Rutten Marianne J, Leeflang Mariska M G, Kenter Gemma G, Mol Ben Willem J, Buist Marrije
Department of Obstetrics and Gynaecology, Academic Medical Center, Amsterdam, Netherlands.
Cochrane Database Syst Rev. 2014 Feb 21;2014(2):CD009786. doi: 10.1002/14651858.CD009786.pub2.
The presence of residual tumour after primary debulking surgery is the most important prognostic factor in patients with advanced ovarian cancer. In up to 60% of cases, residual tumour of more than 1 cm is left behind, stressing the necessity of accurately selecting those patients who should be treated with primary debulking surgery and those who should receive neoadjuvant chemotherapy instead.
To determine if performing an open laparoscopy after the diagnostic work-up of patients suspected of advanced ovarian cancer is accurate in predicting the resectability of disease.
We searched MEDLINE, EMBASE, The Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Register of Diagnostic Test Accuracy Studies, MEDION and ISI Web of Science to February 2013. Furthermore, we checked references of identified primary studies and review articles.
We included studies that evaluated the diagnostic accuracy of laparoscopy to determine the resectability of disease in patients who are suspected of advanced ovarian cancer and planned to receive primary debulking surgery.
Two review authors assessed the quality of included studies using QUADAS-2 and extracted data on study and patients' characteristics, index test, target condition and reference standard. Data for two-by-two tables were extracted and summarised graphically. Sensitivity and specificity and negative predictive values were calculated.
We included seven studies reporting on six cohorts. Between 27% to 64% of included patients per study were positive on laparoscopy (too extensive disease to warrant laparotomy) and between 36% to 73% were negative (disease suitable for debulking laparotomy). Only two studies avoided partial verification bias and provided data to calculate sensitivity and specificity, which did not justify meta-analysis. These two studies had a sensitivity of 0.70 (95% confidence interval (CI) 0.57 to 0.82) and 0.71 (95% CI 0.44 to 0.90); however, the specificity of both studies was 1.00 (95% CI 0.90 to 1.00). In these two studies there were no false positives, i.e. no patients for whom laparoscopy indicated that major surgery would not be successful and should be avoided, whereas, in reality the patient could be successfully operated upon. Negative predictive values (NPV), for those patients who were diagnosed with having not too extensive disease correctly identified were 0.75 (95% CI 0.55 to 0.86) and 0.96 (95% CI 0.56 to 0.99) due to a different prevalence. Although the studies did report sufficient data to calculate NPVs, we judged these estimates too heterogeneous to meta-analyse.Three studies described the development or validation of a prediction model with a clear cut-off for test positivity. Sensitivity and specificity of these prediction models were 0.30 to 0.70 and 0.89 to 1.00, respectively. However, one of these studies suffered from partial verification bias.
AUTHORS' CONCLUSIONS: Laparoscopy is a promising test, but the low number of studies and the differences between the included studies do not allow firm conclusions to be drawn from these data. Due to a difference in prevalence, there is a wide range in negative predictive values between studies. Two studies verified all patients. These imply a high specificity of laparoscopy in diagnosing resectability and have a good sensitivity. Both studies show that the use of criteria for unresectable disease will result in no patients inappropriately unexplored. However, there will still be patients undergoing unsuccessful primary laparotomy. Using a prediction model does not increase the sensitivity and will result in more unnecessarily explored patients, due to a lower specificity.
初次肿瘤细胞减灭术后残留肿瘤的存在是晚期卵巢癌患者最重要的预后因素。在高达60%的病例中,会残留直径超过1 cm的肿瘤,这凸显了准确选择那些应接受初次肿瘤细胞减灭术治疗的患者以及那些应接受新辅助化疗的患者的必要性。
确定对疑似晚期卵巢癌患者进行诊断性检查后实施开放性腹腔镜检查在预测疾病可切除性方面是否准确。
我们检索了截至2013年2月的MEDLINE、EMBASE、Cochrane对照试验中心注册库(CENTRAL)、Cochrane诊断试验准确性研究注册库、MEDION和ISI科学网。此外,我们还检查了已识别的原始研究和综述文章的参考文献。
我们纳入了评估腹腔镜检查诊断准确性的研究,以确定疑似晚期卵巢癌且计划接受初次肿瘤细胞减灭术患者的疾病可切除性。
两位综述作者使用QUADAS-2评估纳入研究的质量,并提取有关研究和患者特征、指标试验、目标疾病和参考标准的数据。提取四格表的数据并以图形方式进行汇总。计算敏感性、特异性和阴性预测值。
我们纳入了七项报告六个队列的研究。每项研究中纳入的患者有27%至64%腹腔镜检查呈阳性(疾病范围太广,不适合开腹手术),36%至73%呈阴性(疾病适合减瘤性开腹手术)。只有两项研究避免了部分验证偏倚并提供了计算敏感性和特异性的数据,这不足以进行荟萃分析。这两项研究的敏感性分别为0.70(95%置信区间(CI)0.57至0.82)和0.71(95%CI 0.44至0.90);然而,两项研究的特异性均为1.00(95%CI 0.90至1.00)。在这两项研究中没有假阳性,即没有患者腹腔镜检查显示大手术不会成功且应避免,而实际上患者可以成功进行手术。由于患病率不同,对于那些被正确诊断为疾病范围不太广泛的患者,阴性预测值(NPV)分别为0.75(95%CI 0.55至0.86)和0.96(95%CI 0.56至0.99)。尽管这些研究确实报告了足够的数据来计算NPV,但我们认为这些估计值差异太大,无法进行荟萃分析。三项研究描述了具有明确阳性检测临界值的预测模型的开发或验证。这些预测模型的敏感性和特异性分别为0.30至0.70和0.89至1.00。然而,其中一项研究存在部分验证偏倚。
腹腔镜检查是一项有前景的检查,但研究数量较少且纳入研究之间存在差异,无法从这些数据中得出确凿结论。由于患病率不同, 各研究间的阴性预测值范围较宽。两项研究对所有患者进行了验证。这意味着腹腔镜检查诊断可切除性具有较高的特异性且敏感性良好。两项研究均表明, 使用不可切除疾病的标准不会导致任何患者被不恰当地漏诊。然而, 仍会有患者初次开腹手术不成功。使用预测模型不会提高敏感性,且由于特异性较低,会导致更多患者被不必要地进行检查。