Trial Outcomes & Findings for Off Clamp Randomization (NCT NCT01732120)

NCT ID: NCT01732120

Last Updated: 2023-05-19

Results Overview

Renal function following nephrectomy with and without clamping will be assessed using: percent change in eGFR from baseline to 3 months post nephrectomy.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 80 participants
• Primary outcome timeframe: baseline and 3 months post nephrectomy
• Results posted on: 2023-05-19

Participant Flow

Participant milestones

Measure	Off-clamp Partial Nephrectomy Partial nephrectomy will be performed without clamping of the renal blood vessels. Off-clamp partial nephrectomy	Traditional Partial Nephrectomy Partial nephrectomy will be performed with clamping of the renal blood vessels.
Overall Study STARTED	40	40
Overall Study COMPLETED	40	40
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Off Clamp Randomization

Baseline characteristics by cohort

Measure	Off-clamp Partial Nephrectomy n=40 Participants Partial nephrectomy will be performed without clamping of the renal blood vessels. Off-clamp partial nephrectomy	Traditional Partial Nephrectomy n=40 Participants Partial nephrectomy will be performed with clamping of the renal blood vessels.	Total n=80 Participants Total of all reporting groups
Age, Continuous	56.6 years STANDARD_DEVIATION 9.8 • n=5 Participants	59.4 years STANDARD_DEVIATION 11.2 • n=7 Participants	58.0 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	11 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	29 Participants n=7 Participants	51 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	37 Participants n=5 Participants	37 Participants n=7 Participants	74 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants	40 participants n=7 Participants	80 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 3 months post nephrectomy

Population: Missing 3 postoperative eGFR from the Traditional Partial Nephrectomy group and 6 from the Off-Clamp Partial Nephrectomy group.

Renal function following nephrectomy with and without clamping will be assessed using: percent change in eGFR from baseline to 3 months post nephrectomy.

Outcome measures

Measure	Off-clamp Partial Nephrectomy n=34 Participants Partial nephrectomy will be performed without clamping of the renal blood vessels. Off-clamp partial nephrectomy	Traditional Partial Nephrectomy n=37 Participants Partial nephrectomy will be performed with clamping of the renal blood vessels.
Percent Change From Baseline in eGFR	-10.7 percent change in eGFR Interval -16.1 to -5.3	-9.4 percent change in eGFR Interval -14.0 to -4.8

PRIMARY outcome

Timeframe: baseline to 3 months post nephrectomy

Population: Missing 1 postoperative renal scan from the Traditional Partial Nephrectomy group and 7 from the Off-Clamp Partial Nephrectomy group.

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.

Outcome measures

Measure	Off-clamp Partial Nephrectomy n=33 Participants Partial nephrectomy will be performed without clamping of the renal blood vessels. Off-clamp partial nephrectomy	Traditional Partial Nephrectomy n=39 Participants Partial nephrectomy will be performed with clamping of the renal blood vessels.
Percent Change From Baseline in Split Renal Function	-11.2 percent change in split renal function Interval -15.9 to -6.5	-11.8 percent change in split renal function Interval -15.9 to -7.7

SECONDARY outcome

Timeframe: at the time of nephrectomy

Population: Only malignant cases were included in the analysis of positive margins.

Oncologic outcomes will be assessed at the time of nephrectomy based on percent of observations with positive surgical margins.

Outcome measures

Measure	Off-clamp Partial Nephrectomy n=32 Participants Partial nephrectomy will be performed without clamping of the renal blood vessels. Off-clamp partial nephrectomy	Traditional Partial Nephrectomy n=34 Participants Partial nephrectomy will be performed with clamping of the renal blood vessels.
Percent of Observations With Positive Surgical Margins.	6.3 percent of cases with positive margins Interval 0.8 to 20.8	5.9 percent of cases with positive margins Interval 0.7 to 19.7

SECONDARY outcome

Timeframe: At the time of nephrectomy

Perioperative outcomes will be assessed based on estimated blood loss at the time of nephrectomy.

Outcome measures

Measure	Off-clamp Partial Nephrectomy n=40 Participants Partial nephrectomy will be performed without clamping of the renal blood vessels. Off-clamp partial nephrectomy	Traditional Partial Nephrectomy n=40 Participants Partial nephrectomy will be performed with clamping of the renal blood vessels.
Estimated Blood Loss	184.1 Milliliters Standard Deviation 193.3	178.5 Milliliters Standard Deviation 207.5

SECONDARY outcome

Timeframe: 3 years

Population: Only malignant cases were included in the analysis of metastasis on follow-up imaging.

Oncologic outcomes will be assessed based on percent of observations with metastasis on follow-up imaging at 3 years post nephrectomy.

Outcome measures

Measure	Off-clamp Partial Nephrectomy n=32 Participants Partial nephrectomy will be performed without clamping of the renal blood vessels. Off-clamp partial nephrectomy	Traditional Partial Nephrectomy n=34 Participants Partial nephrectomy will be performed with clamping of the renal blood vessels.
Percent of Observations With Metastasis	0.0 percent of cases with metastasis on f/u Interval 0.0 to 0.0	2.9 percent of cases with metastasis on f/u Interval 0.1 to 15.3

SECONDARY outcome

Timeframe: At the time of nephrectomy

Perioperative outcomes will be assessed based on operative time measured in minutes at the time of nephrectomy.

Outcome measures

Measure	Off-clamp Partial Nephrectomy n=40 Participants Partial nephrectomy will be performed without clamping of the renal blood vessels. Off-clamp partial nephrectomy	Traditional Partial Nephrectomy n=40 Participants Partial nephrectomy will be performed with clamping of the renal blood vessels.
Operative Time Measured in Minutes.	178.0 Minutes Standard Deviation 44.4	156.0 Minutes Standard Deviation 40.6

SECONDARY outcome

Timeframe: At the time of nephrectomy.

