the experience was preliminary. This study aims to evaluate the feasibility, safety and efficiency of this technique, particularly its role in the preservation of renal function, in comparison with conventional laparoscopic partial nephrectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: September 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients with sporadic, unilateral, newly diagnosed T1a presumed renal cell carcinoma

• exophytic cancer

• distance from the hilar renal vessels and urinary collecting system >= 1cm

• patients with normal contralateral renal function (differential renal function of >40% as determined by renal scintigraphy)

• patients giving consent to the participation in the current clinical trial

Exclusion Criteria:

• patients with a history of other renal diseases, such as urinary lithiasis

• patients with a history of renal surgery

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Procedure:
• laparoscopic microwave ablation-assisted enucleation

• conventional laparoscopic partial nephrectomy

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
RenJi Hospital	National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	absolute change in glomerular filtration rate (GFR) of the affected kidney	measured by renal scintigraphy	baseline, 3 months and 12 months
Secondary	absolute change in eGFR of the affected kidney		baseline, 3 months, 6 months and 12 months
Secondary	absolute change in total GFR	measured by renal scintigraphy	baseline and 6 months
Secondary	blood loss		during surgery
Secondary	operation time		during surgery
Secondary	surgical margin	assessed according to the pathology report of the operation specimen	1 month
Secondary	postoperative complications	number of participants with postoperative complications graded by Clavien- Dindo system	up to 6 months
Secondary	progression-free survival		12 months
Secondary	local recurrence		12 months