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Comparison of the Effects of Needle Biopsy Tract Resection and Non-resection on Recurrence Rate in Patients With Primary Extremity Sarcoma

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

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.

研究概览

研究类型

介入性

注册 (估计的)

3300

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Zhejiang
      • Hangzhou、Zhejiang、中国
        • Hangzhou Third People's Hospital
        • 接触:
      • Hangzhou、Zhejiang、中国、311200
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Histologically confirmed diagnosis of primary bone or soft tissue sarcoma of the extremities (or highly suspected sarcoma);
  2. Candidate for limb-sparing surgery and capable of en-bloc resection;
  3. Age ≥ 5 years;
  4. ECOG performance status 0-2;
  5. Able to understand and sign informed consent.

Exclusion Criteria:

  1. Presence of distant metastasis (e.g., lung, bone, or other sites) or unresectable skip lesions;
  2. Patients deemed, based on preoperative multidisciplinary team (MDT) evaluation, unlikely to achieve adequate surgical margins and therefore only eligible for debulking or palliative surgery;
  3. Patients with inconclusive needle biopsy results requiring open biopsy for definitive diagnosis;
  4. Patients requiring amputation;
  5. Patients who have received prior treatment for the tumor at non-participating centers;
  6. Patients with an expected survival of less than 2 years;
  7. Patients in whom the biopsy tract completely lies within the planned tumor resection field;
  8. Patients who refuse to provide written informed consent.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:tract resection group

Surgeons will perform standard en-bloc tumor resection according to oncologic principles. In the biopsy tract resection group, complete biopsy tract excision is defined as en-bloc removal of the entire needle biopsy pathway, including:

Skin entry site: the original puncture site on the skin surface Subcutaneous and soft tissue tract: all intervening tissues traversed by the biopsy needle Deep tract structures: any muscle, fascia, periosteum, or bone structures penetrated by the needle Intratumoral component: the terminal segment of the needle pathway within the tumor

All components of the biopsy tract must be removed together with the tumor specimen.

有源比较器:tract non-section group

Surgeons will perform standard en bloc tumor resection in accordance with oncologic principles. In the non-resection group, the needle biopsy tract will not be intentionally excised. The biopsy tract, including the skin entry site and intervening soft tissue pathway, will be preserved unless it lies within the planned tumor resection field.

If any portion of the biopsy tract is located within the standard oncologic resection field required to achieve negative margins, it will be removed as part of the tumor specimen; however, no additional resection will be performed specifically to excise the biopsy tract.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Cumulative incidence of local recurrence at 2 years
大体时间:From the date of surgery to the date of first documented local recurrence, death, or last follow-up, assessed up to 24 months after surgery.
Local recurrence is defined as radiologically or pathologically confirmed recurrence of sarcoma at or adjacent to the primary surgical site after definitive tumor resection. The cumulative incidence of local recurrence will be estimated with death treated as a competing event.
From the date of surgery to the date of first documented local recurrence, death, or last follow-up, assessed up to 24 months after surgery.

