The flexible high-pressure injection knife, a new high-performance tool for submucosal dissection. Randomized controlled study in animals and propensity score in humans

Aims Colorectal Endoscopic Submucosal dissection (ESD) remains a technically challenging procedure in need of facilitation. A new available ESD knife, using high-pressure injection appears to be a potential source of procedural simplification. This study aims to evaluate this new system in animal beginners and human experts.

Methods Animal study: open randomized controlled study on anesthetized porcine models, in which 4 gastric and 4 colorectal standardized lesions were created (25 mm diameter each). 5 ESD novice operators were randomized to work with a flexible High-Pressure injection Knife (HPK) or a Standard Knife (SK) in rotation. Primary objective: to compare procedure time (R0 monobloc resection). Secondary objectives: to compare the rate of complete resection<60 minutes, the perforation rate, and operator satisfaction on 7 technical criteria. Clinical study: prospective cohort study in an expert center by 4 operators comparing ESD performed with HPK or SK. A 1:1 propensity score matching without replacement was performed, using a logistic regression model including the covariates “type of lesion”, “recurrence”, “pectinal involvement” and “maneuverability”. Primary objective: to compare histological R0 rates. Secondary objectives: rates of curative and monobloc resections, perforation, delayed bleeding, secondary surgery, procedure time and speed of resections.

Results Animal study: 41 gastric and 59 colorectal ESDs were performed. Mean procedure time was not significantly different between HPK and SK (38.7±19.0 min vs. 41.5±19.8 min, p=0.327), nor was resection speed (p=0.235). There was no difference in rates of complete resection (77.5% vs. 64.7%, p=0.232), perforation (p>0.99), and operator satisfaction was better for HPK regarding injection (p<0.001) and sharpness of dissection (p=0.046). Clinical study: 410 ESDs were performed from 1/01/2023 to 8/24/2024. After exclusion of seratide sessile lesions, submucosal or JNET III lesions, 379 colorectal ESDs, including 70 with HPK, were analyzed. Lesions treated with HPK were significantly larger (69.5 mm±31.43 vs. 57.73 mm±24.9, p=0.004), in more difficult locations (notably fewer rectal lesions), with poorer maneuverability. The propensity score was used to compare 69 lesions in each arm (HPK vs. SK). The two groups were comparable. The histological R0 resection rate was significantly higher with HPK (n=64 (95.52%) vs. n=56 (82.35%) p=0.026). The curative resection rate was significantly higher (n=62 (93.94%) vs n=53 (77.94%), p=0.012). No significant difference on resection time and speed, rates of perforation monobloc resection, delayed bleeding and secondary surgery for complication.

Conclusions The animal study showed a trend towards better results for novice practitioners with flexible HPK compared with SK. In more experienced human operators, R0 and curative resection rates were significantly higher in colo-rectal lesions (notably in complex technical situations).

Publikationsverlauf

Artikel online veröffentlicht:
27. März 2025