Comparison of Total Parathyroidectomy With and Without Autotransplantation

Study Overview
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Brief Summary
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The purpose of this study is to compare short-term and long-term efficacy of total parathyroidectomy with autotransplantation and total parathyroidectomy without autotransplantation for Secondary hyperparathyroidism.

Detailed Description
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Background:Secondary hyperparathyroidism (SHPT) is a common disorder in patients with chronic kidney disease. It is caused by permanent stimulation of the orthotopic and heterotopic parathyroid tissue due to phosphate retention, hypocalcemia, and vitamin D insufficiency. Despite the initiation of new therapeutic agents, several patients will require parathyroidectomy.There are three options for the surgical treatment of SHPT:subtotal PTX (3.5-gland resection,SPTX), total PTX with autotransplantation(TPTX+AT), and total PTX without autotransplantation(TPTX).SPTX and TPTX+AT both leave a fragment of activated,proliferated parathyroid tissue.Since the pathophysiological condition of chronic renal failure and maintenance dialysis continues, the growth stimulus persists and may cause recurrent sHPT.The SPTX procedure has a lesser likelihood of a non-functioning remnant, but recurrent disease always requires a neck reoperation that carries a high likelihood of recurrent laryngeal nerve palsy.Therefore most surgeons believe that TPTX+AT is a better procedure for patients with SHPT. Because of the potential complication of permanent hypocalcemia and adynamic bone disease,TPTX was not introduced into clinical practice.However,recent retrospective studies demonstrated patients after TPTX did not develop permanent hypoparathyroidism and adynamic bone disease as initially expected.Postoperative hypocalcemia is temporary.TPTX may provide an alternative strategy to the currently performed procedures mainly because of the reported lower recurrence rates.An 8-year follow-up study showed the recurrence rates after TPTX is 7%.Recurrence rates after TPTX+AT is 21.4%,and the site of recurrence is located in approximately 80% at the graft and in 20% in the neck.However, to the present there is no randomized controlled trial to Compare the effects of total parathyroidectomy with autotransplantation and total parathyroidectomy without autotransplantation.The purpose of this study is to evaluate the short-term and long-term efficacy of total parathyroidectomy without autotransplantation comparison to total parathyroidectomy with autotransplantation. Intervention: One hundred patients with SHPT need undergo parathyroidectomy at the Second Hospital of Anhui medical university were selected and divided into total parathyroidectomy without autotransplantation group and total parathyroidectomy with autotransplantation group, each group contains 50 cases. Results: Clinical data include: intact parathyroid hormone,serum calcium,serum phosphorus,calcium-phosphorus product,hemoglobin,operation time,morbidity,mortality,clinical symptoms and signs,recurrence and reoperation,quality of life scores. Statistical method: groups t-test, analysis of variance were used.

Official Title
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Comparison of Total Parathyroidectomy With Autotransplantation Versus Total Parathyroidectomy Without Autotransplantation:A Randomized Clinical Trial

Conditions
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Secondary Hyperparathyroidism

Intervention / Treatment
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* Procedure: total PTX without autotransplantation
* Procedure: total PTX with autotransplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both male and female, aged 18 or older; Intact parathyroid hormone(iPTH) is more than 9 times the upper limit of the normal range (about 600pg/ml), with hypercalcemia or hyperphosphatemia; Refractory to medical therapy; Provided written informed consent. Exclusion Criteria: Primary or tertiary hyperparathyroidism; Familial hyperparathyroidism (MENⅠ, MENⅡ, hereditary HPT); Neck surgical exploration history; Parathyroid malignant tumor.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: total PTX without autotransplantation<br>all parathyroid glands were found and removed | Procedure: total PTX without autotransplantation<br>* All parathyroid glands were found and removed and sent for histological confirmation,but without autotransplantation.<br>|
| Active Comparator: total PTX with autotransplantation<br>all parathyroid glands were found and removed,and then a portion of it is sliced into 1*1*1 mm pieces for autotransplantation | Procedure: total PTX with autotransplantation<br>* All parathyroid glands were found and removed and sent for histological confirmation,and then a portion of the smallest, preferably nonnodular parathyroid gland was chosen for autotransplantation,sliced into pieces measuring 1*1 *1 mm,and placed into the subcutaneous of the forearm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of intact parathyroid hormone(iPTH) | Intact parathyroid hormone was collected before operation,1 day,1 week,1 month,3 months,6 months,12 months,18 months and 24months after the operation | 1 day,1 week,1,3,6,12,18 and 24months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of serum calcium | Serum calcium was collected before operation,1 day,1 week,1 month,3 months,6 months,12 months,18 months and 24months after the operation | 1 day,1 week,1,3,6,12,18 and 24months | 
| Change of serum phosphorus | Serum phosphorus was collected before operation,1 day,1 week,1 month,3 months,6 months,12 months,18 months and 24months after the operation | 1 day,1 week,1,3,6,12,18 and 24months | 
| Change of calcium-phosphorus product | Serum calcium*serum phosphorus was collected before operation,1 day,1 week,1 month,3 months,6 months,12 months,18 months and 24months after the operation | 1 day,1 week,1,3,6,12,18 and 24months | 
| Change of hemoglobin | Hemoglobin was collected before operation,1 day,1 week,1 month,3 months,6 months,12 months,18 months and 24months after the operation | 1 day,1 week,1,3,6,12,18 and 24months | 
| Operation time | Operation time is defined as from skin incision to placement of last skin staple | an expected average of 1.5 hours | 
| Morbidity | The severity of complications was graded according to the Clavien-Dindo classification,The most common complication was recurrent laryngeal nerve palsy | 30 days | 
| Mortality | Operative mortality was defined as any death resulting from a complication during surgery | 30 days | 
| Clinical symptoms and signs | Postoperative symptom relief was investigated | From 1 day after the operation, assessed up to 2 years | 
| Recurrence and reoperation | Recurrence and reoperation were recorded | From 1 day after the operation, assessed up to 2 years | 
| Change of quality of life | The Kidney Disease Quality of Life Short Form(KDQOL-SFTM) scale was used to evaluate quality of life before operation, 1 year and 2 years after parathyroidectomy | 1year,2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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secondary hyperparathyroidism, total parathyroidectomy, autotransplantation, morbidity, recurrence, postoperative hypocalcemia