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  • Sixty-Third World Health Assembly, World Health Organization
  • Sixty-Third World Health Assembly
  • World Health Organization
Cell Tissue Bank. 2010 Nov;11(4):413-9 doi: 10.1007/s10561-010-9226-0.

In May 2010, the Sixty-third World Health Assembly Resolution WHA63.22 endorsed the WHO Guiding Principles, updated in the light of changes in practices and attitudes regarding organ and tissue transplantation. The Guiding Principles are intended to provide an orderly, ethical and acceptable framework for the procurement and transplantation of human cells, tissues and organs for therapeutic purposes. Each jurisdiction will determine the means of implementing these WHO Guiding Principles.They preserve the essential points of the 1991 version while incorporating new provisions in response to current trends in transplantation, particularly the protection of the living donor, and the increasing use of human cells and tissues. The Guiding Principles stress the necessity of documentation and transparency, both for quality management purposes and to justify the confidence of patients, clinicians and the community at large in donation and transplantation services.

  • Dols LF
  • Kok NF
  • Terkivatan T
  • Tran TC
  • d'Ancona FC
  • et al.
BMC Surg. 2010 Mar 25;10:11 doi: 10.1186/1471-2482-10-11.
BACKGROUND:

Transplantation is the only treatment offering long-term benefit to patients with chronic kidney failure. Live donor nephrectomy is performed on healthy individuals who do not receive direct therapeutic benefit of the procedure themselves. In order to guarantee the donor's safety, it is important to optimise the surgical approach. Recently we demonstrated the benefit of laparoscopic nephrectomy experienced by the donor. However, this method is characterised by higher in hospital costs, longer operating times and it requires a well-trained surgeon. The hand-assisted retroperitoneoscopic technique may be an alternative to a complete laparoscopic, transperitoneal approach. The peritoneum remains intact and the risk of visceral injuries is reduced. Hand-assistance results in a faster procedure and a significantly reduced operating time. The feasibility of this method has been demonstrated recently, but as to date there are no data available advocating the use of one technique above the other.

METHODS/DESIGN:

The HARP-trial is a multi-centre randomised controlled, single-blind trial. The study compares the hand-assisted retroperitoneoscopic approach with standard laparoscopic donor nephrectomy. The objective is to determine the best approach for live donor nephrectomy to optimise donor's safety and comfort while reducing donation related costs.

DISCUSSION:

This study will contribute to the evidence on any benefits of hand-assisted retroperitoneoscopic versus standard laparoscopic donor nephrectomy.

TRIAL REGISTRATION:

Dutch Trial Register NTR1433.

  • Nicholson ML
  • Kaushik M
  • Lewis GR
  • Brook NR
  • Bagul A
  • et al.
Br J Surg. 2010 Jan;97(1):21-8 doi: 10.1002/bjs.6803.
Aims: To compare the safety and efficacy of short incision open donor nephrectomy without rib resection versus laparoscopic donor nephrectomy.
Interventions: Open donor nephrectomy versus laparoscopic donor nephrectomy. Potential kidney donors and intended transplant recipients attended a 90 minute information session which included a standardized computer presentation describing the risks and benefits of live kidney transplantation and detailed descriptions of the two nephrectomy techniques.
Participants: 84 live kidney donors.
Outcomes: The primary outcome measures were total postoperative morphine requirements and length of hospital stay. Secondary outcome measures in the donors were pain scores, recovery of normal activities and postoperative respiratory function. Secondary outcome measures in the transplant recipients were patient and allograft survival, and renal allograft function measured by serum creatinine level and estimated GFR.
Follow Up: 4 years.
BACKGROUND:

This randomized controlled trial was designed to determine the safety and efficacy of laparoscopic donor nephrectomy (LDN) in comparison with short-incision open donor nephrectomy (ODN).

METHODS:

Eighty-four live kidney donors were randomized in a 2 : 1 ratio to LDN (56 patients) or short-incision ODN without rib resection (28). Primary endpoints were pain relief and duration of inpatient stay.

