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| Name | Class |
|---|---|
| Midwest Stone Institute. | OTHER |
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The purpose of this research study is to compare the effects on kidney function after performing the removal of a kidney tumor with or without clamping the blood vessels during surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Off-clamp partial nephrectomy | Experimental | Partial nephrectomy will be performed without clamping of the renal blood vessels. |
|
| Traditional partial nephrectomy | No Intervention | Partial nephrectomy will be performed with clamping of the renal blood vessels. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Off-clamp partial nephrectomy | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in eGFR | Renal function following nephrectomy with and without clamping will be assessed using: percent change in eGFR from baseline to 3 months post nephrectomy. | baseline and 3 months post nephrectomy |
| Percent Change From Baseline in Split Renal Function | Renal function following nephrectomy with and without clamping will be assessed using: percent change in split renal function from baseline to 3 months post nephrectomy. | baseline to 3 months post nephrectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Observations With Positive Surgical Margins. | Oncologic outcomes will be assessed at the time of nephrectomy based on percent of observations with positive surgical margins. | at the time of nephrectomy |
| Estimated Blood Loss |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert S Figenshau, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Off-clamp Partial Nephrectomy | Partial nephrectomy will be performed without clamping of the renal blood vessels. Off-clamp partial nephrectomy |
| FG001 | Traditional Partial Nephrectomy | Partial nephrectomy will be performed with clamping of the renal blood vessels. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Off-clamp Partial Nephrectomy | Partial nephrectomy will be performed without clamping of the renal blood vessels. Off-clamp partial nephrectomy |
| BG001 | Traditional Partial Nephrectomy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change From Baseline in eGFR | Renal function following nephrectomy with and without clamping will be assessed using: percent change in eGFR from baseline to 3 months post nephrectomy. | Missing 3 postoperative eGFR from the Traditional Partial Nephrectomy group and 6 from the Off-Clamp Partial Nephrectomy group. | Posted | Mean | 95% Confidence Interval | percent change in eGFR | baseline and 3 months post nephrectomy |
|
Adverse event data were collected from time of study intervention to the three-month post nephrectomy visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Off-clamp Partial Nephrectomy | Partial nephrectomy will be performed without clamping of the renal blood vessels. Off-clamp partial nephrectomy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| acute pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| urinary retention | Renal and urinary disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager of Clinical Trials | Washington University School of Medicine | 3147479781 | klima@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2015 | Mar 9, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Perioperative outcomes will be assessed based on estimated blood loss at the time of nephrectomy.
| At the time of nephrectomy |
| Percent of Observations With Metastasis | Oncologic outcomes will be assessed based on percent of observations with metastasis on follow-up imaging at 3 years post nephrectomy. | 3 years |
| Operative Time Measured in Minutes. | Perioperative outcomes will be assessed based on operative time measured in minutes at the time of nephrectomy. | At the time of nephrectomy |
| Warm Ischemia Time Measured in Minutes. | Perioperative outcomes will be assessed based on warm ischemia time measured in minutes at the time of nephrectomy. | At the time of nephrectomy. |
| Percent of Observations With Intra-operative Complications. | Perioperative outcomes will be assessed based on percent of observations with intra-operative complications at the time of nephrectomy. | At the time of nephrectomy |
| Number of Hospital Days Post Nephrectomy. | Perioperative outcomes will be assessed based number of hospital days post nephrectomy. | Day of nephrectomy to day of hospital discharge. |
| Percent of Observations With Postoperative Complications. | Perioperative outcomes will be assessed based on percent of observations with postoperative complications. | Within 3 months post nephrectomy. |
Partial nephrectomy will be performed with clamping of the renal blood vessels.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Percent Change From Baseline in Split Renal Function | Renal function following nephrectomy with and without clamping will be assessed using: percent change in split renal function from baseline to 3 months post nephrectomy. | Missing 1 postoperative renal scan from the Traditional Partial Nephrectomy group and 7 from the Off-Clamp Partial Nephrectomy group. | Posted | Mean | 95% Confidence Interval | percent change in split renal function | baseline to 3 months post nephrectomy |
|
|
|
| Secondary | Percent of Observations With Positive Surgical Margins. | Oncologic outcomes will be assessed at the time of nephrectomy based on percent of observations with positive surgical margins. | Only malignant cases were included in the analysis of positive margins. | Posted | Number | 95% Confidence Interval | percent of cases with positive margins | at the time of nephrectomy |
|
|
|
| Secondary | Estimated Blood Loss | Perioperative outcomes will be assessed based on estimated blood loss at the time of nephrectomy. | Posted | Mean | Standard Deviation | Milliliters | At the time of nephrectomy |
|
|
|
| Secondary | Percent of Observations With Metastasis | Oncologic outcomes will be assessed based on percent of observations with metastasis on follow-up imaging at 3 years post nephrectomy. | Only malignant cases were included in the analysis of metastasis on follow-up imaging. | Posted | Number | 95% Confidence Interval | percent of cases with metastasis on f/u | 3 years |
|
|
|
| Secondary | Operative Time Measured in Minutes. | Perioperative outcomes will be assessed based on operative time measured in minutes at the time of nephrectomy. | Posted | Mean | Standard Deviation | Minutes | At the time of nephrectomy |
|
|
|
| Secondary | Warm Ischemia Time Measured in Minutes. | Perioperative outcomes will be assessed based on warm ischemia time measured in minutes at the time of nephrectomy. | Posted | Mean | Standard Deviation | Minutes | At the time of nephrectomy. |
|
|
|
| Secondary | Percent of Observations With Intra-operative Complications. | Perioperative outcomes will be assessed based on percent of observations with intra-operative complications at the time of nephrectomy. | Posted | Number | 95% Confidence Interval | % of cases with intraop complications | At the time of nephrectomy |
|
|
|
| Secondary | Number of Hospital Days Post Nephrectomy. | Perioperative outcomes will be assessed based number of hospital days post nephrectomy. | Posted | Mean | Standard Deviation | Days | Day of nephrectomy to day of hospital discharge. |
|
|
|
| Secondary | Percent of Observations With Postoperative Complications. | Perioperative outcomes will be assessed based on percent of observations with postoperative complications. | Posted | Number | 95% Confidence Interval | % of cases with postop complications | Within 3 months post nephrectomy. |
|
|
|
| 1 |
| 40 |
| 2 |
| 40 |
| 0 |
| 40 |
| EG001 | Traditional Partial Nephrectomy | Partial nephrectomy will be performed with clamping of the renal blood vessels. | 0 | 40 | 4 | 40 | 4 | 40 |
| postoperative bleeding | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| pseudoaneurysm | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| sepsis | Infections and infestations | Non-systematic Assessment |
|
| fever | Infections and infestations | Non-systematic Assessment |
|
| wound dehiscence | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |