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Comparison Between Partial Nephrectomy and Ablation for Renal Tumor

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ClinicalTrials.gov Identifier: NCT03094949
Recruitment Status : Unknown
Verified March 2017 by Ping Liang, Chinese PLA General Hospital.
Recruitment status was:  Recruiting
First Posted : March 29, 2017
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
Ping Liang, Chinese PLA General Hospital

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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Procedure: Partial Nephrectomy Procedure: microwave ablation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between Laparoscopic Partial Nephrectomy and Ultrasound Guided Percutaneous Microwave Ablation for T1a Renal Tumor
Actual Study Start Date : July 1, 2008
Estimated Primary Completion Date : July 1, 2017
Estimated Study Completion Date : September 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer

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.




Primary Outcome Measures :
  1. overall survival [ Time Frame: 5 years ]
    using log-rank test


Secondary Outcome Measures :
  1. local tumor progress(new lesion found adjacent to ablation zone) [ Time Frame: 5 years ]
    using log-rank test

  2. rate of intrarenal metastasis(new lesion found in the treated kidney, but not adjacent to ablation zone) [ Time Frame: 5 years ]
    using log-rank test

  3. rate of extrarenal metastasis(new lesion found outside of treated kidney) [ Time Frame: 5 years ]
    using log-rank test

  4. number of patients with side-effect and major complications [ Time Frame: 1 month ]
    using chi-square test



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03094949


Contacts
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Contact: Jie Yu, Dr 8610-66939530 yu-jie301@hotmail.com

Locations
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China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Jie Yu, Doctor    8610-66939530    yu-jie301@hotmail.com   
Sponsors and Collaborators
Chinese PLA General Hospital

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Responsible Party: Ping Liang, Prof., Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT03094949     History of Changes
Other Study ID Numbers: 301jrcs
First Posted: March 29, 2017    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ping Liang, Chinese PLA General Hospital:
microwave ablation
partial nephrectomy
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases