IOPTH Usefulness for Predicting Successful Surgery in Secondary Hyperparathyroidism

July 20, 2020 updated by: Karla Verónica Chavez-Tostado, Hospital General Ajusco Medio

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Three IOPTH determinations were withdrawn: at anesthetic induction (PTH0), 15 minutes (PTH15), and 30 minutes (PTH30) after completion gland resection.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

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico city, Mexico, 14250
        • Hospital General Ajusco Medio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic kidney disease and secondary hyperparathyroidism

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Succesful surgery
PTH 24 hours after surgery <150pg/mL
Diagnostic test: Intraoperative 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.
Unsuccessful surgery
PTH 24 hours after surgery >150pg/mL
Diagnostic test: Intraoperative 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful surgery
Time Frame: 24 hours
Biochemical response to subtotal prathyroidectomy
24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Ajusco Medio

Investigators

  • Principal Investigator: Karla V Chavez-Tostado, MD, SEDESA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Actual)

November 30, 2019

Study Completion (Actual)

November 30, 2019

Study Registration Dates

First Submitted

July 20, 2020

First Submitted That Met QC Criteria

July 20, 2020

First Posted (Actual)

July 23, 2020

Study Record Updates

Last Update Posted (Actual)

July 23, 2020

Last Update Submitted That Met QC Criteria

July 20, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Not assigned (Charles A. Dana Foundation Brain and Immuno-Imaging Grant)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Secondary Hyperparathyroidism

Clinical Trials on Intraoperative Paratohormone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe