Comparison of Total Parathyroidectomy With and Without Autotransplantation
Primary Purpose
Secondary Hyperparathyroidism
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
total PTX without autotransplantation
total PTX with autotransplantation
Sponsored by
About this trial
This is an interventional treatment trial for Secondary Hyperparathyroidism focused on measuring secondary hyperparathyroidism, total parathyroidectomy, autotransplantation, morbidity, recurrence, postoperative hypocalcemia
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.
Sites / Locations
- the Second Affiliated Hospital of Anhui Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
total PTX without autotransplantation
total PTX with autotransplantation
Arm Description
all parathyroid glands were found and removed
all parathyroid glands were found and removed,and then a portion of it is sliced into 1*1*1 mm pieces for autotransplantation
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
Operation time
Operation time is defined as from skin incision to placement of last skin staple
Morbidity
The severity of complications was graded according to the Clavien-Dindo classification,The most common complication was recurrent laryngeal nerve palsy
Mortality
Operative mortality was defined as any death resulting from a complication during surgery
Clinical symptoms and signs
Postoperative symptom relief was investigated
Recurrence and reoperation
Recurrence and reoperation were recorded
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
Full Information
NCT ID
NCT02536287
First Posted
August 22, 2015
Last Updated
August 26, 2015
Sponsor
The Second Hospital of Anhui Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02536287
Brief Title
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
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Second Hospital of Anhui Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
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.
Statistical method: groups t-test, analysis of variance were used.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism
Keywords
secondary hyperparathyroidism, total parathyroidectomy, autotransplantation, morbidity, recurrence, postoperative hypocalcemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
total PTX without autotransplantation
Arm Type
Experimental
Arm Description
all parathyroid glands were found and removed
Arm Title
total PTX with autotransplantation
Arm Type
Active Comparator
Arm Description
all parathyroid glands were found and removed,and then a portion of it is sliced into 1*1*1 mm pieces for autotransplantation
Intervention Type
Procedure
Intervention Name(s)
total PTX without autotransplantation
Intervention Description
All parathyroid glands were found and removed and sent for histological confirmation,but without autotransplantation.
Intervention Type
Procedure
Intervention Name(s)
total PTX with autotransplantation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of intact parathyroid hormone(iPTH)
Description
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
Time Frame
1 day,1 week,1,3,6,12,18 and 24months
Secondary Outcome Measure Information:
Title
Change of serum calcium
Description
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
Time Frame
1 day,1 week,1,3,6,12,18 and 24months
Title
Change of serum phosphorus
Description
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
Time Frame
1 day,1 week,1,3,6,12,18 and 24months
Title
Change of calcium-phosphorus product
Description
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
Time Frame
1 day,1 week,1,3,6,12,18 and 24months
Title
Change of hemoglobin
Description
Hemoglobin was collected before operation,1 day,1 week,1 month,3 months,6 months,12 months,18 months and 24months after the operation
Time Frame
1 day,1 week,1,3,6,12,18 and 24months
Title
Operation time
Description
Operation time is defined as from skin incision to placement of last skin staple
Time Frame
an expected average of 1.5 hours
Title
Morbidity
Description
The severity of complications was graded according to the Clavien-Dindo classification,The most common complication was recurrent laryngeal nerve palsy
Time Frame
30 days
Title
Mortality
Description
Operative mortality was defined as any death resulting from a complication during surgery
Time Frame
30 days
Title
Clinical symptoms and signs
Description
Postoperative symptom relief was investigated
Time Frame
From 1 day after the operation, assessed up to 2 years
Title
Recurrence and reoperation
Description
Recurrence and reoperation were recorded
Time Frame
From 1 day after the operation, assessed up to 2 years
Title
Change of quality of life
Description
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
Time Frame
1year,2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xiaoping geng, professor
Phone
86+13956010132
Email
xp_geng@163.net
First Name & Middle Initial & Last Name or Official Title & Degree
jin ma
Phone
86+15056069536
Email
aydmajin@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xiaoping geng, professor
Organizational Affiliation
the vice President of the second affiliated hospitalof Anhui medical university
Official's Role
Principal Investigator
Facility Information:
Facility Name
the Second Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geng Xiaoping
Phone
86+13956010132
Email
xp_geng@163.net
First Name & Middle Initial & Last Name & Degree
jin ma
Phone
86+15056069536
Email
aydmajin@163.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
20435429
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.
Results Reference
result
PubMed Identifier
25950238
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.
Results Reference
result
PubMed Identifier
15828905
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.
Results Reference
result
PubMed Identifier
11576947
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.
Results Reference
result
PubMed Identifier
22202993
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.
Results Reference
result
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Comparison of Total Parathyroidectomy With and Without Autotransplantation
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