Comparison of Total Parathyroidectomy With and Without Autotransplantation
1 other identifier
interventional
96
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2015
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2015
CompletedFirst Posted
Study publicly available on registry
August 31, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedAugust 31, 2015
August 1, 2015
1.3 years
August 22, 2015
August 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
Change of serum calcium
1 day,1 week,1,3,6,12,18 and 24months
Change of serum phosphorus
1 day,1 week,1,3,6,12,18 and 24months
Change of calcium-phosphorus product
1 day,1 week,1,3,6,12,18 and 24months
Change of hemoglobin
1 day,1 week,1,3,6,12,18 and 24months
Operation time
an expected average of 1.5 hours
- +5 more secondary outcomes
Study Arms (2)
total PTX without autotransplantation
EXPERIMENTALall parathyroid glands were found and removed
total PTX with autotransplantation
ACTIVE COMPARATORall parathyroid glands were found and removed,and then a portion of it is sliced into 1\*1\*1 mm pieces for autotransplantation
Interventions
All parathyroid glands were found and removed and sent for histological confirmation,but without 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
You may qualify if:
- 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.
You may not qualify if:
- Primary or tertiary hyperparathyroidism;
- Familial hyperparathyroidism (MENⅠ, MENⅡ, hereditary HPT);
- Neck surgical exploration history;
- Parathyroid malignant tumor.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
the Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022, China
Related Publications (5)
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.
PMID: 20435429RESULTJia 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.
PMID: 25950238RESULTTominaga 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.
PMID: 15828905RESULTTominaga 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.
PMID: 11576947RESULTSchneider 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.
PMID: 22202993RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
xiaoping geng, professor
the vice President of the second affiliated hospitalof Anhui medical university
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- vice-president
Study Record Dates
First Submitted
August 22, 2015
First Posted
August 31, 2015
Study Start
September 1, 2015
Primary Completion
December 1, 2016
Study Completion
December 1, 2018
Last Updated
August 31, 2015
Record last verified: 2015-08