RESULTS:

There was no donor death or allograft thrombosis in either group. The first warm ischaemic time median (range) 4 (2-7) versus 2 (1-5) min; P = 0.001) and the duration of operation (160 (110-250) versus 150 (90-200); P = 0.004) were longer for LDN. LDN led to a reduction in parenteral morphine requirement 59 (6-136) versus 90 (35-312) mg; P = 0.001) and hospital stay (4 (2-6) versus 6 (2-9) days; P = 0.001), and earlier return to employment (42 (14-84) versus 66.5 (14-112) days; P = 0.004). Postoperative respiratory function was improved after LDN. There were more postoperative complications per donor in the ODN group (0.6(0.7) versus 0.3(0.5); P = 0.033). At a median follow-up of 74 months, there were no differences in renal function or allograft survival between the groups.

CONCLUSION:

LDN removes some of the disincentives to live donation without compromising the outcome of the recipient transplant.

  • Hamidi V
  • Andersen MH
  • Oyen O
  • Mathisen L
  • Fosse E
  • et al.
Transplantation. 2009 Mar 27;87(6):831-8 doi: 10.1097/TP.0b013e318199cfc9.
Aims: To evaluate the quality of life and cost difference between open and laparoscopic nephrectomy in living kidney donors.
Interventions: Open-donor nephrectomy versus laparoscopic living-donor nephrectomy (LLDN).
Participants: 122 living kidney donors.
Outcomes: Operating time, personnel costs, length of stay, cost of analgesic, disposable instruments, complications and indirect costs. Quality of life was measured before the operation and at 1, 6, and 12 months post donation by means of SF-36 questionnaires.
Follow Up: 12 months.
BACKGROUND:

Kidney transplantation is an essential part of care for patients with end-stage renal disease. The introduction of laparoscopic living-donor nephrectomy (LLDN) has made live donation more advantageous because of less postoperative pain, earlier return to normal activities, and a consequent potential to increase the pool of kidney donors. However, the cost effectiveness of LLDN remains unknown. The aim of this study was to explore the health and cost consequences of replacing open-donor nephrectomy by LLDN.

METHODS:

Kidney donors were randomized to laparoscopic (n=63) or open surgery (n=59). We obtained data on operating time, personnel costs, length of stay, cost of analgesic, disposable instruments and complications, and indirect costs. Quality of life was captured before the operation and at 1, 6, and 12 months postdonation by means of short form-36. The scores were translated into utilities by means of Brazier's 6D algorithm.

RESULTS:

The cost per patient was U.S. $55,292 with laparoscopic and U.S. $29,886 with open surgery. The greatest cost difference was in costs attributed to complications (U.S. $33,162 vs. U.S. $4,573). The 1-year quality-adjusted life years (QALYs) were 0.780 and 0.765, respectively for laparoscopic and open surgery. This implies a cost of U.S. $1,693,733 per QALY at 12 months follow-up. Sensitivity analyses indicated that the cost of the major complications in the laparoscopic group and magnitude of QALY gain had the greatest impact on cost effectiveness.

CONCLUSIONS:

The LLDN is an attractive alternative because it, in general, entails less postoperative pain than open surgery, but it is cost effective only with relatively low rates of complications.

  • International Summit on Transplant Tourism and Organ Trafficking
  • The Transplantation Society
  • International Society of Nephrology
Clin J Am Soc Nephrol. 2008 Sep;3(5):1227-31 doi: 10.2215/CJN.03320708.

