Injeq Plc, Tampere, Finland.
Department of Pediatric Hematology and Oncology, Oulu University Hospital, Oulu, Finland.
Trials. 2023 Jul 21;24(1):464. doi: 10.1186/s13063-023-07498-4.
Acute lymphoblastic leukemia (ALL) is the most common malignancy diagnosed in children. At present, the long-term survival from pediatric ALL is well over 90%. However, the probability of event-free survival is reduced if the lumbar puncture (LP) procedures at the beginning of the patient's intrathecal therapy cause blood leakage into the spinal canal and blast cells contaminate the cerebrospinal fluid. According to the literature, such traumatic LP procedures concern one out of five pediatric patients with ALL. Recently, a novel medical device measuring the tissue bioimpedance at the tip of a spinal needle was found feasible in pediatric patients with ALL. The LP procedure was successful at the first attempt in 80% of procedures, and the incidence of traumatic LPs was then 11%. The purpose of the present study is to compare the bioimpedance spinal needle system with the standard clinical practice resting on a conventional spinal needle and investigate its efficacy in clinical practice.
The study is a multicenter, randomized, two-arm crossover noninferiority trial of pediatric hemato-oncology patients that will be conducted within the usual clinical workflow. Patients' LP procedures will be performed alternately either with the IQ-Tip system (study arm A) or a conventional Quincke-type 22G spinal needle (study arm B). For each enrolled patient, the order of procedures is randomly assigned either as ABAB or BABA. The total number of LP procedures will be at least 300, and the number of procedures per patient between two and four. After each study LP procedure, the performance will be recorded immediately, and 1-week diary-based and 4-week record-based follow-ups on symptoms, complications, and adverse events will be conducted thereafter. The main outcomes are the incidence of traumatic LP, first puncture success rate, and incidence of post-dural puncture headache.
The present study will provide sound scientific evidence on the clinical benefit, performance, and safety of the novel bioimpedance spinal needle compared with the standard clinical practice of using conventional spinal needles in the LP procedures of pediatric patients with leukemia.
ISRCTN ISRCTN16161453. Registered on 8 July 2022.
急性淋巴细胞白血病（ALL）是儿童中最常见的恶性肿瘤。目前，儿科 ALL 的长期生存率超过 90%。然而，如果患者鞘内治疗开始时的腰椎穿刺（LP）程序导致血液漏入椎管，并且 blast 细胞污染脑脊液，则无事件生存的概率会降低。根据文献，大约五分之一的 ALL 儿科患者会出现这种创伤性 LP 程序。最近，一种新型医疗器械，即在脊髓针的尖端测量组织生物阻抗，已被证明在 ALL 儿科患者中是可行的。在 80%的操作中，该 LP 程序首次尝试即获得成功，随后创伤性 LP 的发生率为 11%。本研究的目的是比较生物阻抗脊髓针系统与基于传统脊髓针的标准临床实践，并在临床实践中研究其疗效。
该研究是一项多中心、随机、双臂交叉非劣效性临床试验，纳入儿科血液肿瘤患者，将在常规临床工作流程内进行。患者的 LP 程序将交替使用 IQ-Tip 系统（研究臂 A）或常规 22G Quincke 型脊髓针（研究臂 B）进行。对于每个入组患者，程序顺序随机分配为 ABAB 或 BABA。LP 程序的总数至少为 300 个，每个患者的程序数为 2 至 4 个。每次研究性 LP 程序后，将立即记录性能，并在 1 周内进行基于日记的随访和 4 周内基于记录的随访，以了解症状、并发症和不良事件。主要结局是创伤性 LP 的发生率、首次穿刺成功率和硬脊膜穿刺后头痛的发生率。
本研究将为新型生物阻抗脊髓针与使用传统脊髓针的标准临床实践在白血病患儿 LP 程序中的临床获益、性能和安全性提供可靠的科学证据。
ISRCTN ISRCTN86544422。于 2022 年 7 月 8 日注册。
