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NCT Number: NCT02326558

Comparison of Microwave Ablation-Assisted Enucleation and Conventional Laparoscopic Partial Nephrectomy in the Treatment of T1a Renal Cell Carcinoma

The purpose of this study is to evaluate the feasibility, safety and efficiency of zero ischemia laparoscopic microwave ablation-assisted enucleation in comparison with conventional laparoscopic partial nephrectomy in the treatment of T1a renal cell carcinoma.

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Key information

Conditions

Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

15 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

About this study

Microwave ablation has been widely used in the minimally-invasive treatment of renal tumors. Recently, a technique of laparoscopic microwave ablation-assisted renal tumor enucleation was developed, but the experience was preliminary. This study aims to evaluate the feasibility, safety and efficiency of this technique, particularly its role in the preservation of renal function, in comparison with conventional laparoscopic partial nephrectomy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with sporadic, unilateral, newly diagnosed T1a presumed renal cell carcinoma
  • exophytic cancer
  • distance from the hilar renal vessels and urinary collecting system >= 1cm
  • patients with normal contralateral renal function (differential renal function of >40% as determined by renal scintigraphy)
  • patients giving consent to the participation in the current clinical trial

Exclusion criteria

  • patients with a history of other renal diseases, such as urinary lithiasis
  • patients with a history of renal surgery

Treatment and study plan

laparoscopic microwave ablation-assisted enucleation

Procedure

conventional laparoscopic partial nephrectomy

Procedure

Primary outcomes

  1. absolute change in glomerular filtration rate (GFR) of the affected kidney

    Time frame: baseline, 3 months and 12 months

    measured by renal scintigraphy

Secondary outcomes

  1. absolute change in eGFR of the affected kidney

    Time frame: baseline, 3 months, 6 months and 12 months

  2. absolute change in total GFR

    Time frame: baseline and 6 months

    measured by renal scintigraphy

  3. blood loss

    Time frame: during surgery

  4. operation time

    Time frame: during surgery

  5. surgical margin

    Time frame: 1 month

    assessed according to the pathology report of the operation specimen

  6. postoperative complications

    Time frame: up to 6 months

    number of participants with postoperative complications graded by Clavien- Dindo system

  7. progression-free survival

    Time frame: 12 months

  8. local recurrence

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Collaborators

  • National Natural Science Foundation of China

Registry information

Official study title

Comparison of Zero Ischemia Laparoscopic Microwave Ablation-Assisted Enucleation and Conventional Laparoscopic Partial Nephrectomy in the Treatment of T1a Renal Cell Carcinoma

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Dec 29, 2014
Registry last updated
Apr 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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