Rodrigo Tovar Pérez , Carlos Cerdán-Santacruz , Óscar Cano-Valderrama , Fernando Jiménez Escovar , Blas Flor Lorente , Rodrigo O Perez , Javier García-Septiem
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引用次数: 0
摘要
导言局部切除术（LR）是全直肠系膜切除术（TME）的一种替代方案，它避免了在直肠癌早期阶段因肿瘤根治性而带来的相关发病率。这一策略的成功有几个条件因素，如预后不良的组织学因素（PPHF）、切除边缘受累、临床分期不足或可能导致TME根治术指征的并发症。患者和方法设计了一项国际多中心前瞻性开放标签观察研究。研究将连续纳入被诊断为早期直肠癌（核磁共振成像和肛门直肠超声检查结果为 cT1N0）的患者，这些患者的下限最多为肛门直肠交界处近端 2 厘米处。该研究的主要目的是确定在 LR 后需要 TME 或术后放射化疗的 PPHF 的总体发生率。讨论文献中对影响早期远端直肠癌 LR 成功率的 PPHF 发生率的研究很少，前瞻性数据也很少。考虑到人们对直肠癌观察和等待策略的兴趣与日俱增，以及该策略在早期肿瘤中的可能应用，了解这些信息似乎很有必要。这项研究的结果将有助于指导早期直肠癌远端患者的临床实践，也将为今后设计比较研究提供高质量的信息，以提高这些患者的器官保留成功率：NCT05927584.
Resección local exclusiva sin tratamiento adyuvante como estrategia de preservación de órgano en cáncer de recto precoz: protocolo de estudio observacional prospectivo
Introduction
Local resection (LR) is an alternative to total mesorectal excision (TME) that avoids its associated morbidity to the detriment of oncological radicality in early stages of rectal cancer. There are several conditioning factors for the success of this strategy, such as poor prognosis histological factors (PPHF), involvement of resection margins, clinical under staging, or complications that may lead to the indication for radical surgery with TME.
Patients and method
An international multicenter prospective observational open-label study has been designed. Consecutive patients diagnosed with early rectal cancer (cT1N0 on MRI ± endorectal ultrasound) whose lower limit is a maximum of 2 cm proximal to the ano-rectal junction will be included. The primary objective of the study is to determine the overall prevalence of PPHF after LR and requiring TME or postoperative radio-chemotherapy.
Discussion
The prevalence of PPHF conditioning the success of LR in early distal rectal cancer has been scarcely studied in the literature, and there are very few prospective data. Considering the increasing interest in the watch and wait strategy in rectal cancer and its possible application in early-stage tumors, it seems necessary to know this information.
The results of this study will help guide clinical practice in patients with early distal rectal cancer. It will also provide quality information for the design of future comparative studies to improve organ preservation success in these patients.
期刊介绍：
Cirugía Española, an official body of the Asociación Española de Cirujanos (Spanish Association of Surgeons), will consider original articles, reviews, editorials, special articles, scientific letters, letters to the editor, and medical images for publication; all of these will be submitted to an anonymous external peer review process. There is also the possibility of accepting book reviews of recent publications related to General and Digestive Surgery.
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