Dedicated MRI staging versus surgical staging of peritoneal metastases in colorectal cancer patients considered for CRS-HIPEC; the DISCO randomized multicenter trial

M P Engbersen,V Retel,M De Vries,A R M Brandt-Kerkhof,E J R J Van Der Hoeven,N F M Kok,C J V Rijsemus,R G H Beets-Tan,S Van Koeverden,D Boerma,M J Lahaye,J Nederend,E V E Madsen,M J Wiezer,P R De Reuver,A G J Aalbers,I H J T De Hingh,D M J Lambregts

doi:10.1186/s12885-021-08168-x

Abstract

BackgroundSelecting patients with peritoneal metastases from colorectal cancer (CRCPM) who might benefit from cytoreductive surgery followed by hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) is challenging. Computed tomography generally underestimates the peritoneal tumor load. Diagnostic laparoscopy is often used to determine whether patients are amenable for surgery. Magnetic resonance imaging (MRI) has shown to be accurate in predicting completeness of CRS. The aim of this study is to determine whether MRI can effectively reduce the need for surgical staging.MethodsThe study is designed as a multicenter randomized controlled trial (RCT) of colorectal cancer patients who are deemed eligible for CRS-HIPEC after conventional CT staging. Patients are randomly assigned to either MRI based staging (arm A) or to standard surgical staging with or without laparoscopy (arm B). In arm A, MRI assessment will determine whether patients are eligible for CRS-HIPEC. In borderline cases, an additional diagnostic laparoscopy is advised. The primary outcome is the number of unnecessary surgical procedures in both arms defined as: all surgeries in patients with definitely inoperable disease (PCI > 24) or explorative surgeries in patients with limited disease (PCI < 15). Secondary outcomes include correlations between surgical findings and MRI findings, cost-effectiveness, and quality of life (QOL) analysis.ConclusionThis randomized trial determines whether MRI can effectively replace surgical staging in patients with CRCPM considered for CRS-HIPEC.Trial registrationRegistered in the clinical trials registry of U.S. National Library of Medicine under NCT04231175.

Highlights

Selecting patients with peritoneal metastases from colorectal cancer (CRCPM) who might benefit from cytoreductive surgery followed by hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) is challenging
The primary objective of this study is to determine whether additional preoperative dedicated Magnetic resonance imaging (MRI) staging to can reduce the number of futile surgeries in patients with CRC considered for CRS-HIPEC as compared to the standard of care of Computed tomography (CT) alone
– number of non-peritoneal metastases, – diagnostic performance of MRI and diagnostic laparoscopy to predict whether complete CRS-HIPE C is feasible, – correlations between MRI findings and surgical findings, – incremental cost-effectiveness, – Patient reported quality of life (QOL) between study arms

Summary

Methods

The study is designed as a multicenter randomized controlled trial (RCT) of colorectal cancer patients who are deemed eligible for CRS-HIPEC after conventional CT staging. Patients are randomly assigned to either MRI based staging (arm A) or to standard surgical staging with or without laparoscopy (arm B). In arm A, MRI assessment will determine whether patients are eligible for CRS-HIPEC. The primary outcome is the number of unnecessary surgical procedures in both arms defined as: all surgeries in patients with definitely inoperable disease (PCI > 24) or explorative surgeries in patients with limited disease (PCI < 15). Secondary outcomes include correlations between surgical findings and MRI findings, cost-effectiveness, and quality of life (QOL) analysis

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