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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sarcoma; Primary
• Intervention / Treatment: Procedure: biopsy tract resection; Procedure: biopsy tract non-resection

• Study Type: Interventional
• Enrollment (Estimated): 3300
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Nong Lin, MD; Phone Number: 13958195545; Email: linnong@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 311200
      • The Second Affiliated Hospital of Zhejiang University School of Medicine
      • Contact: Keyi Wang, MS; Phone Number: 17398046579; Email: wky82630965@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tract resection group	Procedure: biopsy tract resection; 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.
Active Comparator: tract non-section group	Procedure: biopsy tract non-resection; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative incidence of local recurrence at 2 years	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Musculoskeletal Tumor Society score	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	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	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	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	The time elapsed from the first incision to the completion of wound closure, measured in minutes.	During the operative procedure
Biopsy diagnostic accuracy	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)	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	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)	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	Number of participants requiring more than one biopsy procedure to obtain a definitive diagnostic result.	preoperative period
Request for external pathology consultation	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	Total volume of blood lost during the surgical procedure, measured in milliliters (mL).	During the surgical procedure
length of hospital stay	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	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.

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2033

Study Registration Dates

• First Submitted: April 2, 2026
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Sarcoma
• Other Study ID Numbers: LN_Biopsy_2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No