Comparison Between Partial Nephrectomy and Ablation for Renal Tumor

Comparison Between Laparoscopic Partial Nephrectomy and Ultrasound Guided Percutaneous Microwave Ablation for T1a Renal Tumor

The therapeutic effectiveness of ultrasound guided cooled-probe microwave ablation and laparoscopic partial nephrectomy on T1a renal cell carcinoma is compared to find a better approach for renal tumor.

Study Overview

• Status: Unknown
• Conditions: Renal Cell Carcinoma
• Intervention / Treatment: Procedure: Partial Nephrectomy; Procedure: microwave ablation

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Recruiting
      • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with the RCC of ≤4 cm maximum diameter were included in the study.

Exclusion Criteria:

• Patients having RCCs with vascular invasion, extrarenal spread or with benign renal tumors were excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Partial Nephrectomy; a kind of operation for renal tumor	Procedure: Partial Nephrectomy; The renal capsule is cut in a monopolar fashion around the tumor. After the renal artery is clamped with a bulldog clamp, cold cutting by scissors into the renal parenchymal boundary of the tumor is performed with an optimal surgical margin (a few millimeters). After retrograde injection of diluted indigo carmine, continuous suturing of the opened collecting system and transection of the major vessels is performed with intracorporeal knot-tying. Parenchymal suturing is performed in a continuous fashion. The 20-30 cm length of thread is used, and a knot is made at the end of the thread. A large Hem-o-lok polymer clip (Weck Closure System, Research Triangle Park, NC) is attached on the proximal side of the knot. Before the thread is tightened or cinched, the parenchyma is sutured in a running fashion with three or four stitches without any bolster so that the renal bed is kept in its natural position during the suturing.
Experimental: microwave ablation; a kind of minimally invasive therapy by using microwave device for renal tumors	Procedure: microwave ablation; Microwave ablation is a technique that uses thermal therapy to induce complete necrosis of tumor in situ by using microwave ablation device.Antenna in the microwave ablation device was percutaneously inserted into the tumor and placed at designated place under US guidance. For tumors less than 1.5 cm, one antenna was inserted and for tumors measuring 1.5 cm or greater, two antennae were inserted in parallel with an inter-antenna distance of 1.0-2.5 cm, which were used simultaneously during MWA to obtain larger ablation zone. A 20G thermocouple was inserted about 0.5-1 cm away from the tumor for real-time temperature monitoring during MWA. MW emission didn't stop until the heat-generated hyperechoic water vapor completely encompassed the entire tumor and the measured temperature reached 60°C or remained above 54°C for at least three minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	using log-rank test	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
local tumor progress(new lesion found adjacent to ablation zone)	using log-rank test	5 years
rate of intrarenal metastasis(new lesion found in the treated kidney, but not adjacent to ablation zone)	using log-rank test	5 years
rate of extrarenal metastasis(new lesion found outside of treated kidney)	using log-rank test	5 years
number of patients with side-effect and major complications	using chi-square test	1 month

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2008
• Primary Completion (Anticipated): July 1, 2017
• Study Completion (Anticipated): September 1, 2017

Study Registration Dates

• First Submitted: March 1, 2017
• First Submitted That Met QC Criteria: March 23, 2017
• First Posted (Actual): March 29, 2017

Study Record Updates

• Last Update Posted (Actual): March 29, 2017
• Last Update Submitted That Met QC Criteria: March 23, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: microwave ablation; partial nephrectomy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell
• Other Study ID Numbers: 301jrcs

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No