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Secondary HyperparathyroidismNCT04484116

IOPTH Usefulness for Predicting Successful Surgery in Secondary Hyperparathyroidism

An observational study of Secondary Hyperparathyroidism, run by Hospital General Ajusco Medio at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Secondary Hyperparathyroidism
What is being tested?
Intraoperative Paratohormone
How many people
30 participants
Where
1 siteMexico
Study dates
1 Jul 2017to 30 Nov 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with chronic kidney disease and secondary hyperparathyroidism

Who may be able to join

  • 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

Who cannot join

  • patients who respond adequately to medical treatment
  • incomplete IOPTH protocol

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Hospital General Ajusco Medio

    Mexico City, 14250

Other trials in Mexico

About this study

Official title: 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.

Read the 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.

Being tested
Intraoperative Paratohormone
Keywords
Secondary hyperparathyroidism, Parathyroidectomy, Intraoperative paratohormone
Medical subject headings
Hyperparathyroidism, Secondary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT04484116
Study groupRoleWhat they receive
Succesful surgeryPTH 24 hours after surgery <150pg/mL
Receives: Diagnostic Test: Intraoperative Paratohormone
Unsuccessful surgeryPTH 24 hours after surgery >150pg/mL
Receives: Diagnostic Test: Intraoperative Paratohormone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Successful surgery

    Biochemical response to subtotal prathyroidectomy

    Measured: 24 hours

Secondary outcomes (1)

  1. PTH drop

    Drop from baseline, aiming a drop >70%

    Measured: 15 minutes and 30 minutes after resection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2020
  2. Study start1 Jul 2017
  3. Primary completion30 Nov 2019
  4. Study completion30 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04484116
Sponsor's protocol ID
Not assigned
Status last verified
Jul 2020
First submitted
20 Jul 2020
Last updated
23 Jul 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Pitt SC, Sippel RS, Chen H. Secondary and tertiary hyperparathyroidism, state of the art surgical management. Surg Clin North Am. 2009 Oct;89(5):1227-39. doi: 10.1016/j.suc.2009.06.011.

    PubMed 19836494

  • IV. NKF-K/DOQI Clinical Practice Guidelines for Anemia of Chronic Kidney Disease: update 2000. Am J Kidney Dis. 2001 Jan;37(1 Suppl 1):S182-238. doi: 10.1016/s0272-6386(01)70008-x. No abstract available.

    PubMed 11229970

  • Young EW, Albert JM, Satayathum S, Goodkin DA, Pisoni RL, Akiba T, Akizawa T, Kurokawa K, Bommer J, Piera L, Port FK. Predictors and consequences of altered mineral metabolism: the Dialysis Outcomes and Practice Patterns Study. Kidney Int. 2005 Mar;67(3):1179-87. doi: 10.1111/j.1523-1755.2005.00185.x.

    PubMed 15698460

  • Lorenz K, Bartsch DK, Sancho JJ, Guigard S, Triponez F. Surgical management of secondary hyperparathyroidism in chronic kidney disease--a consensus report of the European Society of Endocrine Surgeons. Langenbecks Arch Surg. 2015 Dec;400(8):907-27. doi: 10.1007/s00423-015-1344-5. Epub 2015 Oct 2.

    PubMed 26429790

  • Carneiro DM, Solorzano CC, Nader MC, Ramirez M, Irvin GL 3rd. Comparison of intraoperative iPTH assay (QPTH) criteria in guiding parathyroidectomy: which criterion is the most accurate? Surgery. 2003 Dec;134(6):973-9; discussion 979-81. doi: 10.1016/j.surg.2003.06.001.

    PubMed 14668730

  • Hruska KA, Korkor A, Martin K, Slatopolsky E. Peripheral metabolism of intact parathyroid hormone. Role of liver and kidney and the effect of chronic renal failure. J Clin Invest. 1981 Mar;67(3):885-92. doi: 10.1172/jci110106.

    PubMed 7204561

  • Hiramitsu T, Tominaga Y, Okada M, Yamamoto T, Kobayashi T. A Retrospective Study of the Impact of Intraoperative Intact Parathyroid Hormone Monitoring During Total Parathyroidectomy for Secondary Hyperparathyroidism: STARD Study. Medicine (Baltimore). 2015 Jul;94(29):e1213. doi: 10.1097/MD.0000000000001213.

    PubMed 26200645

  • Seehofer D, Rayes N, Klupp J, Steinmuller T, Ulrich F, Muller C, Schindler R, Frei U, Neuhaus P. Predictive value of intact parathyroid hormone measurement during surgery for renal hyperparathyroidism. Langenbecks Arch Surg. 2005 Jun;390(3):222-9. doi: 10.1007/s00423-005-0541-z. Epub 2005 Feb 22.

    PubMed 15726399

  • Vulpio C, Bossola M, Di Stasio E, Pepe G, Nure E, Magalini S, Agnes S. Intra-operative parathyroid hormone monitoring through central laboratory is accurate in renal secondary hyperparathyroidism. Clin Biochem. 2016 May;49(7-8):538-43. doi: 10.1016/j.clinbiochem.2016.01.012. Epub 2016 Jan 20.

    PubMed 26800781

  • Lokey J, Pattou F, Mondragon-Sanchez A, Minuto M, Mullineris B, Wambergue F, Foissac-Geroux P, Noel C, de Sagazan HL, VanHille P, Proye CA. Intraoperative decay profile of intact (1-84) parathyroid hormone in surgery for renal hyperparathyroidism--a consecutive series of 80 patients. Surgery. 2000 Dec;128(6):1029-34. doi: 10.1067/msy.2000.110431.

    PubMed 11114639

  • Barczynski M, Cichon S, Konturek A, Cichon W. A randomised study on a new cost-effective algorithm of quick intraoperative intact parathyroid hormone assay in secondary hyperparathyroidism. Langenbecks Arch Surg. 2005 Apr;390(2):121-7. doi: 10.1007/s00423-004-0535-2. Epub 2005 Feb 15.

    PubMed 15711996

Questions about this trial

What is this clinical trial studying?

An observational study of Secondary Hyperparathyroidism, run by Hospital General Ajusco Medio at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Successful surgery (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04484116, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.

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