Department of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, PO Box 22660, 1105 AZ, Amsterdam, the Netherlands.
Department of Surgery, the Netherlands Cancer Institute, Amsterdam, the Netherlands.
BMC Cancer. 2019 Mar 21;19(1):254. doi: 10.1186/s12885-019-5408-8.
Approximately 20-30% of patients with pT4 colon cancer develop metachronous peritoneal metastases (PM). Due to restricted accuracy of imaging modalities and absence of early symptoms, PM are often detected at a stage in which only a quarter of patients are eligible for curative intent treatment. Preliminary findings of the COLOPEC trial (NCT02231086) revealed that PM were already detected during surgical re-exploration within two months after primary resection in 9% of patients with pT4 colon cancer. Therefore, second look diagnostic laparoscopy (DLS) to detect PM at a subclinical stage may be considered an essential component of early follow-up in these patients, although this needs confirmation in a larger patient cohort. Furthermore, a third look DLS after a negative second look DLS might be beneficial for detection of PM occurring at a later stage.
The aim of this study is to determine the yield of second look DLS and added value of third look DLS after negative second look DLS in detecting occult PM in pT4N0-2 M0 colon cancer patients after completion of primary treatment. Patients will undergo an abdominal CT at 6 months postoperative, followed by a second look DLS within 1 month if no PM or other metastases not amenable for local treatment are detected. Patients without PM will subsequently be randomized between routine follow-up including 18 months abdominal CT, or an experimental arm with a third look DLS provided that PM or incurable metastases are absent at the 18 months abdominal CT. Primary endpoint is the proportion of PM detected after a negative second look DLS and will be determined at 20 months postoperative.
Second look DLS is supposed to result in 10% occult PM, and third look DLS after negative second look DLS is expected to detect an additional 10% of PM compared to routine follow-up alone in patients with pT4 colon cancer. Detection of PM at an early stage will likely increase the proportion of patients eligible for curative intent treatment and subsequently improve survival, given the uniformly reported direct association between the extent of peritoneal disease and survival.
ClinicalTrials.gov: NCT03413254 , January 2018.
约 20-30%的 pT4 结肠癌患者会发生异时性腹膜转移（PM）。由于影像学检查的准确性有限，且缺乏早期症状，PM 通常在只有四分之一的患者适合进行治愈性治疗的阶段才被发现。COLOPEC 试验（NCT02231086）的初步结果显示，在原发切除术后两个月内，9%的 pT4 结肠癌患者在再次剖腹探查时已经发现 PM。因此，为了在这些患者的早期随访中考虑到亚临床期 PM 的检测，二次诊断腹腔镜检查（DLS）可能是必不可少的，尽管这需要在更大的患者队列中得到证实。此外，在二次 DLS 检查阴性后进行第三次 DLS 检查，可能有助于检测在较晚阶段发生的 PM。
本研究的目的是确定在完成原发治疗后，在 pT4N0-2M0 结肠癌患者中，二次 DLS 的检出率以及在二次 DLS 检查阴性后进行第三次 DLS 检查的附加价值，以检测隐匿性 PM。患者将在术后 6 个月进行腹部 CT 检查，如果未发现 PM 或其他不可行局部治疗的转移灶，则在 1 个月内进行二次 DLS 检查。无 PM 的患者随后将在常规随访组（包括 18 个月的腹部 CT）和实验组之间进行随机分组，实验组在 18 个月的腹部 CT 检查时如果没有 PM 或无法治愈的转移灶，则进行第三次 DLS 检查。主要终点是二次 DLS 检查阴性后的 PM 检出率，并在术后 20 个月确定。
二次 DLS 预计会发现 10%的隐匿性 PM，而在二次 DLS 检查阴性后进行第三次 DLS 检查，预计会比单独进行常规随访发现更多的 PM，在 pT4 结肠癌患者中，预计会发现 10%的 PM。在早期发现 PM 可能会增加适合治愈性治疗的患者比例，从而改善生存，因为腹膜疾病的严重程度与生存之间存在着普遍报道的直接关联。
ClinicalTrials.gov：NCT03413254，2018 年 1 月。
