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

実験的：tract resection group

手順：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.

アクティブコンパレータ：tract non-section group

手順：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.

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.

Total surgical duration

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

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.

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.

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.

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.

Need for re-biopsy

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

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.

intraoperative blood loss

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

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

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