NCT03094949

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
8.7 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2017

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 29, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2017

Enrollment Period

9 years

First QC Date

March 1, 2017

Last Update Submit

March 23, 2017

Conditions

Renal Cell Carcinoma

Keywords

microwave ablationpartial nephrectomy

Outcome Measures

Primary Outcomes (1)

  • overall survival

    using log-rank test

    5 years

Secondary Outcomes (4)

  • local tumor progress(new lesion found adjacent to ablation zone)

    5 years

  • rate of intrarenal metastasis(new lesion found in the treated kidney, but not adjacent to ablation zone)

    5 years

  • rate of extrarenal metastasis(new lesion found outside of treated kidney)

    5 years

  • number of patients with side-effect and major complications

    1 month

Study Arms (2)

Partial Nephrectomy

ACTIVE COMPARATOR

a kind of operation for renal tumor

Procedure: Partial Nephrectomy

microwave ablation

EXPERIMENTAL

a kind of minimally invasive therapy by using microwave device for renal tumors

Procedure: microwave ablation

Interventions

Partial NephrectomyPROCEDURE

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.

Partial Nephrectomy
microwave ablationPROCEDURE

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.

microwave ablation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Central Study Contacts

Jie Yu, Dr

CONTACT

8610-66939530yu-jie301@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

March 1, 2017

First Posted

March 29, 2017

Study Start

July 1, 2008

Primary Completion

July 1, 2017

Study Completion

September 1, 2017

Last Updated

March 29, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share

Locations

CN(1)