Comparison of Total Parathyroidectomy With and Without Autotransplantation
NCT ID: NCT02536287
Last Updated: 2015-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
96 participants
INTERVENTIONAL
2015-09-30
2018-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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total PTX without autotransplantation
all parathyroid glands were found and removed
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 then a portion of it is sliced into 1\*1\*1 mm pieces for 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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Familial hyperparathyroidism (MENⅠ, MENⅡ, hereditary HPT);
* Neck surgical exploration history;
* Parathyroid malignant tumor.
18 Years
ALL
No
Sponsors
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The Second Hospital of Anhui Medical University
OTHER
Responsible Party
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xpgeng
vice-president
Principal Investigators
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xiaoping geng, professor
Role: PRINCIPAL_INVESTIGATOR
the vice President of the second affiliated hospitalof Anhui medical university
Locations
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the Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Countries
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Central Contacts
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Facility Contacts
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Geng Xiaoping
Role: primary
jin ma
Role: backup
References
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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.
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.
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.
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.
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.
Other Identifiers
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Identifier Type: -
Identifier Source: org_study_id