IOPTH Usefulness for Predicting Successful Surgery in Secondary Hyperparathyroidism

USEFULNESS OF IOPTH AS A PREDICTOR FOR SUCCESSFUL PARATHYROIDECTOMY IN SECONDARY HYPERPARATHYROIDISM: A COHORT STUDY

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04484116

Enrollment

Registered

2020-07-23

Start date

2017-07-01

Completion date

2019-11-30

Last updated

2020-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secondary Hyperparathyroidism

Keywords

Secondary hyperparathyroidism, Parathyroidectomy, Intraoperative paratohormone

Brief summary

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.

Detailed description

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 Three IOPTH determinations were withdrawn: at anesthetic induction (PTH0), 15 minutes (PTH15), and 30 minutes (PTH30) after completion gland resection.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.

Interventions

DIAGNOSTIC_TESTIntraoperative Paratohormone

Three IOPTH determinations were withdrawn: at anesthetic induction (PTH0), 15 minutes (PTH15), and 30 minutes (PTH30) after completion gland resection.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 design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Successful surgery	24 hours	Biochemical response to subtotal prathyroidectomy

Secondary

Measure	Time frame	Description
PTH drop	15 minutes and 30 minutes after resection	Drop from baseline, aiming a drop \>70%

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026