Comparison Between Partial Nephrectomy and Ablation for Renal Tumor

Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03094949
• Other study ID #: 301jrcs
• Status: Recruiting
• Phase: N/A
• First received: March 1, 2017
• Last updated: March 23, 2017
• Start date: July 1, 2008
• Est. completion date: September 1, 2017

Study information

• Verified date: March 2017
• Source: Chinese PLA General Hospital
• Contact: Jie Yu, Dr
• Phone: 8610-66939530
• Email: yu-jie301[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 1, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Neoplasms
• Renal Cell Carcinoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

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