A NOVEL EX VIVO PORCINE SIMULATOR FOR PERORAL ENDOSCOPIC MYOTOMY TRAINING (POMOD)

Aims:

POEM is a technically challenging procedure even for experienced endoscopists, thus special training is required.

We developed an ex-vivo porcine model called POMOD, which aims to simulate an in-vivo human esophagus. POMOD is a plastic cylindrical container, designed to accommodate and hold still a porcine esophagus. It is equipped with a cable connection to an electrical generator unipolar output.

Our study aims to demonstrate whether the use of POMOD improves training outcomes, in particular regarding safety and performance.

Methods:

A total of 15 POEM procedures were performed on porcine models.

The timing of each step (creation of the tunnel, myotomy, mucosa closure), the length of the submucosal tunnel and the complication rates (mucosal burn or perforation) were recorded.

A simple linear correlation between the training cases performed and the data acquired was calculated with Spearman's rank correlation coefficient (rs). P values < 0.05 were considered statistically significant.

After the training, 40 POEM procedures were performed on humans. Safety and short-term efficacy were analyzed.

Results:

POEM model training (POMOD) significantly decreased the length of time needed for each step. Spearman's test demonstrates that this expedited speed was related to the number of procedures previously performed by the operator with a 95% CI.

After the training period, 40 patients with esophageal motility disorder were treated with POEM. No mucosal perforation or mucosal burns were observed during the procedures on humans. Only minor complications occurred (pneumoperitoneum 7.5%, subcutaneus emphisema 10%, leakage 2.5%, pleuric effusion 2.5%, pneumonia 5%).

Median pre-operative Eckardt score was 6 (2 – 12). Three months after the procedure, the median Eckardt was 1 (0 – 3). Endoscopic follow-up at 6 months was available for 24 patients and revealed a 30% esophagitis rate.

Conclusions:

POMOD is an easy, inexpensive and reproducible animal model which is effective in training for the POEM procedure.