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Renal Hypothermia During Partial Nephrectomy

25. oktober 2016 opdateret af: Ottawa Hospital Research Institute

A Randomized Controlled Trial of Renal Hypothermia During Partial Nephrectomy

The Objective is to determine if renal hypothermia during open partial nephrectomy results in improved post-operative renal function compared to warm ischemia.

Primary Aim is to determine the effect of hypothermia on preservation of overall renal function compared to no hypothermia in patients who require hilar vessel clamping during open partial nephrectomy for a renal tumor.

Hypothesis: Hypothermia will result in improved post-operative preservation of overall renal function.

Secondary Aim is to determine the effect of hypothermia on preservation of affected renal function (kidney with the tumor) compared to no hypothermia in patients who require hilar vessel clamping during open partial nephrectomy for a renal tumor.

Hypothesis: Hypothermia will result in improved post-operative preservation of affected renal function.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The incidence of renal cell carcinoma is increasing and in 2008 it is estimated that over 51,000 new renal cancers will be diagnosed in the United States. To preserve renal function, urologists commonly remove the diseased segment of the kidney (partial nephrectomy) instead of removing the entire kidney (radical nephrectomy). While the benefit of preserving function in patients with renal cell carcinoma has become clear, optimal preservation techniques are yet to be determined. Specifically, the role of hypothermia during partial nephrectomy has been inadequately studied despite theoretical benefit. The investigators objective is to assess the effectiveness of renal hypothermia during partial nephrectomy. The investigators hypothesis is that renal hypothermia during partial nephrectomy results in improved post-operative renal function compared to warm ischemia.

Methods: To test the investigators hypothesis, 180 partial nephrectomy patients will be randomized to cold or warm ischemia. Global and side-specific renal function will be assessed pre-operatively and 12 months post-operatively using radionucleotide clearance and renal scintigraphy.

Significance: To the investigators knowledge, this study will be the first prospective trial to evaluate the clinical impact of renal hypothermia during partial nephrectomy. Since renal function preservation is the primary purpose of partial nephrectomy, these findings will have an important impact on surgical technique and patient outcome.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

184

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Capital Disctrict Health Authority
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Healthcare
      • London, Ontario, Canada, N6C 2R5
        • London Health Science Centre
      • Ottawa, Ontario, Canada, K1Y 4E9
        • The Ottawa Hospital
      • Toronto, Ontario, Canada, M5G 2N2
        • University Health Network
    • Quebec
      • Québec, Quebec, Canada, G1R 2J7
        • Centre Hospitalier Universitaire de Quebec

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patients presenting with a renal mass deemed amenable to an open partial nephrectomy regardless of stage, histology, presence of solitary kidney, multiple tumors or renal function. Participating surgeons will identify patients they consider to be appropriate candidates for partial nephrectomy with or without renal hypothermia.
  • Willing to consent to randomization
  • Willing to comply with study protocol

Exclusion Criteria:

  • Bilateral renal tumours with planned surgery either partial or radical nephrectomy on the contralateral kidney within the 12 months of the study.
  • Life expectancy < 3 months as deemed by treating physician
  • Age less than 18 years old
  • Pregnancy

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: No hypothermia
After clamping of the renal vessels, no ice slush will be used.
Eksperimentel: Hypothermia
saline ice slush around kidney for 10 minutes.
Procedure: Renal hypothermia

Within 10 seconds of clamping the renal vessels, the kidney will be encased with saline ice slush for a period of 10 minutes. The slush will be created from sterile saline using an operating room slush machine. The slush is applied by the surgeon and lightly packed around the kidney to ensure complete coverage with at least a 2 cm layer. Slush removal is performed by the surgeon beginning at the 10 minute mark. Enough slush is removed to uncover the tumour area. Surgical incision of the kidney begins as soon as the tumour area is uncovered.

When reconstruction of the kidney is complete, the slush is completely removed from the surgical field and the clamps are removed from the renal vein and artery.

Andre navne:
  • Is

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Renal function
Tidsramme: 12 months
Glomerular filtration rate will be measured using the plasma clearance of 99mTc-DTPA.
12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Difference in affected renal function
Tidsramme: 12 months
Side-specific renal function will be calculated by the product of overall glomerular filtration (determined from 99mTc-DTPA plasma clearance) and relative renal contribution (determined from 99mTc-DTPA renal scintigraphy).
12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ottawa Hospital Research Institute

Samarbejdspartnere

Canadian Institutes of Health Research (CIHR)

Efterforskere

  • Ledende efterforsker: Ilias Cagiannos, MD, The Ottawa Hospital, Ottawa Hospital Research Institute

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2012

Primær færdiggørelse (Forventet)

1. september 2017

Studieafslutning (Forventet)

1. september 2017

Datoer for studieregistrering

Først indsendt

6. februar 2012

Først indsendt, der opfyldte QC-kriterier

8. februar 2012

Først opslået (Skøn)

9. februar 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

27. oktober 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. oktober 2016

Sidst verificeret

1. oktober 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2010-767; CIHR MOP 269009

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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