The Percutaneous Interventional Surgery Control System for Pulmonary Nodule Biopsy

Официальное название

A Prospective, Single-center, Randomized Controlled Clinical Study to Evaluate the Efficacy and Safety of the Percutaneous Interventional Surgery Control System for Pulmonary Nodule Biopsy

Обзор

This prospective, single-center, non-inferiority, randomized controlled clinical trial aims to evaluate the efficacy and safety of a percutaneous interventional surgical control system in performing percutaneous needle biopsy of pulmonary nodules, compared with conventional manual biopsy. The study will be conducted at Shanghai Chest Hospital and plans to enroll 158 patients who meet the indications for percutaneous transthoracic needle biopsy (PTNB) and have no contraindications. Participants will be randomly assigned to one of two groups: the experimental group will undergo PTNB assisted by the percutaneous interventional surgical control system, while the control group will receive traditional manual PTNB. The primary endpoint is diagnostic yield; secondary endpoints include technical success rate, number of needle adjustments, puncture time, total procedure time, radiation dose, and complication rates.

Вмешательства

• Диагностический тест Percutaneous Needle Biopsy with Interventional Surgical Control System
  Patients undergo percutaneous needle biopsy of pulmonary nodules with assistance from a percutaneous interventional surgical control system. The system performs automatically needle positioning and puncture.
• Диагностический тест Conventional Manual Percutaneous Needle Biopsy
  Patients receive traditional manual percutaneous needle biopsy of pulmonary nodules under CT guidance, operated by experienced interventional physicians.

Первичные конечные точки

• Dianostic yield [Срок оценки: Up to 6 months after biopsy]

Вторичные конечные точки (6)

• Technical Success Rate [Срок оценки: Intra-operative]
• Number of Needle Adjustments [Срок оценки: Intra-operative]
• Puncture time [Срок оценки: Intra-operative]
• Procedural Time [Срок оценки: Intra-operative]
• Complication rate [Срок оценки: Up to 6 months after biopsy]
• Radiation dose [Срок оценки: Intra-operative]

Критерии участия

Критерии включения

1\) Age ranging from 18 years old to 80 years old, gender not restricted; 2) Patients with pulmonary nodules detected by chest CT, suspected to be malignant and judged by the researchers to require puncture biopsy for a clear diagnosis; 3) Pulmonary nodules with a long diameter greater than 8mm but not exceeding 30mm; 4) Have signed the informed consent form and voluntarily participate in this clinical study; 5) Can understand this research and cooperate with the research procedures, and can follow the requirements for follow-up observation.

Критерии исключения

1\) Subjects with irreparable coagulation dysfunction, infectious lesions on the puncture path, lesions adjacent to organs or surrounded by large blood vessels, suspected pulmonary echinococcosis on imaging, patients on mechanical ventilation (with a ventilator), liver multilocular echinococcosis, coma or other patients who are uncooperative; 2) Those judged by the investigators to be unsuitable for chest percutaneous puncture surgery: such as severe pulmonary hypertension, pulmonary bullae, chronic obstructive pulmonary disease, emphysema, pulmonary fibrosis; 3) Poor overall condition (multiple systemic metastases, severe infection, high fever), obvious cachexia, severe dysfunction of important organs, severe anemia and nutritional metabolic disorders that cannot be improved in the short term; 4) Those allergic to contrast agents or anesthetics; 5) Implantation of pacemakers; 6) Pregnant or lactating women, or those with a fertility plan during the clinical trial; 7) Patients who cannot cooperate with the doctor to complete the puncture surgery, such as known drug or alcohol addiction, mental and neurological diseases, intellectual disability, psychological disorders, etc.; 8) Those participating in another drug or medical device clinical trial (within 3 months of drug clinical trial or within 1 month of medical device clinical trial); 9) The target lesion has been diagnosed or has received treatment; 10) Other situations that the investigator deems not suitable for this clinical trial.

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

Простое слепое

Основная цель

Диагностика

Центры проведения

Китай · 1 центр

• Shanghai Chest Hospital — Шанхай

Публикации

• Anzidei M, Argiro R, Porfiri A, Boni F, Anile M, Zaccagna F, Vitolo D, Saba L, Napoli A, Leonardi A, Longo F, Venuta F, Bezzi M, Catalano C. Preliminary clinical experience with a dedicated interventional robotic system for CT-guided biopsies of lung lesions: a comparison with the conventional manual technique. Eur Radiol. 2015 May;25(5):1310-6. doi: 10.1007/s00330-014-3508-z. Epub 2014 Nov 23. PMID 25417130
• Appelbaum L, Sosna J, Nissenbaum Y, Benshtein A, Goldberg SN. Electromagnetic navigation system for CT-guided biopsy of small lesions. AJR Am J Roentgenol. 2011 May;196(5):1194-200. doi: 10.2214/AJR.10.5151. PMID 21512092
• Alexander ES, Petre EN, Bodard S, Marinelli B, Sarkar D, Cornelis FH. Comparison of a Patient-Mounted Needle-Driving Robotic System versus Single-Rotation CT Fluoroscopy to Perform CT-Guided Percutaneous Lung Biopsies. J Vasc Interv Radiol. 2024 Jun;35(6):859-864. doi: 10.1016/j.jvir.2024.02.023. Epub 2024 Mar 5. PMID 38447771
• Lee KH, Lim KY, Suh YJ, Hur J, Han DH, Kang MJ, Choo JY, Kim C, Kim JI, Yoon SH, Lee W, Park CM. Diagnostic Accuracy of Percutaneous Transthoracic Needle Lung Biopsies: A Multicenter Study. Korean J Radiol. 2019 Aug;20(8):1300-1310. doi: 10.3348/kjr.2019.0189. PMID 31339018
• Rivera MP, Mehta AC, Wahidi MM. Establishing the diagnosis of lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e142S-e165S. doi: 10.1378/chest.12-2353. PMID 23649436
• Chang YY, Chen CK, Yeh YC, Wu MH. Diagnostic feasibility and safety of CT-guided core biopsy for lung nodules less than or equal to 8 mm: A single-institution experience. Eur Radiol. 2018 Feb;28(2):796-806. doi: 10.1007/s00330-017-5027-1. Epub 2017 Sep 7. PMID 28884222
• Horeweg N, van Rosmalen J, Heuvelmans MA, van der Aalst CM, Vliegenthart R, Scholten ET, ten Haaf K, Nackaerts K, Lammers JW, Weenink C, Groen HJ, van Ooijen P, de Jong PA, de Bock GH, Mali W, de Koning HJ, Oudkerk M. Lung cancer probability in patients with CT-detected pulmonary nodules: a prespecified analysis of data from the NELSON trial of low-dose CT screening. Lancet Oncol. 2014 Nov;15(12): PMID 25282285
• Baldwin DR, Callister ME; Guideline Development Group. The British Thoracic Society guidelines on the investigation and management of pulmonary nodules. Thorax. 2015 Aug;70(8):794-8. doi: 10.1136/thoraxjnl-2015-207221. Epub 2015 Jul 1. PMID 26135833

Идентификаторы

NCT: NCT07277088 · IS25177

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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