Comparison of Total Parathyroidectomy With and Without Autotransplantation
|ClinicalTrials.gov Identifier: NCT02536287|
Recruitment Status : Unknown
Verified August 2015 by xpgeng, The Second Hospital of Anhui Medical University.
Recruitment status was: Not yet recruiting
First Posted : August 31, 2015
Last Update Posted : August 31, 2015
|Condition or disease||Intervention/treatment||Phase|
|Secondary Hyperparathyroidism||Procedure: total PTX without autotransplantation Procedure: total PTX with autotransplantation||Phase 3|
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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Comparison of Total Parathyroidectomy With Autotransplantation Versus Total Parathyroidectomy Without Autotransplantation:A Randomized Clinical Trial|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2018|
Experimental: total PTX without autotransplantation
all parathyroid glands were found and removed
Procedure: total PTX without autotransplantation
All parathyroid glands were found and removed and sent for histological confirmation,but without autotransplantation.
Active Comparator: 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
Procedure: 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.
- Change of intact parathyroid hormone(iPTH) [ Time Frame: 1 day,1 week,1,3,6,12,18 and 24months ]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
- Change of serum calcium [ Time Frame: 1 day,1 week,1,3,6,12,18 and 24months ]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 [ Time Frame: 1 day,1 week,1,3,6,12,18 and 24months ]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 [ Time Frame: 1 day,1 week,1,3,6,12,18 and 24months ]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 [ Time Frame: 1 day,1 week,1,3,6,12,18 and 24months ]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 [ Time Frame: an expected average of 1.5 hours ]Operation time is defined as from skin incision to placement of last skin staple
- Morbidity [ Time Frame: 30 days ]The severity of complications was graded according to the Clavien-Dindo classification,The most common complication was recurrent laryngeal nerve palsy
- Mortality [ Time Frame: 30 days ]Operative mortality was defined as any death resulting from a complication during surgery
- Clinical symptoms and signs [ Time Frame: From 1 day after the operation, assessed up to 2 years ]Postoperative symptom relief was investigated
- Recurrence and reoperation [ Time Frame: From 1 day after the operation, assessed up to 2 years ]Recurrence and reoperation were recorded
- Change of quality of life [ Time Frame: 1year,2 years ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536287
|Contact: xiaoping geng, email@example.com|
|Contact: jin firstname.lastname@example.org|
|Principal Investigator:||xiaoping geng, professor||the vice President of the second affiliated hospitalof Anhui medical university|