Comparison of the Effects of Needle Biopsy Tract Resection and Non-resection on Recurrence Rate in Patients With Primary Extremity Sarcoma: Study Protocol of a Randomized, Non-inferior Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3,300
- 试验地点
- 2
研究概览
简要总结
This randomized, non-inferiority clinical trial aims to evaluate whether non-resection of needle biopsy tract is non-inferior to routine biopsy tract resection in terms of local recurrence in patients with primary extremity musculoskeletal sarcoma undergoing en-bloc surgical treatment.
Biopsy tract resection is traditionally recommended to reduce the risk of tumor seeding; however, its benefit in reducing recurrence has not been definitively demonstrated, particularly when core needle biopsy is widely used. Also, avoiding biopsy tract resection may preserve uninvolved tissue without compromising oncologic safety.
The primary objective of this study is to compare local recurrence rates between patients who undergo biopsy tract resection and those who do not. Secondary objectives include comparisons of surgical complications, functional outcomes, overall survival, and progression-free survival.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of primary bone or soft tissue sarcoma of the extremities (or highly suspected sarcoma);
- •Candidate for limb-sparing surgery and capable of en-bloc resection;
- •Age ≥ 5 years;
- •ECOG performance status 0-2;
- •Able to understand and sign informed consent.
排除标准
- •Presence of distant metastasis (e.g., lung, bone, or other sites) or unresectable skip lesions;
- •Patients deemed, based on preoperative multidisciplinary team (MDT) evaluation, unlikely to achieve adequate surgical margins and therefore only eligible for debulking or palliative surgery;
- •Patients with inconclusive needle biopsy results requiring open biopsy for definitive diagnosis;
- •Patients requiring amputation;
- •Patients who have received prior treatment for the tumor at non-participating centers;
- •Patients with an expected survival of less than 2 years;
- •Patients in whom the biopsy tract completely lies within the planned tumor resection field;
- •Patients who refuse to provide written informed consent.
研究组 & 干预措施
tract resection group
干预措施: biopsy tract resection (Procedure)
tract non-section group
干预措施: biopsy tract non-resection (Procedure)