Renal Hypothermia During Partial Nephrectomy
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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
- Capital Disctrict Health Authority
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Ontario
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Hamilton, Ontario, Canada, L8N 4A6
- St. Joseph's Healthcare
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London, Ontario, Canada, N6C 2R5
- London Health Science Centre
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Ottawa, Ontario, Canada, K1Y 4E9
- The Ottawa Hospital
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Toronto, Ontario, Canada, M5G 2N2
- University Health Network
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Quebec
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Québec, Quebec, Canada, G1R 2J7
- Centre Hospitalier Universitaire de Quebec
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Ingen inngripen: No hypothermia
After clamping of the renal vessels, no ice slush will be used.
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Eksperimentell: Hypothermia
saline ice slush around kidney for 10 minutes.
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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 navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Renal function
Tidsramme: 12 months
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Glomerular filtration rate will be measured using the plasma clearance of 99mTc-DTPA.
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12 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Difference in affected renal function
Tidsramme: 12 months
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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).
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12 months
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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Ilias Cagiannos, MD, The Ottawa Hospital, Ottawa Hospital Research Institute
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2010-767; CIHR MOP 269009
Plan for individuelle deltakerdata (IPD)
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