Zero Ischemia Laparoscopic Partial Nephrectomy (ZILPAREMZ)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02634385|
Recruitment Status : Withdrawn (No funding to start project.)
First Posted : December 18, 2015
Last Update Posted : July 27, 2016
|Condition or disease||Intervention/treatment||Phase|
|Small Renal Mass||Procedure: Renal Artery Embolization Procedure: Partial Nephrectomy (Surgical Resection)||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Zero Ischemia Laparoscopic Partial Nephrectomy in Combination With Superselective Renal Artery Embolization for Small Renal Masses: A Feasibility Trial|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||April 2016|
|Estimated Study Completion Date :||June 2016|
No Intervention: Small Renal Mass
Patient's with a small renal mass will be undergoing embolization prior to laparoscopic partial nephrectomy.
Procedure: Renal Artery Embolization
Patients will be receiving embolization prior to planned partial nephrectomy.
Procedure: Partial Nephrectomy (Surgical Resection)
Patients will be undergoing planned partial nephrectomy post embolization.
- Extirpative time [ Time Frame: Duration of Surgical Procedure ]From initial renal tissue breach until completion of bolster placement. Calculated in minutes.
- Warm ischemia time [ Time Frame: Duration of Surgical Procedure ]From renal vessel clamping to unclamping during nephrectomy (only if clamping has occurred). Calculated in minutes.
- Mean estimated blood loss (measured in ml) [ Time Frame: Duration of Surgical Procedure ]From the start of procedure (Nephrectomy), until the end of the procedure.
- Mean hospital stay [ Time Frame: 2-10 Days ]Date admitted for procedure until date of discharge. Measure in calendar days.
- Blood transfusions [ Time Frame: From date of pre-op up to 6 months post-op ]Prior to Embolization procedure and pre and post-nephrectomy.
- Conversion to other type of surgery (i.e. Radical Nephrectomy) [ Time Frame: Duration of Surgical Procedure ]Minutes from the start of procedure (Nephrectomy).
- Identification of other complications (i.e. readmission, arteriovenous malformations) [ Time Frame: Up to 24 months post-operatively. ]Complications will be monitored after patient is discharged up until two years post-operatively.
- Overall survival rates [ Time Frame: Up to 24 months post-operatively. ]Follow-up will be monitored.
- Pathological Results (% of negative margins and benign versus malignant tumours). [ Time Frame: 7 to 14 days post nephrectomy. ]Pathology results are usually not released until 7-14 days post nephrectomy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02634385
|St. Joseph's Healthcare Hamilton - McMaster Institute of Urology|
|Hamilton, Ontario, Canada, L8N4A6|