Comparison of Total Parathyroidectomy With and Without Autotransplantation

Secondary Hyperparathyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02536287
• Other study ID #: ahykdxdefsyy12
• Status: Not yet recruiting
• Phase: Phase 3
• First received: August 22, 2015
• Last updated: August 26, 2015
• Start date: September 2015
• Est. completion date: December 2018

Study information

• Verified date: August 2015
• Source: The Second Hospital of Anhui Medical University
• Contact: xiaoping geng, professor
• Phone: 86+13956010132
• Email: xp_geng[@]163.net
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: December 2018
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 (MEN?, MEN?, hereditary HPT);

• Neck surgical exploration history;

• Parathyroid malignant tumor.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Secondary Hyperparathyroidism

Intervention

Procedure:
• total PTX without autotransplantation
All parathyroid glands were found and removed and sent for histological confirmation,but without autotransplantation.
• total PTX with autotransplantation
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.

Locations

Country	Name	City	State
China	the Second Affiliated Hospital of Anhui Medical University	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Anhui Medical University

Country where clinical trial is conducted

China, 

References & Publications (5)

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. E — View 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 diseas — View 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. — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Operation time	Operation time is defined as from skin incision to placement of last skin staple	an expected average of 1.5 hours	Yes
Secondary	Morbidity	The severity of complications was graded according to the Clavien-Dindo classification,The most common complication was recurrent laryngeal nerve palsy	30 days	Yes
Secondary	Mortality	Operative mortality was defined as any death resulting from a complication during surgery	30 days	Yes
Secondary	Clinical symptoms and signs	Postoperative symptom relief was investigated	From 1 day after the operation, assessed up to 2 years	Yes
Secondary	Recurrence and reoperation	Recurrence and reoperation were recorded	From 1 day after the operation, assessed up to 2 years	Yes
Secondary	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	Yes