IOPTH Usefulness for Predicting Successful Surgery in Secondary Hyperparathyroidism

Secondary Hyperparathyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04484116
• Other study ID #: Not assigned
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: November 30, 2019

Study information

• Verified date: July 2020
• Source: Hospital General Ajusco Medio
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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 Three IOPTH determinations were withdrawn: at anesthetic induction (PTH0), 15 minutes (PTH15), and 30 minutes (PTH30) after completion gland resection.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Neoplasm Metastasis
• Secondary Hyperparathyroidism

Intervention

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.

Locations

Country	Name	City	State
Mexico	Hospital General Ajusco Medio	Mexico city

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Ajusco Medio

Country where clinical trial is conducted

Mexico, 

References & Publications (11)

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. Epub 2005 Feb 15. — View Citation

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. — View Citation

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). 201 — View Citation

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. — View Citation

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. Erratum in: Am J Kidney Dis 2001 Aug;38(2):442. — View Citation

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 conse — View Citation

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: 1 — View Citation

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. Review. — View Citation

Seehofer D, Rayes N, Klupp J, Steinmüller T, Ulrich F, Müller 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. Epub 20 — View Citation

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.clin — View Citation

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): — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful surgery	Biochemical response to subtotal prathyroidectomy	24 hours
Secondary	PTH drop	Drop from baseline, aiming a drop >70%	15 minutes and 30 minutes after resection