IOPTH Usefulness for Predicting Successful Surgery in Secondary Hyperparathyroidism

Hospital General Ajusco Medio30 enrolled

Overview

Secondary hyperparathyroidism (SHPT) is a multisystemic syndrome that affects calcium and bone homeostasis in patients with chronic kidney disease (CKD). Despite medical treatment, 1-2% of patients require parathyroidectomy anually. The use of an intraoperative paratohormone protocol (IOPTH) to predict cure still in debate, due to the lack of standardized protocols, the use of different assays and uneven PTH clearance. The aim of this study was to determine the diagnostic accuracy of an IOPTH in patients with SHPT for predicting successful surgery after parathyroidectomy.

A prospective observational study (cohort) was performed in patients who were submitted to parathyroidectomy by an endocrine surgeon for SHPT. All were submitted to a bilateral neck exploration with a subtotal parathyroidectomy. Three IOPTH determinations were withdrawn: at anesthetic induction (PTH0), 15 minutes (PTH15), and 30 minutes (PTH30) after completion gland resection. Another sample was taken 24 hours after the procedure (PTH24), values \<150pg/mL defined a successful surgery and patients were assigned to the successful or unsuccessful group. IOPTH drop was analyzed to predict successful surgery with drops of 70% and 90% at 15 and 30 minutes.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Secondary Hyperparathyroidism

Interventions

Intraoperative ParatohormoneDIAGNOSTIC_TEST

Three IOPTH determinations were withdrawn: at anesthetic induction (PTH0), 15 minutes (PTH15), and 30 minutes (PTH30) after completion gland resection. Another sample was taken 24 hours after the procedure (PTH24), values \<150pg/mL defined a successful surgery and patients were assigned to the successful or unsuccessful group. IOPTH drop was analyzed to predict successful surgery with drops of 70% and 90% at 15 and 30 minutes.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * PTH \>800pg/mL and SHPT symptoms, or * Asymptomatic patients with PTH \>1000pg/mL who were resistant to treatment * compliance with the signature of the informed consent Exclusion Criteria: * patients who respond adequately to medical treatment * incomplete IOPTH protocol

Locations (1)

Hospital General Ajusco Medio

Mexico City, Mexico

Outcomes

Primary Outcomes

Successful surgery

Biochemical response to subtotal prathyroidectomy

Time frame: 24 hours

Secondary Outcomes

PTH drop

Drop from baseline, aiming a drop \>70%

Time frame: 15 minutes and 30 minutes after resection

Data from ClinicalTrials.gov

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