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Multicenter Study
. 2019 Mar 21;19(1):254.
doi: 10.1186/s12885-019-5408-8.

Second and third look laparoscopy in pT4 colon cancer patients for early detection of peritoneal metastases; the COLOPEC 2 randomized multicentre trial

Vivian P Bastiaenen  1 , Charlotte E L Klaver  2 , Niels F M Kok  3 , Johannes H W de Wilt  4 , Ignace H J T de Hingh  5 , Arend G J Aalbers  3 , Djamila Boerma  6 , Andre J A Bremers  4 , Jacobus W A Burger  5 , Eino B van Duyn  7 , Pauline Evers  8 , Wilhelmina M U van Grevenstein  9 , Patrick H J Hemmer  10 , Eva V E Madsen  11 , Petur Snaebjornsson  12 , Jurriaan B Tuynman  13 , Marinus J Wiezer  6 , Marcel G W Dijkgraaf  14 , Jarmila D W van der Bilt  2   15 , Pieter J Tanis  16
Affiliations
Multicenter Study

Second and third look laparoscopy in pT4 colon cancer patients for early detection of peritoneal metastases; the COLOPEC 2 randomized multicentre trial

Vivian P Bastiaenen et al. BMC Cancer. .

Abstract

Background: 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.

Methods: 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.

Discussion: 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.

Trial registration: ClinicalTrials.gov: NCT03413254 , January 2018.

Keywords: Diagnostic laparoscopy; Early detection; Peritoneal metastases; Second/third look surgery; T4 colon cancer.

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Conflict of interest statement

Ethics approval and consent to participate

The medical ethical committee of the Academic Medical Centre Amsterdam has approved the study protocol (MEC 2017_134, NL61507.018.17) on the 2nd of October 2017. Approval of a local ethical committee and/or the Board of Directors will be obtained in each participating hospital. At the time of submission of this study protocol, the following hospitals received approval for participation and are therefore open for inclusion: Amsterdam UMC (Amsterdam), Catharina Hospital (Eindhoven), Flevo Hospital (Almere), OLVG (Amsterdam), Radboud University Medical Centre (Nijmegen) and University Medical Centre Utrecht (Utrecht). Written informed consent will be obtained from all participants.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flowchart. CT, computed tomography; DLS, diagnostic laparoscopy; PM, peritoneal metastases
See this image and copyright information in PMC

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