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

Hyperparathyroidism, Secondary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02464072
• Other study ID #: CAAE 00828412.8.0000.0068
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2012
• Est. completion date: January 2024

Study information

• Verified date: May 2023
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 133
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Brazil	University of Sao Paulo General Hospital	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	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	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.	1 to 60 months after intervention, Samples are taken according to regular follow up
Secondary	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.	1 to 60 months after intervention, Samples are taken according to regular follow up
Secondary	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.	1 to 60 months after intervention, Samples are taken according to regular follow up
Secondary	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.	1 to 60 months after intervention, Samples are taken according to regular follow up
Secondary	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.	1 to 60 months after intervention, according to the dose prescibed in different periods.
Secondary	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.	1 to 60 months after intervention, according to the dose prescibed in different periods
Secondary	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.	1 to 60 months after intervention, according to the dose prescibed in different periods
Secondary	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.	1 to 60 months after intervention, according to the dose prescibed in different periods
Secondary	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.	Pre-operative (up to one week before the procedure) until 60 months after intervention
Secondary	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.	1 to 60 months after intervention
Secondary	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.	Preoperative (up to three days before the intervention) and until 60 months after intervention
Secondary	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	1 to 60 months after intervention
Secondary	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)	intra-operative to 60 months