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

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

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.

Study Overview

• Status: Completed
• Conditions: Renal Cell Carcinoma
• Intervention / Treatment: Procedure: laparoscopic microwave ablation-assisted enucleation; Procedure: conventional laparoscopic partial nephrectomy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 183
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Renji hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: microwave enucleation; zero ischemia laparoscopic microwave ablation-assisted enucleation of the tumor	Procedure: laparoscopic microwave ablation-assisted enucleation
Active Comparator: laparoscopic partial nephrectomy; conventional laparoscopic partial nephrectomy with clamping of the renal artery	Procedure: conventional laparoscopic partial nephrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
absolute change in glomerular filtration rate (GFR) of the affected kidney	measured by renal scintigraphy	baseline, 3 months and 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Collaborators: National Natural Science Foundation of China
• Investigators: Study Chair: Yi-Ran Huang, M.D., Renji hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: December 17, 2014
• First Submitted That Met QC Criteria: December 22, 2014
• First Posted (Estimate): December 29, 2014

Study Record Updates

• Last Update Posted (Actual): April 5, 2017
• Last Update Submitted That Met QC Criteria: April 3, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: renal cell carcinoma; ablation; enucleation; microwave; zero ischemia
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Carcinoma
• Other Study ID Numbers: RenJiH-URO-001