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Completed

NCT Number: NCT04484116

IOPTH Usefulness for Predicting Successful Surgery in Secondary Hyperparathyroidism

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.

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Key information

Conditions

Secondary Hyperparathyroidism Endocrine System Diseases Hyperparathyroidism Hyperparathyroidism, Secondary Parathyroid Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital General Ajusco Medio

Mexico City, 14250, Mexico

About this study

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 Three IOPTH determinations were withdrawn: at anesthetic induction (PTH0), 15 minutes (PTH15), and 30 minutes (PTH30) after completion gland resection.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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraoperative Paratohormone

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Three IOPTH determinations were withdrawn: at anesthetic induction (PTH0), 15 minutes (PTH15), and 30 minutes (PTH30) after completion gland resection.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

Primary outcomes

  1. Successful surgery

    Time frame: 24 hours

    Biochemical response to subtotal prathyroidectomy

Secondary outcomes

  1. PTH drop

    Time frame: 15 minutes and 30 minutes after resection

    Drop from baseline, aiming a drop >70%

Sponsors and collaborators

Lead sponsor

Hospital General Ajusco Medio

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 23, 2020
Registry last updated
Jul 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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