Addison Disease Clinical Trial
Official title:
Prospective Evaluation of Adrenal Function After Living Donor Nephrectomy With or Without Ligation of the Adrenal Vein
The success of kidney transplantation is hampered by the shortage of organs. One attractive
strategy is the use of kidneys from living donors. During the donor operation the kidney
artery, kidney vein and ureter have to be interrupted as far as possible from the kidney to
have sufficient length for the reconnection of these structures in the transplant operation.
An adrenal gland is situated at the upper pole of each kidney. While the arterial supply is
accomplished by many small vessels, the venous drainage is only through one vein. On the
right side the adrenal vein empties directly into the inferior vena cava (the large vessel
transporting blood from the lower body to the heart). In contrast, on the left side the
adrenal vein empties into the kidney vein, which in turn drains to the inferior vana cava.
Due to these anatomical differences a left-sided removal of a kidney always necessitates an
interruption of the left adrenal vein, while a right-sided kidney removal does not.
As the venous drainage of the left adrenal gland is closed during living kidney donation,
the gland is most likely functionally impaired. This can be compared to a right-sided kidney
donation, where the adrenal vein is left intact. These comparisons are performed by adrenal
function tests before, one week after and one month after kidney donation. These function
tests consist of blood values drawn after stimulation with a hormone drug.
Due the lack of suitable donor organs a large proportion of kidney transplantations is now
performed from living donors. In the year 2002 the number of living donors surpassed the
number of cadaveric donors in Switzerland (Swisstransplant, Swiss Transplant Society 2005).
Kidney grafts from living donors have superior long-term outcome (Hariharan S, N Engl J Med
2000). At the University Hospital Zurich 28 of the 84 kidney transplantations performed in
the year 2004 were from living donors.
During living donor nephrectomy the renal artery and renal vein are transected as far away
from the kidney as possible, to ensure an adequate vessel length for the subsequent
transplantation procedure. The arterial supply of the adrenal glands is accomplished by
several small vessels (ca. 5-15), while the venous drainage is usually dependent on a single
vein. While the right-sided adrenal vein drains directly into the inferior vena cava (IVC),
the left-sided adrenal vein drains into the renal vein. Variants are relatively rare and
occur in 5% of cases (Sebe P, Surg Radiol Anat 2002). Therefore, during donor nephrectomy of
the left kidney the adrenal vein is transected, while this is not necessary on the right
side.
The question addressed in this clinical trial is whether left-sided donor nephrectomy
affects the left adrenal gland. This might be compensated immediately by the contralateral
gland or it might lead to a measurable functional adrenal deficit. Such an adrenal
insufficiency could be detrimental to the immediate postoperative course. The
intermediate-term outcome of the adrenal glands is also of interest, as an impairment of the
left adrenal gland will lead to a hypertrophy of the contralateral gland.
Few scientific publications have addressed these questions. There are case reports of acute
intra- and postoperative adrenal insufficiency in patients undergoing nephrectomy with
adrenalectomy (Cassinello Ogea C, Rev Esp Anestesiol Reanim 2002, Henrich WL, Urology 1976,
Messiant F, Ann Fr Anesth Reanim 1993, Safir MH, Geriatr Nephrol Urol 1998). A small
prospective study in patients undergoing radical nephrectomy (including adrenalectomy) did
not find signs of adrenal insufficiency (Bischoff P, Anaesthesist 1997). However a subgroup
analysis of a newer study demonstrated adrenal insufficiency in radical versus
adrenal-sparing nephrectomy (Yokoyama H, BJU Int 2005).
The study hypothesis is that left-sided donor nephrectomy (i.e. with transaction of the
adrenal vein) is deleterious to the left adrenal gland and causes a measurable transient
adrenal insufficiency after the operation. The primary study endpoint is the assessment of
adrenal function after donor nephrectomy. This is done by an ACTH stimulation test,
performed at baseline, in the first week after the operation and 4 weeks after the
operation. Comparisons are performed between baseline and postoperative values, as well as
between left-sided kidney donors (n=20) and right-sided kidney donors (n=10). A secondary
study endpoint is to assess the morphological response of both adrenal glands after donor
nephrectomy. To this end MRI and volumetry of the adrenal glands is performed at the same
time points, with the hypothesis that left-sided nephrectomy will lead to an involution of
the left adrenal followed by hypertrophy of the right adrenal.
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Observational Model: Cohort, Time Perspective: Prospective
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