Perioperative outcomes will be assessed based on warm ischemia time measured in minutes at the time of nephrectomy.

Outcome measures

Measure	Off-clamp Partial Nephrectomy n=40 Participants Partial nephrectomy will be performed without clamping of the renal blood vessels. Off-clamp partial nephrectomy	Traditional Partial Nephrectomy n=40 Participants Partial nephrectomy will be performed with clamping of the renal blood vessels.
Warm Ischemia Time Measured in Minutes.	0.0 Minutes Standard Deviation 0.0	19.1 Minutes Standard Deviation 7.5

SECONDARY outcome

Timeframe: At the time of nephrectomy

Perioperative outcomes will be assessed based on percent of observations with intra-operative complications at the time of nephrectomy.

Outcome measures

Measure	Off-clamp Partial Nephrectomy n=40 Participants Partial nephrectomy will be performed without clamping of the renal blood vessels. Off-clamp partial nephrectomy	Traditional Partial Nephrectomy n=40 Participants Partial nephrectomy will be performed with clamping of the renal blood vessels.
Percent of Observations With Intra-operative Complications.	2.5 % of cases with intraop complications Interval 0.1 to 13.2	0.0 % of cases with intraop complications Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Day of nephrectomy to day of hospital discharge.

Perioperative outcomes will be assessed based number of hospital days post nephrectomy.

Outcome measures

Measure	Off-clamp Partial Nephrectomy n=40 Participants Partial nephrectomy will be performed without clamping of the renal blood vessels. Off-clamp partial nephrectomy	Traditional Partial Nephrectomy n=40 Participants Partial nephrectomy will be performed with clamping of the renal blood vessels.
Number of Hospital Days Post Nephrectomy.	1.8 Days Standard Deviation 0.9	1.7 Days Standard Deviation 1.2

SECONDARY outcome

Timeframe: Within 3 months post nephrectomy.

Perioperative outcomes will be assessed based on percent of observations with postoperative complications.

Outcome measures

Measure	Off-clamp Partial Nephrectomy n=40 Participants Partial nephrectomy will be performed without clamping of the renal blood vessels. Off-clamp partial nephrectomy	Traditional Partial Nephrectomy n=40 Participants Partial nephrectomy will be performed with clamping of the renal blood vessels.
Percent of Observations With Postoperative Complications.	20.0 % of cases with postop complications Interval 7.6 to 32.4	17.5 % of cases with postop complications Interval 5.7 to 29.3

Adverse Events

Off-clamp Partial Nephrectomy

Serious events: 2 serious events

Other events: 0 other events

Deaths: 1 deaths

Traditional Partial Nephrectomy

Serious events: 4 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Off-clamp Partial Nephrectomy n=40 participants at risk Partial nephrectomy will be performed without clamping of the renal blood vessels. Off-clamp partial nephrectomy	Traditional Partial Nephrectomy n=40 participants at risk Partial nephrectomy will be performed with clamping of the renal blood vessels.
Respiratory, thoracic and mediastinal disorders acute pulmonary embolism	2.5% 1/40 • Number of events 1 • Adverse event data were collected from time of study intervention to the three-month post nephrectomy visit.	0.00% 0/40 • Adverse event data were collected from time of study intervention to the three-month post nephrectomy visit.
Injury, poisoning and procedural complications postoperative bleeding	2.5% 1/40 • Number of events 1 • Adverse event data were collected from time of study intervention to the three-month post nephrectomy visit.	2.5% 1/40 • Number of events 1 • Adverse event data were collected from time of study intervention to the three-month post nephrectomy visit.
Injury, poisoning and procedural complications pseudoaneurysm	0.00% 0/40 • Adverse event data were collected from time of study intervention to the three-month post nephrectomy visit.	5.0% 2/40 • Number of events 2 • Adverse event data were collected from time of study intervention to the three-month post nephrectomy visit.
Infections and infestations sepsis	0.00% 0/40 • Adverse event data were collected from time of study intervention to the three-month post nephrectomy visit.	2.5% 1/40 • Number of events 1 • Adverse event data were collected from time of study intervention to the three-month post nephrectomy visit.

Other adverse events

Measure	Off-clamp Partial Nephrectomy n=40 participants at risk Partial nephrectomy will be performed without clamping of the renal blood vessels. Off-clamp partial nephrectomy	Traditional Partial Nephrectomy n=40 participants at risk Partial nephrectomy will be performed with clamping of the renal blood vessels.
Renal and urinary disorders urinary retention	0.00% 0/40 • Adverse event data were collected from time of study intervention to the three-month post nephrectomy visit.	5.0% 2/40 • Number of events 2 • Adverse event data were collected from time of study intervention to the three-month post nephrectomy visit.
Infections and infestations fever	0.00% 0/40 • Adverse event data were collected from time of study intervention to the three-month post nephrectomy visit.	2.5% 1/40 • Number of events 1 • Adverse event data were collected from time of study intervention to the three-month post nephrectomy visit.
Injury, poisoning and procedural complications wound dehiscence	0.00% 0/40 • Adverse event data were collected from time of study intervention to the three-month post nephrectomy visit.	2.5% 1/40 • Number of events 1 • Adverse event data were collected from time of study intervention to the three-month post nephrectomy visit.

Additional Information

Manager of Clinical Trials

Washington University School of Medicine

Phone: 3147479781

Email: klima@wustl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place