Organ commercialism, which targets vulnerable populations (such as illiterate and impoverished persons, undocumented immigrants, prisoners, and political or economic refugees) in resource-poor countries, has been condemned by international bodies such as the World Health Organization for decades. Yet in recent years, as a consequence of the increasing ease of Internet communication and the willingness of patients in rich countries to travel and purchase organs, organ trafficking and transplant tourism have grown into global problems. For example, as of 2006, foreigners received two-thirds of the 2000 kidney transplants performed annually in Pakistan. The Istanbul Declaration proclaims that the poor who sell their organs are being exploited, whether by richer people within their own countries or by transplant tourists from abroad. Moreover, transplant tourists risk physical harm by unregulated and illegal transplantation. Participants in the Istanbul Summit concluded that transplant commercialism, which targets the vulnerable, transplant tourism, and organ trafficking should be prohibited. And they also urged their fellow transplant professionals, individually and through their organizations, to put an end to these unethical activities and foster safe, accountable practices that meet the needs of transplant recipients while protecting donors. Countries from which transplant tourists originate, as well as those to which they travel to obtain transplants, are just beginning to address their respective responsibilities to protect their people from exploitation and to develop national self-sufficiency in organ donation. The Declaration should reinforce the resolve of governments and international organizations to develop laws and guidelines to bring an end to wrongful practices. "The legacy of transplantation is threatened by organ trafficking and transplant tourism. The Declaration of Istanbul aims to combat these activities and to preserve the nobility of organ donation. The success of transplantation as a life-saving treatment does not require-nor justify-victimizing the world's poor as the source of organs for the rich" (Steering Committee of the Istanbul Summit).

  • Rodrigue JR
  • Cornell DL
  • Kaplan B
  • Howard RJ
Prog Transplant. 2008 Mar;18(1):25-31 doi: 10.1177/152692480801800107.
BACKGROUND:

Living donor kidney transplantation has several advantages for patients with end-stage renal disease. However, many patients are reluctant to pursue this treatment option, preferring instead to wait for a deceased donor organ.

OBJECTIVE:

To examine predictors of patients' willingness to talk to others about living kidney donation.

METHODS:

One hundred thirty-two adult patients awaiting kidney transplantation who were enrolled in a randomized trial examining the effectiveness of education on rates of live donor kidney transplantation completed a baseline rating of their willingness to talk to others about living kidney donation. Also, patients completed measures of knowledge and concerns about living donation and a rating of perceived health.

RESULTS:

Slightly more than half the patients (56.1%) had low willingness to talk to others about living donation. The following variables were associated with higher willingness to talk to others: white race (odds ratio, 3.31; confidence interval, 1.7-7.4), college education (odds ratio, 3.43, confidence interval, 2.0-5.6), fewer concerns about living donor kidney transplantation (odds ratio, 0.31; confidence interval, 0.2-0.6), and less favorable perceptions of their current health status (odds ratio, 4.31; confidence interval, 2.6-7.6).

CONCLUSION:

White race, more education, less concern about living donor kidney transplantation, and poorer perceived health are associated with greater willingness to talk to others about living kidney donation. These findings have important implications for educating patients about living donor kidney transplantation.

  • Kranenburg L
  • Zuidema W
  • Erdman R
  • Weimar W
  • Passchier J
  • et al.
Psychol Med. 2008 Feb;38(2):177-85 doi: 10.1017/S0033291707000979.
BACKGROUND:

Living kidney donation to a loved one has become common practice. Another type of living donation that is becoming more acceptable to the transplant community is 'Samaritan donation'. Samaritan kidney donors are willing to donate to patients they do not know. Until recently there has been great reluctance to accept the offers of Samaritan donors because it was feared that these donors might be mentally unstable.

METHOD:

The purpose of this article is to review the literature about the psychological evaluation of potential Samaritan kidney donors for donor suitability. We have performed a systematic literature search in Pubmed, ISI Web of Science and PsycINFO. We compare and discuss how each study approaches the question about Samaritan donor selection. In addition, we have also screened the studies for reports of rejections of Samaritan donors on psychological grounds.

RESULTS:

We have found five articles that at least in some detail describe the evaluation of potential Samaritan donors. For all five articles found, a consultation with either a psychiatrist or a psychologist formed a standard part of the donor evaluation procedure. This evaluation consisted of an interview, and in most instances, additional psychometric testing. According to the articles found, the two major criteria for donor rejection were psychopathology/psychological instability and motivational issues. Three studies reported on the rejection of potential donors on psychological grounds.

CONCLUSIONS:

The evaluation of Samaritan kidney donors is a developing field in clinical medicine. Given the relatively low incidence of these types of donations, we recommend the exchange of experience between centres that run a Samaritan donor programme, in order to improve donor evaluation criteria.

