Clinical trial NCT02464072: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperparathyroidism, Secondary
Keywords: Parathyroidectomy
Renal Insufficiency, Chronic
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2015-06-08
Enrollment: 133
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Survival
timeFrame: From the time of the operation until 5 years after intervention or death if it occurs before 5 years of follow up
Secondary outcomes:
measure: Metabolic Outcome 1: Serum Calcium (mg/dL)
timeFrame: 1 to 60 months after intervention, Samples are taken according to regular follow up
measure: Metabolic Outcome 2 : Serum Phosphorus (mg/dL)
timeFrame: 1 to 60 months after intervention, Samples are taken according to regular follow up
measure: Metabolic Outcome 3: Serum Alkaline Phosphatase (IU)
timeFrame: 1 to 60 months after intervention, Samples are taken according to regular follow up
measure: Metabolic Outcome 4: Serum Parathormone (pg/mL)
timeFrame: 1 to 60 months after intervention, Samples are taken according to regular follow up
measure: Drug Requirement 1: Elemental Calcium Intake (g/day)
timeFrame: 1 to 60 months after intervention, according to the dose prescibed in different periods.
measure: Drug Requirement 2 Calcitriol intake (micrograms/day)
timeFrame: 1 to 60 months after intervention, according to the dose prescibed in different periods
measure: Drug Requirement 3: Sevelamer (mg/day)
timeFrame: 1 to 60 months after intervention, according to the dose prescibed in different periods
measure: Drug Requirement 4: Calcimimetics (mg/day)
timeFrame: 1 to 60 months after intervention, according to the dose prescibed in different periods
measure: Clinical Outcome 1: Bone Pain in the VAS
timeFrame: Pre-operative (up to one week before the procedure) until 60 months after intervention
measure: Clinical Outcome 2: Postoperative Skeletal Disease (Fractures/Brown tumor)
timeFrame: 1 to 60 months after intervention
measure: Clinical Outcome 3: Quality of Life in the SF-36 Questionnaire
timeFrame: Preoperative (up to three days before the intervention) and until 60 months after intervention
measure: Clinical Outcome 4: Additional Operation (Reoperation in Recurrent/Persistent Disease)
timeFrame: 1 to 60 months after intervention
measure: Morbidity of the surgical procedures
timeFrame: intra-operative to 60 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo General Hospital
state: SP
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Sergio S Arap, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.