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Comparison Between Partial Nephrectomy and Ablation for Renal Tumor

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03094949
Enrollment
200
Registered
2017-03-29
Start date
2008-07-01
Completion date
2017-09-01
Last updated
2017-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Cell Carcinoma

Keywords

microwave ablation, partial nephrectomy

Brief 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.

Interventions

PROCEDUREPartial 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.

PROCEDUREmicrowave 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.

Sponsors

Chinese PLA General Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
overall survival5 yearsusing log-rank test

Secondary

MeasureTime frameDescription
local tumor progress(new lesion found adjacent to ablation zone)5 yearsusing log-rank test
rate of intrarenal metastasis(new lesion found in the treated kidney, but not adjacent to ablation zone)5 yearsusing log-rank test
rate of extrarenal metastasis(new lesion found outside of treated kidney)5 yearsusing log-rank test
number of patients with side-effect and major complications1 monthusing chi-square test

Countries

China

Contacts

Primary ContactJie Yu, Dr
yu-jie301@hotmail.com8610-66939530

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026