Wijsmuller Arthur R, Ghnassia Jean-Pierre, Varatharajah Sharmini, Schaeffer Mickael, Leroy Joel, Marescaux Jacques, Ignat Mihaela, Mutter Didier
1 Institut Hospitalo-Universitaire, Institut de Recherche contre les Cancers de l'Appareil Digestif, Strasbourg, France.
2 NHC, University Hospital of Strasbourg, Strasbourg, France.
Surg Innov. 2018 Aug;25(4):313-322. doi: 10.1177/1553350618773011. Epub 2018 May 7.
Intraoperative decision of the level of distal resection in rectal cancer is often imprecise, based exclusively on digital examination and pretherapeutic imaging.
Prospective, single institution, nonrandomized trial ( ClinicalTrial.gov identification no. NCT01887509) to evaluate the contribution of probe-based confocal laser endomicroscopy (pCLE) to establish the optimal resection margin of rectal adenocarcinoma. The primary outcome was the concordance in the identification of lower tumor margins between pCLE and histopathology. For each patient, pCLE examination was performed on nonneoplastic and neoplastic aspects of the distal tumor margin, before and after neoadjuvant chemoradiation, or preceding surgery, if chemoradiation was not required. Biopsies were taken at the same locations. The intraclass correlation coefficient was determined.
Twenty-one patients were enrolled. Thirteen patients completed the full study. Six patients completed imaging only before chemoradiation. Two patients retracted their consent after inclusion. A total of 134 videos and corresponding histopathology samplings were analyzed. The sensitivity and specificity of in vivo pCLE interpretation were 0.915 (95% confidence interval [CI] = 0.840-0.970) and 0.736 (95% CI = 0.657-0.821), respectively. The sensitivity and specificity of the blinded pCLE reinterpretation were 0.930 (95% CI = 0.858-0.980) and 0.688 (95% CI = 0.600-0.770), respectively. No deep layer tumor infiltration was encountered in the samplings with superficial healthy layers. The intraclass correlation coefficient for in vivo pCLE interpretation and blinded pCLE reinterpretation were 0.747 (95% CI = 0.257-0.993) and 0.766 (95% CI = 0.280-0.995), respectively.
This supports the concordance between pCLE and histopathology in identifying the "tumor-free" limit of a rectal tumor preceding resection.
直肠癌术中对远端切除水平的决策往往不够精确，完全基于指诊和治疗前影像学检查。
一项前瞻性、单机构、非随机试验（ClinicalTrial.gov识别号：NCT01887509），旨在评估基于探头的共聚焦激光内镜检查（pCLE）对确定直肠腺癌最佳切除边缘的作用。主要结局是pCLE与组织病理学在识别肿瘤下边缘方面的一致性。对每位患者，在新辅助放化疗前后或（若无需放化疗）手术前，对远端肿瘤边缘的非肿瘤和肿瘤部分进行pCLE检查。在相同位置取活检。确定组内相关系数。
纳入21例患者。13例患者完成了完整研究。6例患者仅在放化疗前完成了影像学检查。2例患者在纳入后撤回了同意。共分析了134个视频及相应的组织病理学样本。术中pCLE判读的敏感性和特异性分别为0.915（95%置信区间[CI]=0.840 - 0.970）和0.736（95%CI = 0.657 - 0.821）。pCLE盲法重新判读的敏感性和特异性分别为0.930（95%CI = 0.858 - 0.980）和0.688（95%CI = 0.600 - 0.770）。在具有浅表健康层的样本中未发现深层肿瘤浸润。术中pCLE判读和pCLE盲法重新判读的组内相关系数分别为0.747（95%CI = 0.257 - 0.993）和0.766（95%CI = 0.280 - 0.995）。
这支持了pCLE与组织病理学在识别切除前直肠肿瘤“无肿瘤”界限方面的一致性。
