Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06187480 |
| Other study ID # |
E-78017789-050.01.04-1638902 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2021 |
| Est. completion date |
January 1, 2023 |
Study information
| Verified date |
December 2023 |
| Source |
Mersin University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This study aims to investigate the changes in cardiac functions, especially myocardial
performance index (MPI), in patients who underwent parathyroidectomy for secondary
hyperparathyroidism.
Participants who underwent parathyroidectomy for secondary hyperparathyroidism between June
2010 and September 2021 were analyzed retrospectively. The participants were divided into two
groups: those who underwent total parathyroidectomy (group 1) and those who underwent
subtotal parathyroidectomy (group 2). The groups were compared according to the
echocardiogram findings performed in the preoperative period and the postoperative sixth
month. In addition, cardiac structure, systolic and diastolic function, especially myocardial
performance index, were evaluated by echocardiography and Doppler imaging.
Description:
Patient selection
The participants who developed secondary hyperparathyroidism after chronic renal failure and
underwent subtotal/total parathyroidectomy in our hospital between June 2010 and September
2021 were analyzed with a single-center Nested case-control study design.
Patients with a diagnosis of chronic renal failure, secondary hyperthyroidism after chronic
renal failure, preoperative and postoperative laboratory tests, parathyroidectomy operation,
and preoperative and postoperative 6-month transthoracic echocardiography (ECHO) were
included in the study.
Advanced-stage lung disease, atrial fibrillation, atrial and supraventricular tachycardia,
extra ventricular beats, intraventricular conduction disorders, ventricular pacing, moderate
to severe valve pathology, history of bypass surgery, poor image quality in transthoracic
echocardiography as cardiac comorbidities Patients with disease and missing data were
excluded from the study.
Data collection
Demographic data (age, gender), surgery (total/subtotal parathyroidectomy) preoperative and
postoperative laboratory analyses, and ECHO reports of the patients were recorded. In
laboratory values, glucose, hemoglobin, albumin, blood urea nitrogen (BUN), creatinine,
calcium, phosphorus, and parathormone values were recorded. In ECHO reports, left ventricular
end-diastolic diameter (cm), left ventricular end-systolic diameter (cm), left ventricular
end-diastolic septum thickness (cm), left ventricular end-diastolic posterior wall thickness
(cm), ejection fraction (%), fractional shortening, end-diastolic volume, end-systolic
volume, ejection volume, isovolumetric relaxation time (IVRT), isovolumetric contraction time
(IVCT), ejection time (ET) and myocardial performance index (MPI) data were recorded.
Surgical Technique
Patients resistant to calcimimetics and vitamin D analogs, patients with symptoms such as
bone and joint pain, persistent itching, and muscle aches, and patients whose symptoms affect
their quality of life are among the indications for surgery. In addition, parathyroidectomy
was performed on patients with uncontrolled hyperphosphatemia, anemia hyporesponsive to
erythropoietin therapy, hypercalcemia, and vascular and tissue calcifications, considered
complications of SHPT.
Subtotal or total parathyroidectomy is performed in the SHPT. Total parathyroidectomy was
performed without autotransplantation to prevent recurrent resistant SHPT in patients with
long life expectancy and little or no possibility of kidney transplantation. In the
preoperative period, routine ultrasound and 99mTc-sestamibi scintigraphy were performed on
the patients. During neck exploration, tissues considered the parathyroid gland were examined
as a frozen section. As a result of the frozen section, it was confirmed how many glands were
removed. After parathyroidectomy was completed, intraoperative parathormone testing was
performed in all patients, and it was observed that parathormone levels decreased. In the
subtotal parathyroidectomy procedure, four parathyroid glands are explored. Usually, half of
the parathyroid gland, closest to normal in appearance and size, is left in place with its
vascular network. Other glands are excised. In the total parathyroidectomy procedure, four
parathyroid glands are explored and excised. Then, a part of the parathyroid gland closest to
normal in appearance and size is auto-transplanted into the sternoclaidomastoid muscle or the
forearm. The transplantation area is marked with a metal clip.
Echocardiography (ECHO)
All patients were evaluated with two-dimensional, pulse-wave Doppler and tissue Doppler
echocardiography. Philips HD11 XE device was used to detect echocardiographic data.
Parasternal long axis view with M-Mode echocardiography method left ventricular
interventricular septum thickness, left ventricular posterior wall thickness, left
ventricular end-diastolic diameter, left ventricular end-systolic diameter, left ventricular
end-diastolic volume, left ventricular end-systolic volume, left ventricular end-systolic
volume, and fractional shortening data were determined. In addition, left ventricular stroke
volume was determined by subtracting the left ventricular end-systolic volume from the left
ventricular end-diastolic volume.
Myocardial performance index calculation technique
The myocardial performance index (MPI) is a numerical value obtained using cardiac time
intervals. This numerical value was obtained by dividing the sum of isovolumetric contraction
time (ICT) and isovolumetric relaxation time (IRT) by ejection time (ET). MPI can be detected
using conventional Pulse-wave Doppler or tissue Doppler echocardiography. The mean average
left ventricular (LV) MPI value is 0.39 ± 0.05. In adults, LV MPI values less than 0.40 are
considered normal. Higher index values are associated with cardiac dysfunction.
Our study obtained cardiac time intervals using Pulsed wave Doppler echocardiography
techniques. MPI, Pulsed wave Doppler echocardiography from the apical four-chamber images, by
placing the sample volume at the endpoints of the mitral valves, the time interval between
the end and the beginning of the mitral flow (a), switching to the apical five-chamber images
and placing the sample volume in the left ventricular outflow tract just below the aortic
valves to determine the left ventricular ET (b) was done. The left ventricular isovolumetric
(ICT+IRT) sum was calculated by subtracting left ventricular ET from the time interval
between the end and beginning of mitral flow (a-b). Thus, MPI [(a-b)/b] was obtained.
Statistical analysis
Mean and standard deviation were used for the statistics of continuous data. Median, minimum,
and maximum values were used for continuous or ordinal data that did not show normal
distribution. Frequency (n) and percentage (%) values were used to define categorical
variables. Fisher's exact test was used to compare the means of two independent groups. The
chi-square test was used to evaluate the relationship between categorical variables. Paired
t-test was used to compare the patient's preoperative and postoperative numerical data. The
statistical significance level of the data was taken as p<0.05. The statistical program
www.e-picos.com was used to evaluate the data.
