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NCT Number: NCT07575724

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

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.

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Key information

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hangzhou Third People's Hospital, Hangzhou, Zhejiang, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

biopsy tract resection

Procedure

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.

biopsy tract non-resection

Procedure

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.

Primary outcomes

  1. Cumulative incidence of local recurrence at 2 years

    Time frame: 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.

Secondary outcomes

  1. Musculoskeletal Tumor Society score

    Time frame: 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.

  2. Henderson failure mode

    Time frame: 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).

  3. The Patient and Observer Scar Assessment Scale

    Time frame: 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.

  4. Soft tissue reconstruction

    Time frame: perioperative period

    Soft tissue reconstruction will be recorded as whether the patient required additional soft tissue reconstruction procedures (e.g., skin grafting) during surgery.

  5. Total surgical duration

    Time frame: During the operative procedure

    The time elapsed from the first incision to the completion of wound closure, measured in minutes.

  6. Biopsy diagnostic accuracy

    Time frame: 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.

  7. Metastasis free survival (MFS)

    Time frame: 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.

  8. The Toronto Extremity Salvage Score

    Time frame: 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.

  9. Overall survival (OS)

    Time frame: 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.

  10. Need for re-biopsy

    Time frame: preoperative period

    Number of participants requiring more than one biopsy procedure to obtain a definitive diagnostic result.

  11. Request for external pathology consultation

    Time frame: perioperative period

    Number of participants for whom a second opinion from an external pathology department was sought to confirm the primary diagnosis.

  12. intraoperative blood loss

    Time frame: During the surgical procedure

    Total volume of blood lost during the surgical procedure, measured in milliliters (mL).

  13. length of hospital stay

    Time frame: perioperative period

    The total number of days from the date of admission to the date of hospital discharge. This is a continuous outcome

  14. Major wound complications

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Nong Lin, MD

CONTACT

[email protected]

13958195545

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2031
Study completion
2033
First posted
May 8, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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