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Optimal number of needle passes in endoscopic ultrasound-guided tissue sampling for genomic profiling: a randomized,
Hirotoshi Ishiwatari1, Kazuma Ishikawa2, Junya Sato1
1Division of Endoscopy, Shizuoka Cancer Center, Shizuoka, Japan.
Background And Aims:
The use of commercially available comprehensive genomic profiling tests, such as the FoundationOne CDx (F1CDx), has increased. However, the success rate of F1CDx using samples obtained by EUS-guided tissue acquisition (EUS-TA) is suboptimal. This study aimed to verify the optimal method for obtaining samples suitable for F1CDx among 3 EUS-TA techniques.
Methods:
In a randomized, noncomparative, 3-arm trial, patients with unresectable pancreatic cancer scheduled for EUS-TA using a Franseen needle for pathologic confirmation were randomized into 3 groups: 2 passes with a 19-gauge needle; 4 passes with a 22-gauge needle; and macroscopic on-site evaluation (MOSE) using a 22-gauge needle until the macroscopic visible core length reached ≥40 mm. The primary end point was the acquisition rate of an ideal sample meeting the F1CDx quantity criteria; the secondary end points were procedure time, adverse events, and F1CDx success rate.
Results:
Seventy-five patients were enrolled. The acquisition rates of ideal samples for F1CDx (96%, 92%, and 96% for the 19-gauge, 22-gauge, and MOSE groups, respectively; all P < .05) were significantly greater than the expected 60%. The 19-gauge and MOSE groups had significantly shorter procedure times than the 22-gauge group (814 seconds vs 896 seconds vs 963 seconds). The 22-gauge group showed moderate abdominal bleeding. F1CDx was successful in 10, 12, and 9 cases in the 19-gauge, 22-gauge, and MOSE groups, respectively, representing a 100% success rate for each group.
Conclusions:
Two passes using a 19-gauge needle and MOSE using a 22-gauge needle are recommended to collect ideal samples for F1CDx. (Clinical trial registration: The Japan Registry of Clinical Trials [jRCTs042210083]).
