Clinical trial NCT02536287: Comparison of Total Parathyroidectomy With and Without Autotransplantation
Official title: Comparison of Total Parathyroidectomy With Autotransplantation Versus Total Parathyroidectomy Without Autotransplantation:A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Secondary Hyperparathyroidism
Keywords: secondary hyperparathyroidism
total parathyroidectomy
autotransplantation
morbidity
recurrence
postoperative hypocalcemia
Lead sponsor: The Second Hospital of Anhui Medical University
Sponsor class: OTHER
First posted: 2015-08-31
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of intact parathyroid hormone(iPTH)
timeFrame: 1 day,1 week,1,3,6,12,18 and 24months
Secondary outcomes:
measure: Change of serum calcium
timeFrame: 1 day,1 week,1,3,6,12,18 and 24months
measure: Change of serum phosphorus
timeFrame: 1 day,1 week,1,3,6,12,18 and 24months
measure: Change of calcium-phosphorus product
timeFrame: 1 day,1 week,1,3,6,12,18 and 24months
measure: Change of hemoglobin
timeFrame: 1 day,1 week,1,3,6,12,18 and 24months
measure: Operation time
timeFrame: an expected average of 1.5 hours
measure: Morbidity
timeFrame: 30 days
measure: Mortality
timeFrame: 30 days
measure: Clinical symptoms and signs
timeFrame: From 1 day after the operation, assessed up to 2 years
measure: Recurrence and reoperation
timeFrame: From 1 day after the operation, assessed up to 2 years
measure: Change of quality of life
timeFrame: 1year,2 years
Other outcomes:
Locations:
city: Hefei
country: China
facility: the Second Affiliated Hospital of Anhui Medical University
state: Anhui
Study officials:
affiliation: the vice President of the second affiliated hospitalof Anhui medical university
name: xiaoping geng, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Puccini M, Carpi A, Cupisti A, Caprioli R, Iacconi P, Barsotti M, Buccianti P, Mechanick J, Nicolini A, Miccoli P. Total parathyroidectomy without autotransplantation for the treatment of secondary hyperparathyroidism associated with chronic kidney disease: clinical and laboratory long-term follow-up. Biomed Pharmacother. 2010 May;64(5):359-62. doi: 10.1016/j.biopha.2009.06.006. Epub 2009 Oct 23.
citation: Jia X, Wang R, Zhang C, Cui M, Xu D. Long-Term Outcomes of Total Parathyroidectomy With or Without Autoimplantation for Hyperparathyroidism in Chronic Kidney Disease: A Meta-Analysis. Ther Apher Dial. 2015 Oct;19(5):477-85. doi: 10.1111/1744-9987.12310. Epub 2015 May 6.
citation: Tominaga Y, Matsuoka S, Sato T. Surgical indications and procedures of parathyroidectomy in patients with chronic kidney disease. Ther Apher Dial. 2005 Feb;9(1):44-7. doi: 10.1111/j.1774-9987.2005.00213.x.
citation: Tominaga Y, Uchida K, Haba T, Katayama A, Sato T, Hibi Y, Numano M, Tanaka Y, Inagaki H, Watanabe I, Hachisuka T, Takagi H. More than 1,000 cases of total parathyroidectomy with forearm autograft for renal hyperparathyroidism. Am J Kidney Dis. 2001 Oct;38(4 Suppl 1):S168-71. doi: 10.1053/ajkd.2001.27432.
citation: Schneider R, Slater EP, Karakas E, Bartsch DK, Schlosser K. Initial parathyroid surgery in 606 patients with renal hyperparathyroidism. World J Surg. 2012 Feb;36(2):318-26. doi: 10.1007/s00268-011-1392-0.