Monitoring diagnostic accuracy and complications. A report from the Children's Oncology Group Hodgkin lymphoma study

Background/Purpose Cancer studies mandate quality assurance programs for clinical trials. Surgeons consistently play 2 roles early in the management of Hodgkin lymphoma in children and adolescents: obtaining a specimen for pathologic diagnosis and placing a central venous catheter to assist with therapy delivery. A surgical quality assurance program was embedded as part of the of the Hodgkin lymphoma study (AHODOOO31) to assess diagnostic accuracy and complications. Methods Surgical checklists and operative and pathology reports were reviewed concurrently. Diagnostic technique, success rate, location of biopsy, combined procedures under one anesthetic, and complications are reported. Results One hundred eighty-five cases were reviewed, with 169 having complete data. Diagnostic techniques included open biopsy (n = 148), computed tomography–guided core biopsy (n = 5), thoracoscopic/laparoscopic biopsy (n = 10) and fine-needle aspirations (n = 4). No staging laparotomies were performed. Biopsy sites included cervical (133), mediastinal (18), axillary (7), and others (11). Diagnostic accuracy was 145 of 148 (98.5%) for the open biopsy; 4 of 5, core biopsy (80%); 6 of 10 (60%), thoracoscopic/laparoscopic biopsy; and 1 of 4, fine-needle aspiration (25%). Eighteen had mediastinal disease only, 9 of whom had a thoracoscopic biopsy with a 55% diagnostic accuracy. Inadequate sample was the only reason for a lack of diagnosis. A second open operation was required in these cases for diagnosis. At biopsy, frozen section confirmed a malignancy in 68. In 38 of these 68 children, a central line was placed during the same anesthetic. The most common complication was inadequate sampling. Three wound infections were reported. Conclusions With an appropriate surgical approach to obtain an adequate tissue specimen, diagnostic accuracy is high and surgical complications are low in children with Hodgkin lymphoma. Diagnostic technique should ensure adequate tissue sampling especially when not using an open procedure. When possible, central line insertion should be performed under the same anesthetic. Fine-needle aspiration was not used enough to assess its role in the diagnosis of children with Hodgkin lymphoma.

背景/目的 癌症研究要求为临床试验制定质量保证计划。在儿童和青少年霍奇金淋巴瘤的早期治疗中，外科医生通常扮演两种角色：获取病理诊断的标本以及置入中心静脉导管以辅助治疗实施。作为霍奇金淋巴瘤研究（AHOD0031）的一部分，嵌入了一个外科质量保证计划，以评估诊断准确性和并发症。 方法 同时审查手术清单以及手术和病理报告。报告了诊断技术、成功率、活检部位、在一次麻醉下进行的联合操作以及并发症。 结果 审查了185例病例，其中169例有完整数据。诊断技术包括开放性活检（n = 148）、计算机断层扫描引导下的芯针活检（n = 5）、胸腔镜/腹腔镜活检（n = 10）以及细针抽吸（n = 4）。未进行分期剖腹手术。活检部位包括颈部（133）、纵隔（18）、腋窝（7）以及其他部位（11）。开放性活检的诊断准确率为148例中的145例（98.5%）；芯针活检为5例中的4例（80%）；胸腔镜/腹腔镜活检为10例中的6例（60%）；细针抽吸为4例中的1例（25%）。18例仅有纵隔疾病，其中9例进行了胸腔镜活检，诊断准确率为55%。样本不足是无法诊断的唯一原因。在这些病例中，需要进行第二次开放性手术以明确诊断。在活检时，冰冻切片在68例中证实为恶性。在这68例儿童中的38例，在同一麻醉下置入了中心静脉导管。最常见的并发症是样本不足。报告了3例伤口感染。 结论 通过适当的手术方法获取足够的组织标本，霍奇金淋巴瘤儿童的诊断准确率较高，手术并发症较低。诊断技术应确保足够的组织取样，尤其是在不使用开放性手术时。在可能的情况下，应在同一麻醉下置入中心静脉导管。细针抽吸在霍奇金淋巴瘤儿童诊断中的作用因使用不足而无法评估。