Suspended

Zero Ischemia Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage : Clinical Outcomes of a Randomised Controlled Trial

What is being tested

zero ischemia laparoscopic RFA assisted TE

+ ischemia

Procedure

Who is being recruted

Urogenital Diseases+16

+ Adenocarcinoma

+ Carcinoma

From 15 to 80 Years

+8 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: April 2013

See protocol details

Summary

Principal SponsorRenJi Hospital

Study ContactYiran Huang, M.D.More contacts

Last updated: August 13, 2014

Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

Warm ischemic injury is one of the most important factors affecting renal function in partial nephrectomy (PN). Zero ischemia partial nephrectomy technique using renal arterial branch microdissection could protect renal function during surgery, but it requires longer operative time and more blood loss than conventional partial nephrectomy. The technique of zero ischemia laparoscopic radio frequency ablation assisted enucleation of renal cell carcinoma appears to be an alternative that eliminates warm ischemia, preserves the maximal parenchyma and is oncologically safe. Our study was designed to evaluate this technique in comparison with the conventional laparoscopic partial nephrectomy.

NCT01838720

Principal SponsorRenJi Hospital

Study ContactYiran Huang, M.D.More contacts

Last updated: August 13, 2014

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

90 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 15 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesAdenocarcinomaCarcinomaFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesKidney NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialPathologic ProcessesPathological Conditions, Signs and SymptomsUrogenital NeoplasmsUrologic DiseasesUrologic NeoplasmsFemale Urogenital DiseasesMale Urogenital DiseasesCarcinoma, Renal CellIschemia

Criteria

3 inclusion criteria required to participate

patients agreeable to participate in this long-term follow-up study

patients with normal contralateral renal function (differential renal function of > 40% as determined by radionuclide scintigraphy)

patients with sporadic, unilateral, newly diagnosed T1a presumed renal cell carcinoma

5 exclusion criteria prevent from participating

patients not able to tolerate the laparoscopic procedure

patients with other renal diseases

patients with previous renal surgery or history of any inflammatory conditions of the operative kidney

patients with the renal tumor close to the calyces

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

RFA will be performed for 1 to 4 cycles for 4 to 12 minutes each depending on tumor size and depth. The tumor then will be laparoscopic enucleation without hilar clamping.

Group II

Active Comparator

Renal hilum will be accurately isolated and then the artery only will be clamped during surgery.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

RenJi Hospital

Shanghai, ChinaOpen RenJi Hospital in Google Maps

SuspendedOne Study Center