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

NCT02464072 | Unknown

• 1 other identifier: CAAE 00828412.8.0000.0068
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperparathyroidism, Secondary

Keywords

Parathyroidectomy; Renal Insufficiency, Chronic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Metabolic Outcome 1: Serum Calcium (mg/dL)

  1 to 60 months after intervention, Samples are taken according to regular follow up

• Metabolic Outcome 2 : Serum Phosphorus (mg/dL)

  1 to 60 months after intervention, Samples are taken according to regular follow up

• Metabolic Outcome 3: Serum Alkaline Phosphatase (IU)

  1 to 60 months after intervention, Samples are taken according to regular follow up

• Metabolic Outcome 4: Serum Parathormone (pg/mL)

  1 to 60 months after intervention, Samples are taken according to regular follow up

• Drug Requirement 1: Elemental Calcium Intake (g/day)

  1 to 60 months after intervention, according to the dose prescibed in different periods.

Study Arms (3)

Subtotal Parathyroidectomy

EXPERIMENTAL

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

Total Parathyroidectomy + 45 autografts

ACTIVE COMPARATOR

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

Total Parathyroidectomy + 90 autografts

EXPERIMENTAL

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

Interventions

Subtotal Parathyroidectomy PROCEDURE

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.

Subtotal Parathyroidectomy

Total Parathyroidectomy + 45 autografts PROCEDURE

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 + 45 autografts

Total Parathyroidectomy + 90 autografts PROCEDURE

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.

Total Parathyroidectomy + 90 autografts

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

University of Sao Paulo General Hospital

São Paulo, São Paulo, Brazil

Location

Related Publications (5)

• 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.

  PMID: 30082137 BACKGROUND

• 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.

  PMID: 29146232 BACKGROUND

• 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.

  PMID: 32811697 BACKGROUND

• Pereira GMD, Liao M, Arap SS, Magnabosco FF, Brescia MDG, Moyses RMA, Custodio MR, Jorgetti V, Kowalski LP, Montenegro FLM. Parathyroidectomy reduces the costs of medication in patients with secondary hyperparathyroidism. Clinics (Sao Paulo). 2024 Sep 15;79:100484. doi: 10.1016/j.clinsp.2024.100484. eCollection 2024.

  PMID: 39284277 DERIVED

• 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.

  PMID: 33475675 DERIVED

MeSH Terms

Conditions

Hyperparathyroidism, Secondary; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sergio S Arap, M.D.

  University of Sao Paulo General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physcian

Study Record Dates

• First Submitted: May 18, 2015
• First Posted: June 8, 2015
• Study Start: July 1, 2012
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: May 17, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)