NCT01809119

Brief Summary

Partial nephrectomy is considered the standard treatment for renal tumors smaller than 7 cm. With the evolution of image diagnostic tools and dissemination of its use, smaller tumors are being commonly diagnosed and treated. The partial open nephrectomy is still considered the gold standard technique for nephron sparing surgery, especially when the surgeon is not experienced with the minimally invasive surgery. In the last 15 years, uncountable minimally invasive techniques were developed, including the laparoscopic partial nephrectomy. The objective of this study is compare the partial laparoscopic nephrectomy to open partial nephrectomy in terms of perioperative, oncologic and functional outcomes. A balanced randomized prospective trial will be conducted. One group of patients will be submitted to to open partial nephrectomy while the other group of patients will be submitted to laparoscopic partial nephrectomy. A randomized prospective trial comparing the two techniques is necessary to determine the differences in outcomes between them and if the laparoscopic partial nephrectomy can be performed without harms to the patients.

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
242

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2012

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 12, 2013

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

May 14, 2018

Status Verified

May 1, 2018

Enrollment Period

7 years

First QC Date

March 8, 2013

Last Update Submit

May 8, 2018

Conditions

Kidney Neoplasms

Keywords

Kidney Neoplasms, Minimally invasive surgery, Renal cell carcinoma

Outcome Measures

Primary Outcomes (1)

  • Surgical Complications

    6 months

Secondary Outcomes (2)

  • Renal Function

    2 years

  • Oncological outcomes

    5 years

Study Arms (2)

Laparoscopic Partial Nephrectomy

EXPERIMENTAL

Patients with kidney neoplasms submitted to laparoscopic partial nephrectomy

Procedure: Partial nephrectomy

Open Partial Nephrectomy

ACTIVE COMPARATOR

Patients with kidney neoplasms submitted to open partial nephrectomy

Procedure: Partial nephrectomy

Interventions

Partial nephrectomyPROCEDURE
Laparoscopic Partial NephrectomyOpen Partial Nephrectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with renal tumor cT1N0M0; (\<7 cm)
  • Normal renal function (serum creatinine \<1.2 and glomerular filtration rate\> 60mL/min/1.73m2)
  • Tumor only

You may not qualify if:

  • Functional or anatomical solitary kidney
  • Horseshoe kidney, ectopic or malformed
  • Clinical contraindication to surgery
  • Contraindication to laparoscopic surgery
  • Association with other renal pathologies
  • Evidence of lymph node or systemic disease in preoperative staging

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Institute of the State of São Paulo

São Paulo, 01246-000, Brazil

RECRUITING

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Marcos F Dall'Oglio, M.D., Associate Professor

    Cancer Institute of the State of São Paulo - University of Sao Paulo

    STUDY DIRECTOR

  • Giuliano B Guglielmetti, Doctor

    Cancer Institute of the State of São Paulo - University of Sao Paulo

    PRINCIPAL INVESTIGATOR

  • Alexandre C Sant'Anna, Doctor

    Cancer Institute of the State of São Paulo - University of Sao Paulo

    STUDY CHAIR

Central Study Contacts

Sanarelly P Adonias, Study Coordinator

CONTACT

+ 55 11 3893-2528enfpesq2.urousp@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. Associate Professor

Study Record Dates

First Submitted

March 8, 2013

First Posted

March 12, 2013

Study Start

December 1, 2012

Primary Completion

December 1, 2019

Study Completion

January 1, 2020

Last Updated

May 14, 2018

Record last verified: 2018-05

Locations

BR(1)