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.
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 2
Контакты и местонахождение
Контакты исследования
- Имя: Nong Lin, MD
- Номер телефона: 13958195545
- Электронная почта: linnong@zju.edu.cn
Места учебы
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Zhejiang
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Hangzhou, Zhejiang, Китай
- Hangzhou Third People's Hospital
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Контакт:
- Yefeng Xu
- Номер телефона: 15068710437
- Электронная почта: 2173799040@qq.com
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Hangzhou, Zhejiang, Китай, 311200
- The Second Affiliated Hospital of Zhejiang University School of Medicine
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Контакт:
- Keyi Wang, MS
- Номер телефона: 17398046579
- Электронная почта: wky82630965@gmail.com
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: tract resection group
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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. |
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Активный компаратор: tract non-section group
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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. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Cumulative incidence of local recurrence at 2 years
Временное ограничение: 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.
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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.
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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.
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Musculoskeletal Tumor Society score
Временное ограничение: recorded at baseline and at 3, 6, 9, 12, 15, 18, 21, and 24 months after surgery.
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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.
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recorded at baseline and at 3, 6, 9, 12, 15, 18, 21, and 24 months after surgery.
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Henderson failure mode
Временное ограничение: From surgery to 24 months, assessed every 3 months
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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).
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From surgery to 24 months, assessed every 3 months
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The Patient and Observer Scar Assessment Scale
Временное ограничение: From surgery to 24 months, assessed every 3 months
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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.
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From surgery to 24 months, assessed every 3 months
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Soft tissue reconstruction
Временное ограничение: perioperative period
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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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perioperative period
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Total surgical duration
Временное ограничение: During the operative procedure
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The time elapsed from the first incision to the completion of wound closure, measured in minutes.
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During the operative procedure
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Biopsy diagnostic accuracy
Временное ограничение: perioperative period
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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.
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perioperative period
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Metastasis free survival (MFS)
Временное ограничение: From surgery to 24 months, assessed every 6 months
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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.
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From surgery to 24 months, assessed every 6 months
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The Toronto Extremity Salvage Score
Временное ограничение: From surgery to 24 months, assessed every 3 months
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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.
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From surgery to 24 months, assessed every 3 months
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Overall survival (OS)
Временное ограничение: From surgery to 24 months, assessed every 3 months
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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.
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From surgery to 24 months, assessed every 3 months
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Need for re-biopsy
Временное ограничение: preoperative period
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Number of participants requiring more than one biopsy procedure to obtain a definitive diagnostic result.
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preoperative period
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Request for external pathology consultation
Временное ограничение: perioperative period
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Number of participants for whom a second opinion from an external pathology department was sought to confirm the primary diagnosis.
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perioperative period
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intraoperative blood loss
Временное ограничение: During the surgical procedure
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Total volume of blood lost during the surgical procedure, measured in milliliters (mL).
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During the surgical procedure
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length of hospital stay
Временное ограничение: perioperative period
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The total number of days from the date of admission to the date of hospital discharge.
This is a continuous outcome
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perioperative period
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Major wound complications
Временное ограничение: Assessed from the date of surgery to 120 days after surgery.
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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.
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Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- LN_Biopsy_2025
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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