Kidney Transplantation Clinical Trial
Official title:
Infrared Image Guided Minimally Invasive Live Donor Kidney Donation for Kidney Transplantation
This study will evaluate the differences between open surgical kidney donation and
laparoscopic kidney donation on kidney donors and recipients. Both procedures are standard
surgeries used to remove kidneys for donation, and they are done equally often. Open surgical
kidney donation involves removing the donor kidney through a 3- to 5-inch surgical incision.
Laparoscopic donation involves making several small holes in the skin and removing the kidney
through a larger hole, while directly watching the kidney with a camera. The study will
correlate the effects of both procedures with donor and recipient kidney function, urine
output, post-operative pain, and return to work after surgery.
Adults without kidney disease who are willing to donate a kidney to a patient enrolled in a
clinical transplant protocol at the NIH Clinical Center may be eligible for this study.
Donors and recipients must be enrolled in the NIDDK protocol, Live Donor Renal Donation for
Allotransplantation (protocol #99-DK-0107).
Donors and patients undergo the following procedures:
- Infrared imaging (measurement of small differences in temperature using a special
camera) during surgery to look at blood flow to the kidney during the operation (both
donor and recipient surgical procedures). The pictures provide images of the blood
vessels in the kidney and measure how the blood flow changes.
- Kidney biopsy (removal of a small piece of kidney tissue). The patient's failed kidney
is biopsied once during transplant surgery when it is removed. The donor's kidney is
biopsied twice - once during surgery to remove the organ from the donor and again after
transplant into the recipient.
- Evaluations after surgery of post-operative urine output, blood pressure, and pain, and
length of hospital stay and return to work.
Laparoscopic techniques are increasingly being used for live donor nephrectomy for kidney
transplantation. The technical methods have been rapidly adopted by the transplant community,
but remain limited by the requirement for pneumoperitoneum, a technique that increases
intra-abdominal pressure to gain surgical exposure. Pneumoperitoneum reduces renal cortical
blood flow, potentially inducing ischemia associated factors that promote allograft rejection
or attenuate post transplant renal function.
The aim of this study is to determine the effects of pneumoperitoneum used for minimally
invasive donor nephrectomy on renal perfusion using infrared imaging. Our goals are to:
1. Analyze the effect of varying levels of pneumoperitoneum intraoperatively using infrared
imaging;
2. Correlate the effects of both open and laparoscopic living donation with respect to
transcriptional events, donor and recipient renal function, urine output, post-operative
pain and return to work postoperatively;
3. Determine optimal conditions for procurement of renal allografts for subjects undergoing
renal transplantation.
In this study, patients will be those who have been consented to kidney donation on the Live
Donor Renal Donation for Allotransplantation (99-DK-0107). This study will represent the
first such use of infrared imaging and the first prospective evaluation of strategies for
living kidney donation.
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