Randomized Controlled Study of Endoscopic Mucosal Resection (EMR) Versus Endoscopic Submucosal Dissection with a Waterjet Hybridknife (ESDH) of Esophageal Lesions in a Porcine Model

Abstract

Introduction: Uncontrolled studies indicated that ESD is superior to EMR for en-bloc resection of gastrointestinal mucosal lesions. However, ESD is technically difficult and seems to be more time-consuming and hazardous than EMR. In addition experience with this method is limited in the esophagus although there may be more clinical applications for esophageal lesions than for gastric lesions in Western countries. The objective of our study is to compare a new simplified ESD technique with conventional EMR. Methods and aims: The study was performed in 6 pigs under general anesthesia. A total of 25 esophageal areas with a diameter of 20 mm were marked with coagulation spots. These lesions were then randomized to either EMR by use of the cap technique or ESD. Submucosal injection of saline solution was used for both methods. ESD was done with a hybrid knife which allows cutting / coagulation as well as injection / flushing through an axial water-jet channel with a preselected pressure of a high pressure waterjet system (Erbe Jet 2). Intraoperative bleedings were treated with hemostatic forceps. Primary objective: to achieve complete resection of the lesions including the coagulation markers with no mucosal bridges; secondary objectives: to minimize the number of specimen, to determine the complication rate and procedural duration. Results: 13 lesions were randomized to EMRC and 12 to ESDH. ESDH achieved complete resection significantly more frequently than EMRC (10/12 versus 6/13 p = 0.05). All ESDH resections were performed as a single piece whereas a mean ( ± SD) of 2.5 ± 0.9 resections were needed for EMRC (p < 0.05). Mean areas of the specimen were 4.7 ± 0.7 cm2 in the ESDH group and 3.7 ± 1.2 cm2 in the EMRC group (p < 0.04). ESDH was performed with a larger amount of fluid for injection/flushing compared to EMRC (78.1 ± 32.8 ml vs 20.9 ± 7.6 ml; p < 0.001). The procedural duration was longer for ESDH than for EMRC (28.2 ± 11.9 min vs 12.2 ± 4.9 min; p < 0.001). ESDH and EMRC caused bleedings in 6/12 and 5/13 (p = 0.09) of the cases, respectively. Hemostasis could be achieved in all cases. There was no perforation in both groups. Conclusions: This randomized controlled trial shows that ESDH significantly achieves complete resection of esophageal lesions more frequently with less number of specimen than EMRC. ESDH is more time-consuming but the procedural duration seems to be shorter than conventional ESD because there is no need for exchange of devices for injection and cutting. The easy use of water-jet assisted injection of large amount of fluids may explain that ESDH was as safe as EMRC in spite of the thin esophageal wall in a porcine model.