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

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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 Intratumo
• Процедура 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

Первичные конечные точки

• Cumulative incidence of local recurrence at 2 years [Срок оценки: 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.]

Вторичные конечные точки (12)

• Musculoskeletal Tumor Society score [Срок оценки: recorded at baseline and at 3, 6, 9, 12, 15, 18, 21, and 24 months after surgery.]
• Henderson failure mode [Срок оценки: From surgery to 24 months, assessed every 3 months]
• The Patient and Observer Scar Assessment Scale [Срок оценки: From surgery to 24 months, assessed every 3 months]
• Soft tissue reconstruction [Срок оценки: perioperative period]
• Total surgical duration [Срок оценки: During the operative procedure]
• Biopsy diagnostic accuracy [Срок оценки: perioperative period]
• Metastasis free survival (MFS) [Срок оценки: From surgery to 24 months, assessed every 6 months]
• The Toronto Extremity Salvage Score [Срок оценки: From surgery to 24 months, assessed every 3 months]
• Overall survival (OS) [Срок оценки: From surgery to 24 months, assessed every 3 months]
• Need for re-biopsy [Срок оценки: preoperative period]
• Request for external pathology consultation [Срок оценки: perioperative period]
• intraoperative blood loss [Срок оценки: During the surgical procedure]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• the Second Affiliated Hospital of Zhejiang University School of Medicine — Ханчжоу
• Hangzhou Third People's Hospital — Ханчжоу

Идентификаторы

NCT: NCT07575724 · LN_Biopsy_2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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