Kidney TransplantationNCT00100516
Donor Recipient Kidney Function Following Open Surgical vs. Laparoscopic Kidney Donation
An observational study of Kidney Transplantation, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Kidney Transplantation
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Dec 2004to 17 Jun 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients enrolled in the Live Donor Renal Donation for Allotransplantation 99-DK-0107.
Who cannot join
- Patients ineligible for this protocol will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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).
Read more
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.
Read the detailed description
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:
- Analyze the effect of varying levels of pneumoperitoneum intraoperatively using infrared imaging;
- 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;
- 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.
- Conditions
- Kidney Transplantation
- Keywords
- Renal, Allografts, Nephrectomy, Pneumoperitoneum, LaparoscopIC, Kidney Donation
- Medical subject headings
- Pneumoperitoneum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2005 (estimated)
- Study start23 Dec 2004
- Study completion17 Jun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 40 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00100516
- Sponsor's protocol ID
- 050043
- Other IDs
- 05-DK-0043
- Status last verified
- 17 Jun 2008
- First submitted
- 31 Dec 2004
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Tarantino A. Why should we implement living donation in renal transplantation? Clin Nephrol. 2000 Apr;53(4):suppl 55-63.
PubMed 10809438
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infrared Image Guided Minimally Invasive Live Donor Kidney Donation for Kidney Transplantation
- ClinicalTrials.gov ID
- NCT00100516
- Acronym / sponsor ID
- 050043
- Conditions
- Kidney Transplantation
- Keywords
- Renal, Allografts, Nephrectomy, Pneumoperitoneum, LaparoscopIC, Kidney Donation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 23 Dec 2004
- Study completion
- 17 Jun 2008
- First posted
- 3 Jan 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Analyze the effect of varying levels of pneumoperitoneum intraoperatively using infrared imaging;
- 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;
- 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.
Study design
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients enrolled in the Live Donor Renal Donation for Allotransplantation 99-DK-0107.
Key exclusion criteria (1 listed)
- Patients ineligible for this protocol will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 10809438Tarantino A. Why should we implement living donation in renal transplantation? Clin Nephrol. 2000 Apr;53(4):suppl 55-63.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00100516, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.