Comparison of Total Parathyroidectomy With and Without Autotransplantation

Phase 3

• Conditions: Secondary Hyperparathyroidism
• Interventions: Procedure: total PTX without autotransplantation; Procedure: total PTX with autotransplantation

• Registration Number: NCT02536287
• Lead Sponsor: The Second Hospital of Anhui Medical University

Brief Summary

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

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:

1. 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.

2. Statistical method: groups t-test, analysis of variance were used.

Study Timeline

• Status Verified: 2015-08
• Study First Submitted: 2015-08-22
• Study First Submitted QC: 2015-08-26
• Last Update Submitted: 2015-08-26
• Study First Posted: 2015-08-31
• Last Update Posted: 2015-08-31
• Study Start: 2015-09
• Primary Completion: 2016-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
total PTX without autotransplantation	total PTX without autotransplantation	all parathyroid glands were found and removed
total PTX with autotransplantation	total PTX with autotransplantation	all parathyroid glands were found and removed,and then a portion of it is sliced into 1\*1\*1 mm pieces for autotransplantation

Primary Outcome Measures

Name	Time	Method
Change of intact parathyroid hormone(iPTH)	1 day,1 week,1,3,6,12,18 and 24months	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

Secondary Outcome Measures

Name	Time	Method
Change of serum calcium	1 day,1 week,1,3,6,12,18 and 24months	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
Change of serum phosphorus	1 day,1 week,1,3,6,12,18 and 24months	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
Clinical symptoms and signs	From 1 day after the operation, assessed up to 2 years	Postoperative symptom relief was investigated
Change of calcium-phosphorus product	1 day,1 week,1,3,6,12,18 and 24months	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
Change of hemoglobin	1 day,1 week,1,3,6,12,18 and 24months	Hemoglobin was collected before operation,1 day,1 week,1 month,3 months,6 months,12 months,18 months and 24months after the operation
Operation time	an expected average of 1.5 hours	Operation time is defined as from skin incision to placement of last skin staple
Morbidity	30 days	The severity of complications was graded according to the Clavien-Dindo classification,The most common complication was recurrent laryngeal nerve palsy
Mortality	30 days	Operative mortality was defined as any death resulting from a complication during surgery
Recurrence and reoperation	From 1 day after the operation, assessed up to 2 years	Recurrence and reoperation were recorded
Change of quality of life	1year,2 years	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

Trial Locations

Locations (1)

the Second Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China