次要结果测量

结果测量
措施说明
大体时间
Musculoskeletal Tumor Society score
大体时间:recorded at baseline and at 3, 6, 9, 12, 15, 18, 21, and 24 months after surgery.
MSTS assesses 6 aspects of a patient's quality including pain, function, emotional, supports, walking and gait with regard to their treatment. higher score. The score ranges from 0% (worst function) to 100% (best function). It is a repeated continuous outcome.
recorded at baseline and at 3, 6, 9, 12, 15, 18, 21, and 24 months after surgery.
Henderson failure mode
大体时间:From surgery to 24 months, assessed every 3 months
Henderson failure mode defined as : soft-tissue failure (Type 1), aseptic loosening (Type 2), structural failure (Type 3), infection (Type 4), and tumor progression (Type 5).
From surgery to 24 months, assessed every 3 months
The Patient and Observer Scar Assessment Scale
大体时间:From surgery to 24 months, assessed every 3 months
The Patient and Observer Scar Assessment Scale (POSAS) questionnare is used to evaluate scar quality from both the patient's and the observer's perspectives. Each scale consists of six items, with each item scored from 1 (normal skin) to 10 (worst imaginable scar). Total scores range from 6 to 60, with lower scores indicating better quality.
From surgery to 24 months, assessed every 3 months
Soft tissue reconstruction
大体时间:perioperative period
Soft tissue reconstruction will be recorded as whether the patient required additional soft tissue reconstruction procedures (e.g., skin grafting) during surgery.
perioperative period
Total surgical duration
大体时间:During the operative procedure
The time elapsed from the first incision to the completion of wound closure, measured in minutes.
During the operative procedure
Biopsy diagnostic accuracy
大体时间:perioperative period
Diagnostic accuracy was defined as the percentage of participants whose percutaneous biopsy results are concordant with the final histopathological diagnosis from the surgical specimen. This is a binary outcome.
perioperative period
Metastasis free survival (MFS)
大体时间:From surgery to 24 months, assessed every 6 months
Metastasis-free survival is defined as the time from definitive surgery to the first radiologically confirmed distant metastasis (e.g., lung, bone, or other organs). Metastasis will be assessed using scheduled chest CT scans and other imaging as clinically indicated. Participants without metastasis will be censored at their last follow-up visit.
From surgery to 24 months, assessed every 6 months
The Toronto Extremity Salvage Score
大体时间:From surgery to 24 months, assessed every 3 months
The Toronto Extremity Salvage Score (TESS) is a patient-reported outcome measure (PROM) specifically designed to evaluate the physical function of individuals who have undergone limb-salvage surgery for bone or soft-tissue sarcomas.The raw score is converted into a percentage ranging from 0 to 100. Higher score indicates better function.
From surgery to 24 months, assessed every 3 months
Overall survival (OS)
大体时间:From surgery to 24 months, assessed every 3 months
Overall survival is defined as the time from definitive surgery to death from any cause. Participants alive at last follow-up will be censored. Survival status will be assessed at each scheduled visit.
From surgery to 24 months, assessed every 3 months
Need for re-biopsy
大体时间:preoperative period
Number of participants requiring more than one biopsy procedure to obtain a definitive diagnostic result.
preoperative period
Request for external pathology consultation
大体时间:perioperative period
Number of participants for whom a second opinion from an external pathology department was sought to confirm the primary diagnosis.
perioperative period
intraoperative blood loss
大体时间:During the surgical procedure
Total volume of blood lost during the surgical procedure, measured in milliliters (mL).
During the surgical procedure
length of hospital stay
大体时间:perioperative period
The total number of days from the date of admission to the date of hospital discharge. This is a continuous outcome
perioperative period
Major wound complications
大体时间:Assessed from the date of surgery to 120 days after surgery.

Major wound complication was defined according to the O' sullivian et al (the Lancet, 2002). They are defined as a secondary operation under general or regional anaesthesia for wound repair (debridement, operative drainage, and secondary wound closure including rotationplasty, free flaps, or skin grafts),or wound management without secondary operation.

Wound management included an invasive procedure without general or regional anaesthesia (mainly aspiration of seroma), readmission for wound care such as intravenous antibiotics, or persistent deep packing for 120 days or longer. It will be recorded as binary outcome

Assessed from the date of surgery to 120 days after surgery.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年12月1日

初级完成 (估计的)

2031年12月1日

研究完成 (估计的)

2033年12月1日

研究注册日期

首次提交

2026年4月2日

首先提交符合 QC 标准的

2026年5月4日

首次发布 (实际的)

2026年5月8日

研究记录更新

最后更新发布 (实际的)

2026年7月14日

上次提交的符合 QC 标准的更新

2026年7月12日

最后验证

2025年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • LN_Biopsy_2025

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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