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.
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;
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;
Parallel
biopsy tract resection
Procedure/SurgerySurgeons 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/SurgerySurgeons 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.
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.
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.
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).
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.
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.
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