Purpose: Multimodal preoperative evaluation (MPE) is a novel strategy for surgical decision making, incorporating the transrectal ultrasound (TRUS), 64 multi-slice spiral computer tomography (MSCT), and serum amyloid A protein (SAA) for rectal cancer. This trial aims to determine the accuracy of MPE in preoperative staging and its role in surgical decision making for rectal cancer.
Methods: Two hundred twenty-five participants with histologically proven rectal cancer with tumor height less than 10 cm were randomly assigned into three arms in the ratio 1:1:1. Arm A (MPE) was multimodal staged by the combination of MSCT, TRUS, and SAA. Arm B (MSCT+SAA) was staged by MSCT and SAA. Arm C (MSCT) was staged only by MSCT. The primary endpoints were the accuracy of preoperative staging and expected surgical procedures. This study is registered as an International Standard Randomised Controlled Trial, number ChiCTR-DT-00000409.
Results: The analysis showed statistical difference in the accuracy of T staging between arm A and B (94.6% vs. 77.8%, P=0.003) and arm A and C (94.6% vs. 80.6%, P=0.010). Statistical difference was also observed between the accuracies of preoperative N staging between arm A and C (85.1% vs. 69.4%, P=0.023) and arm A and B (85.1% vs. 84.7%, P=0.029). Surgical decision making in arm A was more accurate than that in arm C (95.9% vs. 80.6%, P=0.001). Pathological T stage (P<0.001), N stage (P<0.001), tumor node metastasis stage (P<0.001), serum level of SAA (P=0.002), and tumor height (P=0.030) were significantly associated with final surgical procedures.
Conclusion: MPE is an effective strategy in preoperative staging and more accurate than other available strategies in surgical decision making for rectal cancer.