Comparison of Total Parathyroidectomy With Autotransplantation Versus Total Parathyroidectomy Without Autotransplantation:A Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Change of intact parathyroid hormone(iPTH)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Primary or tertiary hyperparathyroidism;
- •Familial hyperparathyroidism (MENⅠ, MENⅡ, hereditary HPT);
- •Neck surgical exploration history;
- •Parathyroid malignant tumor.
结局指标
主要结局
Change of intact parathyroid hormone(iPTH)
时间窗: 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
次要结局
- 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)
- Clinical symptoms and signs(From 1 day after the operation, assessed up to 2 years)
- 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)
- Morbidity(30 days)
- Mortality(30 days)
- Recurrence and reoperation(From 1 day after the operation, assessed up to 2 years)
- Change of quality of life(1year,2 years)
研究者
xpgeng
vice-president
The Second Hospital of Anhui Medical University