<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04484116</url>
  </required_header>
  <id_info>
    <org_study_id>Not assigned</org_study_id>
    <nct_id>NCT04484116</nct_id>
  </id_info>
  <brief_title>IOPTH Usefulness for Predicting Successful Surgery in Secondary Hyperparathyroidism</brief_title>
  <official_title>USEFULNESS OF IOPTH AS A PREDICTOR FOR SUCCESSFUL PARATHYROIDECTOMY IN SECONDARY HYPERPARATHYROIDISM: A COHORT STUDY</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital General Ajusco Medio</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital General Ajusco Medio</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Secondary hyperparathyroidism (SHPT) is a multisystemic syndrome that affects calcium and&#xD;
      bone homeostasis in patients with chronic kidney disease (CKD). Despite medical treatment,&#xD;
      1-2% of patients require parathyroidectomy anually. The use of an intraoperative&#xD;
      paratohormone protocol (IOPTH) to predict cure still in debate, due to the lack of&#xD;
      standardized protocols, the use of different assays and uneven PTH clearance. The aim of this&#xD;
      study was to determine the diagnostic accuracy of an IOPTH in patients with SHPT for&#xD;
      predicting successful surgery after parathyroidectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective observational study (cohort) was performed in patients who were submitted to&#xD;
      parathyroidectomy by an endocrine surgeon for SHPT. All were submitted to a bilateral neck&#xD;
      exploration with a subtotal parathyroidectomy. Three IOPTH determinations were withdrawn: at&#xD;
      anesthetic induction (PTH0), 15 minutes (PTH15), and 30 minutes (PTH30) after completion&#xD;
      gland resection. Another sample was taken 24 hours after the procedure (PTH24), values&#xD;
      &lt;150pg/mL defined a successful surgery and patients were assigned to the successful or&#xD;
      unsuccessful group. IOPTH drop was analyzed to predict successful surgery with drops of 70%&#xD;
      and 90% at 15 and 30 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">November 30, 2019</completion_date>
  <primary_completion_date type="Actual">November 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Successful surgery</measure>
    <time_frame>24 hours</time_frame>
    <description>Biochemical response to subtotal prathyroidectomy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PTH drop</measure>
    <time_frame>15 minutes and 30 minutes after resection</time_frame>
    <description>Drop from baseline, aiming a drop &gt;70%</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Secondary Hyperparathyroidism</condition>
  <arm_group>
    <arm_group_label>Succesful surgery</arm_group_label>
    <description>PTH 24 hours after surgery &lt;150pg/mL</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Unsuccessful surgery</arm_group_label>
    <description>PTH 24 hours after surgery &gt;150pg/mL</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Intraoperative Paratohormone</intervention_name>
    <description>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 &lt;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.</description>
    <arm_group_label>Succesful surgery</arm_group_label>
    <arm_group_label>Unsuccessful surgery</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with chronic kidney disease and secondary hyperparathyroidism&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  PTH &gt;800pg/mL and SHPT symptoms, or&#xD;
&#xD;
          -  Asymptomatic patients with PTH &gt;1000pg/mL who were resistant to treatment&#xD;
&#xD;
          -  compliance with the signature of the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who respond adequately to medical treatment&#xD;
&#xD;
          -  incomplete IOPTH protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karla V Chavez-Tostado, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>SEDESA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital General Ajusco Medio</name>
      <address>
        <city>Mexico city</city>
        <zip>14250</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <results_reference>
    <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.</citation>
    <PMID>19836494</PMID>
  </results_reference>
  <results_reference>
    <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. doi: 10.1016/s0272-6386(01)70008-x. No abstract available. Erratum In: Am J Kidney Dis 2001 Aug;38(2):442.</citation>
    <PMID>11229970</PMID>
  </results_reference>
  <results_reference>
    <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):1179-87. doi: 10.1111/j.1523-1755.2005.00185.x.</citation>
    <PMID>15698460</PMID>
  </results_reference>
  <results_reference>
    <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: 10.1007/s00423-015-1344-5. Epub 2015 Oct 2.</citation>
    <PMID>26429790</PMID>
  </results_reference>
  <results_reference>
    <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. doi: 10.1016/j.surg.2003.06.001.</citation>
    <PMID>14668730</PMID>
  </results_reference>
  <results_reference>
    <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. doi: 10.1172/jci110106.</citation>
    <PMID>7204561</PMID>
  </results_reference>
  <results_reference>
    <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). 2015 Jul;94(29):e1213. doi: 10.1097/MD.0000000000001213. Erratum In: Medicine (Baltimore). 2015 Aug;94(32):1.</citation>
    <PMID>26200645</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>15726399</PMID>
  </results_reference>
  <results_reference>
    <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.clinbiochem.2016.01.012. Epub 2016 Jan 20.</citation>
    <PMID>26800781</PMID>
  </results_reference>
  <results_reference>
    <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 consecutive series of 80 patients. Surgery. 2000 Dec;128(6):1029-34. doi: 10.1067/msy.2000.110431.</citation>
    <PMID>11114639</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>15711996</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital General Ajusco Medio</investigator_affiliation>
    <investigator_full_name>Karla Verónica Chavez-Tostado</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Secondary hyperparathyroidism</keyword>
  <keyword>Parathyroidectomy</keyword>
  <keyword>Intraoperative paratohormone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Hyperparathyroidism</mesh_term>
    <mesh_term>Hyperparathyroidism, Secondary</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04484116
org study id: Not assigned
nct id: NCT04484116
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Successful surgery
time frame: 24 hours
description: Biochemical response to subtotal prathyroidectomy
measure: PTH drop
time frame: 15 minutes and 30 minutes after resection
description: Drop from baseline, aiming a drop >70%
arm group label: Succesful surgery
description: PTH 24 hours after surgery <150pg/mL
arm group label: Unsuccessful surgery
description: PTH 24 hours after surgery >150pg/mL
intervention type: Diagnostic Test
intervention name: Intraoperative Paratohormone
description: 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.
arm group label: Succesful surgery
arm group label: Unsuccessful surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Karla V Chavez-Tostado, MD
role: Principal Investigator
affiliation: SEDESA
facility: 
country: Mexico
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.
PMID: 19836494
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. doi: 10.1016/s0272-6386(01)70008-x. No abstract available. Erratum In: Am J Kidney Dis 2001 Aug;38(2):442.
PMID: 11229970
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):1179-87. doi: 10.1111/j.1523-1755.2005.00185.x.
PMID: 15698460
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: 10.1007/s00423-015-1344-5. Epub 2015 Oct 2.
PMID: 26429790
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. doi: 10.1016/j.surg.2003.06.001.
PMID: 14668730
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. doi: 10.1172/jci110106.
PMID: 7204561
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). 2015 Jul;94(29):e1213. doi: 10.1097/MD.0000000000001213. Erratum In: Medicine (Baltimore). 2015 Aug;94(32):1.
PMID: 26200645
citation: 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.
PMID: 15726399
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.clinbiochem.2016.01.012. Epub 2016 Jan 20.
PMID: 26800781
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 consecutive series of 80 patients. Surgery. 2000 Dec;128(6):1029-34. doi: 10.1067/msy.2000.110431.
PMID: 11114639
citation: 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.
PMID: 15711996
responsible party type: Principal Investigator
investigator affiliation: Hospital General Ajusco Medio
investigator full name: Karla Verónica Chavez-Tostado
investigator title: MD
mesh term: Neoplasm Metastasis
mesh term: Hyperparathyroidism
mesh term: Hyperparathyroidism, Secondary
sharing ipd: Undecided