Subtotal Parathyroidectomy or Total Parathyroidectomy With Autograft in Chronic Kidney Disease Patients Under Dialysis

May 15, 2023 updated by: Sergio Arap, University of Sao Paulo General Hospital

Randomized Clinical Trial of Subtotal Parathyroidectomy or Total Parathyroidectomy With Immediate Heterotopic Autograft in Chronic Renal Disease Patients Stage V Under Dialysis

This study evaluates the metabolic and clinical results of two well recognized and accepted surgical techniques in the management of severe hyperparathyroidism in patients under regular dialysis treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Prospective randomized trial in the surgical management of severe hyperparathyroidism of chronic kidney disease stage V under dialysis. Patients will be randomized and they will be submitted to subtotal parathyroidectomy or total parathyroidectomy with immediate heterotopic autograft of 45 or 90 fragments of parathyroid tissue.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
133

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil
        • University of Sao Paulo General Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Stage V Chronic Kidney Disease patients under regular dialysis treatment with severe hyperparathyroidism requiring parathyroidectomy

Exclusion Criteria:

  • patients refusing to participate in the study (they will receive standard surgery),
  • patients unable to attend regular follow up consultations,
  • patients with a successful kidney transplant at the moment of parathyroidectomy,
  • patients submitted to any previous surgery of the thyroid or parathyroid,
  • patients with chronic kidney disease but not under dialysis

