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

Primary Purpose

Hyperparathyroidism, Secondary

Status
Active
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Subtotal Parathyroidectomy
Total Parathyroidectomy + 45 autografts
Total Parathyroidectomy + 90 autografts
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperparathyroidism, Secondary focused on measuring Parathyroidectomy, Renal Insufficiency, Chronic

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Sao Paulo General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Subtotal Parathyroidectomy

Total Parathyroidectomy + 45 autografts

Total Parathyroidectomy + 90 autografts

Arm Description

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.

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.

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. .

Outcomes

Primary Outcome Measures

Survival
Five years survival after parathyroidectomy in an intention to treat analysis

Secondary Outcome Measures

Metabolic Outcome 1: Serum Calcium (mg/dL)
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.
Metabolic Outcome 2 : Serum Phosphorus (mg/dL)
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.
Metabolic Outcome 3: Serum Alkaline Phosphatase (IU)
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.
Metabolic Outcome 4: Serum Parathormone (pg/mL)
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.
Drug Requirement 1: Elemental Calcium Intake (g/day)
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.
Drug Requirement 2 Calcitriol intake (micrograms/day)
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.
Drug Requirement 3: Sevelamer (mg/day)
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.
Drug Requirement 4: Calcimimetics (mg/day)
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.
Clinical Outcome 1: Bone Pain in the VAS
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.
Clinical Outcome 2: Postoperative Skeletal Disease (Fractures/Brown tumor)
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.
Clinical Outcome 3: Quality of Life in the SF-36 Questionnaire
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.
Clinical Outcome 4: Additional Operation (Reoperation in Recurrent/Persistent Disease)
the necessity of reoperative procedures due to recurrence or persistence of severe hyperparathyroidism, as defined by the attending physician during regular follow up
Morbidity of the surgical procedures
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)

Full Information

First Posted
May 18, 2015
Last Updated
May 15, 2023
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02464072
Brief Title
Subtotal Parathyroidectomy or Total Parathyroidectomy With Autograft in Chronic Kidney Disease Patients Under Dialysis
Official Title
Randomized Clinical Trial of Subtotal Parathyroidectomy or Total Parathyroidectomy With Immediate Heterotopic Autograft in Chronic Renal Disease Patients Stage V Under Dialysis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2012 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperparathyroidism, Secondary
Keywords
Parathyroidectomy, Renal Insufficiency, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
133 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subtotal Parathyroidectomy
Arm Type
Experimental
Arm Description
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.
Arm Title
Total Parathyroidectomy + 45 autografts
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Total Parathyroidectomy + 90 autografts
Arm Type
Experimental
Arm Description
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. .
Intervention Type
Procedure
Intervention Name(s)
Subtotal Parathyroidectomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Total Parathyroidectomy + 45 autografts
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Total Parathyroidectomy + 90 autografts
Intervention Description
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.
Primary Outcome Measure Information:
Title
Survival
Description
Five years survival after parathyroidectomy in an intention to treat analysis
Time Frame
From the time of the operation until 5 years after intervention or death if it occurs before 5 years of follow up
Secondary Outcome Measure Information:
Title
Metabolic Outcome 1: Serum Calcium (mg/dL)
Description
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.
Time Frame
1 to 60 months after intervention, Samples are taken according to regular follow up
Title
Metabolic Outcome 2 : Serum Phosphorus (mg/dL)
Description
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.
Time Frame
1 to 60 months after intervention, Samples are taken according to regular follow up
Title
Metabolic Outcome 3: Serum Alkaline Phosphatase (IU)
Description
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.
Time Frame
1 to 60 months after intervention, Samples are taken according to regular follow up
Title
Metabolic Outcome 4: Serum Parathormone (pg/mL)
Description
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.
Time Frame
1 to 60 months after intervention, Samples are taken according to regular follow up
Title
Drug Requirement 1: Elemental Calcium Intake (g/day)
Description
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.
Time Frame
1 to 60 months after intervention, according to the dose prescibed in different periods.
Title
Drug Requirement 2 Calcitriol intake (micrograms/day)
Description
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.
Time Frame
1 to 60 months after intervention, according to the dose prescibed in different periods
Title
Drug Requirement 3: Sevelamer (mg/day)
Description
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.
Time Frame
1 to 60 months after intervention, according to the dose prescibed in different periods
Title
Drug Requirement 4: Calcimimetics (mg/day)
Description
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.
Time Frame
1 to 60 months after intervention, according to the dose prescibed in different periods
Title
Clinical Outcome 1: Bone Pain in the VAS
Description
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.
Time Frame
Pre-operative (up to one week before the procedure) until 60 months after intervention
Title
Clinical Outcome 2: Postoperative Skeletal Disease (Fractures/Brown tumor)
Description
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.
Time Frame
1 to 60 months after intervention
Title
Clinical Outcome 3: Quality of Life in the SF-36 Questionnaire
Description
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.
Time Frame
Preoperative (up to three days before the intervention) and until 60 months after intervention
Title
Clinical Outcome 4: Additional Operation (Reoperation in Recurrent/Persistent Disease)
Description
the necessity of reoperative procedures due to recurrence or persistence of severe hyperparathyroidism, as defined by the attending physician during regular follow up
Time Frame
1 to 60 months after intervention
Title
Morbidity of the surgical procedures
Description
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)
Time Frame
intra-operative to 60 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergio S Arap, M.D.
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo General Hospital
City
Sao Paulo
State/Province
SP
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30082137
Citation
Filho WA, van der Plas WY, Brescia MDG, Nascimento CP Jr, Goldenstein PT, Neto LMM, Arap SS, Custodio MR, Bueno RO, Moyses RMA, Jorgetti V, Kruijf S, Montenegro FLM. Quality of life after surgery in secondary hyperparathyroidism, comparing subtotal parathyroidectomy with total parathyroidectomy with immediate parathyroid autograft: Prospective randomized trial. Surgery. 2018 Nov;164(5):978-985. doi: 10.1016/j.surg.2018.06.032. Epub 2018 Aug 3. Erratum In: Surgery. 2019 Feb;165(2):497.
Results Reference
background
PubMed Identifier
29146232
Citation
Albuquerque RFC, Carbonara CEM, Martin RCT, Dos Reis LM, do Nascimento CP Junior, Arap SS, Moyses RMA, Jorgetti V, Montenegro FLM, de Oliveira RB. Parathyroidectomy in patients with chronic kidney disease: Impacts of different techniques on the biochemical and clinical evolution of secondary hyperparathyroidism. Surgery. 2018 Feb;163(2):381-387. doi: 10.1016/j.surg.2017.09.005. Epub 2017 Nov 13.
Results Reference
background
PubMed Identifier
32811697
Citation
Silveira AA, Brescia MDG, do Nascimento CP Jr, Arap SS, Montenegro FLM. Critical analysis of the intraoperative parathyroid hormone decrease during parathyroidectomy for secondary and tertiary hyperparathyroidism. Surgery. 2020 Dec;168(6):1079-1085. doi: 10.1016/j.surg.2020.06.043. Epub 2020 Aug 15.
Results Reference
background
PubMed Identifier
33475675
Citation
Silveira AA, Brescia MDG, Nascimento CPD Jr, Arap SS, Montenegro FLM. Delayed sampling of intraoperative parathormone may be unnecessary during parathyroidectomy in kidney-transplanted and dialysis patients. J Bras Nefrol. 2021 Apr-Jun;43(2):228-235. doi: 10.1590/2175-8239-JBN-2020-0108.
Results Reference
derived

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

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