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CAMINO

Acronym

CAMINO

Name of the study

A randomized controlled trial comparing CT chest/abdomen and liver-MRI versus CT chest/abdomen would neither be efficient nor practical. Any beneficial effect on patient outcomes would only be observed in those with additional CS-CRLM on MRI; the existence and size of that subgroup is the main target of this accuracy study. In addition, routine liver-MRI is already integrated in daily practice in many centers. Within the study design proposed here, liver-MRI will not be withheld from any patient.

Sample size calculation indicate that 298 patients will have to be included to obtain estimates of change in management of 10% with 95% confidence intervals (CIs) that do not exceed 7% (95%CIs: 6.5%-13.5%). We plan to recruit these patients during a 16-month period.

Only patients who are considered candidates for curative surgery (+/- per-operative ablation) based on CT findings are eligible.

First, based on the CT findings, the liver surgery plan (+/- per-operative ablation) will be documented. Thereafter, findings at MRI will be discussed.

Researchers and contact information

Prof.dr. J. Stoker, Amsterdam UMC, loc. AMC

E-mail: j.stoker@amc.uva.nl

Summary study

Problem description

Colorectal cancer (CRC) is the third most common cancer worldwide. Approximately 50% of patients with CRC present with or will develop liver metastases (CRLM). Surgery is the cornerstone of curative intent therapy for these patients with 5-year survival exceeding 30%. Increasingly, minimally invasive surgery is performed (combined with local ablation) for which optimal preoperative CRLM localization is of utmost importance.

Current routine preoperative workup of CRLM consists of CT chest/abdomen. Recently, it has become clear that the diagnostic accuracy of liver-MRI for (small) CRLM is superior to CT. Whether liver-MRI should be added routinely or selectively (problem-solving) in the work-up of CRLM is, however, unclear as previous studies did not address this point. A recent survey by our group identified a large (15%-90%) inter-hospital variability in the use of liver-MRI in the Netherlands.

Additional liver-MRI can detect clinically significant (CS)-CRLM: lesions in liver part(s) not incorporated in the initially planned resection/ablation based on CT. Detection of CS-CRLM will lead to either more extensive resection/ablation or to refraining from resection/ablation altogether (impact on management and informed decision making).

As adding routine liver-MRI to the work-up of (presumed) CRLM may cause additional pre-surgery delays, any recommendation about its use should be guided by the relative frequency with which additional CS-CRLM are detected and hereby considering the role of routinely performed intraoperative ultrasound (IOUS).

Research direction

The current large inter-hospital variability is caused by a lack of evidence on the incremental diagnostic accuracy of routine liver-MRI, potentially leading to suboptimal care. Routine liver-MRI in CRLM patients scheduled for surgery based on CT chest/abdomen would only be justified if it leads to a sufficient proportion of patients in whom additional CS-CRLM are found.   

Aim & hypothesis

Primary aim is to perform a prospective, multicenter incremental diagnostic accuracy study in patients with (recurrent) CRLM to estimate the proportion of patients in which liver-MRI finds CS-CRLM in addition to CT chest/abdomen.

We hypothesize that liver-MRI will lead to the detection of additional CS-CRLM in at least 10% of patients with CRLM scheduled for surgery based on CT chest/abdomen.

Our secondary aim is to develop a prediction rule to identify specific subgroups (e.g. post-chemotherapy, bilobar CRLM) that would benefit most of liver-MRI. Furthermore, the additional cost of liver-MRI will be determined.

 

Intervention

Multicenter, incremental diagnostic accuracy study in 15 Dutch hospitals.

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