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Subtotal Parathyroidectomy
Patients will be submitted to subtotal parathyroidectomy. The intention is to leave a parathyroid remanent equivalent to two normal parathyroid glands in situ. The type of the operation is the intervention. No drugs or devices are tested.
Procedure: Subtotal Parathyroidectomy
Subtotal parathyroid resection leaving the estimated mass of two normal parathyroid glands in situ. The type of operation is the intervention. No new device or drug is involved.
Active Comparator: Total Parathyroidectomy + 45 autografts
Patients will be submitted to a total parathyroidectomy and 45 fragments of parathyroid tissue are grafted in the forearm. This is the current standard treatment at the institution for severe secondary hyperparathyroidism.The type of operation is the intervention itself. No new device or drug is involved.
Procedure: Total Parathyroidectomy + 45 autografts
Immediate autograft of 45 fragments of parathyroid tissue, after a total parathyroidectomy.This type of operation is the standard intervention at the institution at the moment. No new device or drug is involved.
Experimental: Total Parathyroidectomy + 90 autografts
Patients will be submitted to a total parathyroidectomy and 90 fragments of parathyroid tissue are grafted in the forearm. The type of operation is the intervention. No new device or drug is involved. .
Procedure: Total Parathyroidectomy + 90 autografts
Immediate autograft of 90 fragments of parathyroid tissue, after a total parathyroidectomy.The type of operation is the intervention. No new device or drug is involved.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: From the time of the operation until 5 years after intervention or death if it occurs before 5 years of follow up
Five years survival after parathyroidectomy in an intention to treat analysis
From the time of the operation until 5 years after intervention or death if it occurs before 5 years of follow up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Metabolic Outcome 1: Serum Calcium (mg/dL)
Time Frame: 1 to 60 months after intervention, Samples are taken according to regular follow up
postoperative calcium levels. Below, Above or in the normal range for the method. Analysis will include samples taken close to 1, 3, 6, 12, 24, 36, 48 and 60 months after the operation.
1 to 60 months after intervention, Samples are taken according to regular follow up
Metabolic Outcome 2 : Serum Phosphorus (mg/dL)
Time Frame: 1 to 60 months after intervention, Samples are taken according to regular follow up
postoperative phosphorus levels. Below, above or the normal range for the method employed. Analysis will include samples taken close to 1, 3, 6, 12, 24, 36, 48 and 60 months after the operation.
1 to 60 months after intervention, Samples are taken according to regular follow up
Metabolic Outcome 3: Serum Alkaline Phosphatase (IU)
Time Frame: 1 to 60 months after intervention, Samples are taken according to regular follow up
postoperative alkaline phosphatase levels. Above or in the normal range, according to the method in use. Analysis will include samples taken close to 1, 3, 6, 12, 24, 36, 48 and 60 months after the operation.
1 to 60 months after intervention, Samples are taken according to regular follow up
Metabolic Outcome 4: Serum Parathormone (pg/mL)
Time Frame: 1 to 60 months after intervention, Samples are taken according to regular follow up
postoperative parathormone levels. Below, Above or in the target levels proposed by the National Kidney Foundation, and by the Kidney Disease Improving Global Outcomes (KDIGO). Analysis will include samples taken close to 1, 3, 6, 12, 24, 36, 48 and 60 months after the operation.
1 to 60 months after intervention, Samples are taken according to regular follow up
Drug Requirement 1: Elemental Calcium Intake (g/day)
Time Frame: 1 to 60 months after intervention, according to the dose prescibed in different periods.
The calcium supplement intake (in grams of elemental calcium per day) of the patients after the intervention. Analysis will include first week, then 1, 3, 6, 12, 24,36, 48, 60 months after the intervention.
1 to 60 months after intervention, according to the dose prescibed in different periods.
Drug Requirement 2 Calcitriol intake (micrograms/day)
Time Frame: 1 to 60 months after intervention, according to the dose prescibed in different periods
calcitriol or other vitamin D analogue intake (in micrograms per day) after the intervention. Analysis will include first week, then 1, 3, 6, 12, 24,36, 48, 60 months after the intervention.
1 to 60 months after intervention, according to the dose prescibed in different periods
Drug Requirement 3: Sevelamer (mg/day)
Time Frame: 1 to 60 months after intervention, according to the dose prescibed in different periods
The quantity of phosphorus binding drugs, in special Sevelamer prescribed in milligrams after the intervention. Analysis will include 1, 3, 6, 12, 24,36, 48, 60 months after the operation.
1 to 60 months after intervention, according to the dose prescibed in different periods
Drug Requirement 4: Calcimimetics (mg/day)
Time Frame: 1 to 60 months after intervention, according to the dose prescibed in different periods
The amount of Calcimimetics, in special Cinacalcet im milligrams per day prescribed after the intervention. Analysis will include 1, 3, 6, 12, 24,36, 48, 60 months after the intervention.
1 to 60 months after intervention, according to the dose prescibed in different periods
Clinical Outcome 1: Bone Pain in the VAS
Time Frame: Pre-operative (up to one week before the procedure) until 60 months after intervention
Bone pain measured by the Visual Analogic Pain Scale up to one week before the intervention and up to one week after the procedure, and then at regular follow up. Analysis will concentrate on preoperative (up to one week before), postoperative up to one week, 6,12, 24, 36, 48 and 60 months after the intervention.
Pre-operative (up to one week before the procedure) until 60 months after intervention
Clinical Outcome 2: Postoperative Skeletal Disease (Fractures/Brown tumor)
Time Frame: 1 to 60 months after intervention
skeletal disease is defined as the occurrence of a fracture or the developement brown tumor (osteoclastomas) after the intervention, detected clinically or by any clinically oriented radiography ordered by the attending physician in routine follow up or in any emergency setting.
1 to 60 months after intervention
Clinical Outcome 3: Quality of Life in the SF-36 Questionnaire
Time Frame: Preoperative (up to three days before the intervention) and until 60 months after intervention
quality of life up to one week before the intervention and after the operation at one week, 6 , 12, 24, 36, 48 and 60 months, measured by the Short form 36 questionnaire (SF-36) validated to the cultural and language of the country.
Preoperative (up to three days before the intervention) and until 60 months after intervention
Clinical Outcome 4: Additional Operation (Reoperation in Recurrent/Persistent Disease)
Time Frame: 1 to 60 months after intervention
the necessity of reoperative procedures due to recurrence or persistence of severe hyperparathyroidism, as defined by the attending physician during regular follow up
1 to 60 months after intervention
Morbidity of the surgical procedures
Time Frame: intra-operative to 60 months
After any interventions (initial operation or reoperative interventions necessary in the follow up), it will be actively searched for the occurrence of dysphonia (and its cause according to laryngoscopy), wound infection (clinical signs as red skin, pain, secretion, fever and laboratory evidence), and neck haematoma (large neck blood clots requiring operation)
intra-operative to 60 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sergio S Arap, M.D., University of Sao Paulo General Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CAAE 00828412.8.0000.0068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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