BACKGROUND:Endoscopic submucosal dissection (ESD) seems to be more effective than EMR for curative resection of GI mucosal neoplasia. However, ESD is technically difficult, hazardous, and time consuming. New technologies may overcome these drawbacks. OBJECTIVE: Our purpose was to compare a new simplified ESD technique with conventional EMR. DESIGN: Prospective, randomized, and controlled trial in anesthetized pigs. METHODS: A total of 25 esophageal areas with a diameter of 20 mm were marked with coagulation points in 6 pigs under general anesthesia. 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 performed with a hybrid-knife (ESDH), which allows cutting and coagulation as well as a needleless, tissue-selective hydrodissection through an axial water-jet channel with a preselected pressure by using a high-pressure water-jet system (ErbeJet 2). Intraoperative bleedings were treated with hemostatic forceps. MAIN OUTCOME MEASUREMENTS: A comparison of the rates of complete resection of the lesions, the number and the size of resected specimens, the complication rate, and the procedural duration. RESULTS:Thirteen lesions were randomized to EMR and 12 to ESDH. ESDH achieved complete resection significantly more frequently than EMR (10/12 vs 6/13; P = .05). All ESDH resections were performed as a single piece, whereas a mean (SD) of 2.5 +/- 0.9 resections were needed for EMR (P < .05). The mean (SD) areas of the specimen were 3.63 +/- 1.20 cm(2) in the ESDH group and 1.83 +/- 0.78 cm(2) in the EMR group (P < .0001). ESDH was performed with a larger amount of fluid for injection and hydrodissection compared with EMR (78.1 +/- 32.8 mL vs 20.9 +/- 7.6 mL; P < .001). The procedural duration was longer for ESDH than for EMR (28.2 +/- 11.9 minutes vs 12.2 +/- 4.9 minutes; P < .001). ESDH and EMR caused bleedings in 6 of 12 and 5 of 13 of the cases (P = .09), respectively. Hemostasis could be achieved in all cases. There was no perforation in either group. LIMITATIONS: Resection of artificial non-neoplastic lesions, small numbers, an animal trial. CONCLUSIONS:ESDH achieves complete resection of esophageal lesions significantly more frequently with a fewer number of specimens than EMR. 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 repeated injections of fluids may explain why ESDH was as safe as EMRC.
RCT Entities:
BACKGROUND: Endoscopic submucosal dissection (ESD) seems to be more effective than EMR for curative resection of GI mucosal neoplasia. However, ESD is technically difficult, hazardous, and time consuming. New technologies may overcome these drawbacks. OBJECTIVE: Our purpose was to compare a new simplified ESD technique with conventional EMR. DESIGN: Prospective, randomized, and controlled trial in anesthetized pigs. METHODS: A total of 25 esophageal areas with a diameter of 20 mm were marked with coagulation points in 6 pigs under general anesthesia. 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 performed with a hybrid-knife (ESDH), which allows cutting and coagulation as well as a needleless, tissue-selective hydrodissection through an axial water-jet channel with a preselected pressure by using a high-pressure water-jet system (ErbeJet 2). Intraoperative bleedings were treated with hemostatic forceps. MAIN OUTCOME MEASUREMENTS: A comparison of the rates of complete resection of the lesions, the number and the size of resected specimens, the complication rate, and the procedural duration. RESULTS: Thirteen lesions were randomized to EMR and 12 to ESDH. ESDH achieved complete resection significantly more frequently than EMR (10/12 vs 6/13; P = .05). All ESDH resections were performed as a single piece, whereas a mean (SD) of 2.5 +/- 0.9 resections were needed for EMR (P < .05). The mean (SD) areas of the specimen were 3.63 +/- 1.20 cm(2) in the ESDH group and 1.83 +/- 0.78 cm(2) in the EMR group (P < .0001). ESDH was performed with a larger amount of fluid for injection and hydrodissection compared with EMR (78.1 +/- 32.8 mL vs 20.9 +/- 7.6 mL; P < .001). The procedural duration was longer for ESDH than for EMR (28.2 +/- 11.9 minutes vs 12.2 +/- 4.9 minutes; P < .001). ESDH and EMR caused bleedings in 6 of 12 and 5 of 13 of the cases (P = .09), respectively. Hemostasis could be achieved in all cases. There was no perforation in either group. LIMITATIONS: Resection of artificial non-neoplastic lesions, small numbers, an animal trial. CONCLUSIONS: ESDH achieves complete resection of esophageal lesions significantly more frequently with a fewer number of specimens than EMR. 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 repeated injections of fluids may explain why ESDH was as safe as EMRC.