  • National Working Group Kidney Transplantation
  • Landelijk Overleg Niertransplantatie
  • Dutch Transplant Society
  • Nederlandse Transplantatie Vereniging
  • Homan van der Heide JJ
transplantatievereniging.nl. 2008.
  • Andersen MH
  • Mathisen L
  • Veenstra M
  • Oyen O
  • Edwin B
  • et al.
Transplantation. 2007 Jul 15;84(1):64-9 doi: 10.1097/01.tp.0000268071.63977.42.
BACKGROUND:

The aim of this randomized study was to compare patient-reported outcome after laparoscopic versus open donor nephrectomy during 1 year follow-up. The evidence base has so far not allowed for a decision as to which method is superior as seen from a long-term quality of life-perspective.

METHODS:

The donors were randomized to laparoscopic (n=63) or open (n=59) nephrectomy, with follow-up at 1, 6, and 12 months. Primary outcomes were health status (SF-36) and overall quality of life (QOLS-N). Secondary outcomes were donor perception of the surgical scar, the donation's impact on personal finances, and whether the donor would make the same decision to donate again.

RESULTS:

There was a significant difference in favor of laparoscopic surgery regarding the SF-36 subscale bodily pain at 1 month postoperatively (P<0.05). Analysis based on intention to treat revealed no long-term differences between groups in SF-36 scores. When subtracting the reoperated/converted donors of the laparoscopic group, significant differences in favor of laparoscopy were revealed in the subscales bodily pain at 6 months (P<0.05) and social functioning at 12 months (P<0.05). No significant differences were found in QOLS-N scores between groups.

CONCLUSIONS:

Laparoscopic donor nephrectomy is an attractive alternative to open donor nephrectomy because of less postoperative pain. However, long-term comparison only revealed significant differences in favor of laparoscopy when adjusting for reoperations/conversions. Both groups reached baseline scores in most SF-36 subscales at 12 months and this may explain why possible minor benefits are hard to prove.

  • Ardalan MR
  • Maljaei H
  • Shoja MM
  • Piri AR
  • Khosroshahi HT
  • et al.
Transplant Proc. 2007 May;39(4):951-3 doi: 10.1016/j.transproceed.2007.04.012.
OBJECTIVES:

Alloreactive T cells recognize antigens via direct and indirect pathways. The competency of costimulatory molecules on antigen-presenting cells (APC) is important. An active form of vitamin D (1,25(OH)(2)D(3), calcitriol) inhibits APC cell maturation and expression of costimulatory molecules. Herein we studied the immunosuppressive effects of calcitriol, which was started in the donors and continued in the kidney recipients.

METHODS:

In this prospective study, candidates for living donor renal transplantation were randomly assigned into two groups: the treatment group were prescribed calcitriol (0.5 microg/day) started in the donor 6 days before donation and continued in recipient side for 6 months after transplantation. The control group received the conventional immunosuppressive regimen, namely, cyclosporine/mycophenolate mofetil and prednisolone. In each group, a recipient blood sample was obtained before and 6 months after transplantation. Diagnostic study of the T-cell markers-CD3, CD4, and CD25-were performed with a flow cytometry technique.

RESULTS:

The mean values of CD3(+)CD4(+)CD25(+) T cells in the treatment group (four women and five men; 40.8 +/- 8.5 years) and the control group (four women and six men; 37.2 +/- 10 years) were at 14.2 +/- 4.2% and 15.4 +/- 4.5% of total peripheral lymphocytes. Six months after transplantation, these percentages increased to 29 +/- 6.3% in the treatment group and decreased to 12.1 +/- 4.5% in the controls (P<.0001). No clinical rejection was detected in either group during the study period.

CONCLUSION:

Calcitriol started in the donors and continued in the kidney allograft recipients lead to expansion of CD4(+)CD25(+) regulatory T cells in recipients. We speculated that costimulatory deficient APC for both direct and in-direct pathways may play a role.