Introduction: Endoscopic ultrasound (EUS)-directed transgastric endoscopic retrograde cholangiopancreatography (EDGE) is a minimally invasive option for pancreaticobiliary access in patients with Roux-en-Y anatomy. The procedure involves creating a fistulous tract between the remnant stomach or jejunum and the bypassed stomach with the deployment of a lumen-apposing metal stent (LAMS), followed by the advancement of an endoscope through the LAMS to perform an ERCP or EUS. It is a technically challenging procedure, requiring skills in EUS, fluoroscopy, and LAMS deployment. The aim of this study was to determine the learning curve for EDGE. Methods: Consecutive patients undergoing EDGE by a single operator were included from a prospective registry over 3 years. Demographics, procedure info, postprocedure follow-up data, and adverse events were collected. Nonlinear regression and cumulative sum analyses were conducted for the learning curve. Technical success was defined as the successful creation of the fistulous tract. Clinical success was defined as successful EUS or ERCP via the LAMS. Results: Nineteen patients were included (21% male, mean age 58.7 y). Indication included symptomatic biliary stricture (n=6, 32%), choledocholithiasis (n=5, 26%), pancreatitis (n=3, 16%). Technical success was 100%. All patients had a 15 mm LAMS placed, 3 (16%) had cautery-enhanced LAMS. Clinical success was achieved in 18/19 (95%) patients. Fourteen patients had an ERCP, 1 patient had a EUS, and 3 patients had both. Adverse events included 2 cases of bleeding, 1 case of post-ERCP pancreatitis, and 1 jejunal perforation during duodenoscope insertion managed endoscopically. Median procedure time was 54.5 minutes (range: 31 to 88 min). Cumulative sum chart shows a 54-minute procedure time was achieved at the ninth procedure hence indicating efficiency. Apart from 2 outliers, the procedure duration further reduced with consequent procedures with the last 3 being under 40 minutes indicating that after 25 to 35 procedures a plateau may be reached indicating mastery (nonlinear regression P<0.0001). Conclusions: Endoscopists experienced in EDGE are expected to achieve a reduction in procedure time over successive cases, with efficiency reached 54.5 minutes and a learning rate of 9 cases. After 25 to 35 procedures, a plateau may be reached indicating mastery.

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Background and Aim: Gastroparesis is a potentially debilitating gastric motility disorder with limited treatment options. Highest efficacy treatments include gastric per-oral endoscopic myotomy (GPOEM) and surgical pyloromyotomy. This study compares the efficacy and safety of GPOEM versus laparoscopic pyloromyotomy for refractory gastroparesis. Methods: Patients who underwent GPOEM or laparoscopic pyloromyotomy for refractory gastroparesis from four centers across the USA and Latin America were included in a dedicated registry. Data collected included patient demographics, imaging, laboratory values, clinical success, gastroparesis cardinal symptom index, procedure time, pre-op and post-op gastric emptying times, adverse events, and hospital length of stay. Results: A total of 102 patients were included (mean age 47; 32.4% male): GPOEM n = 39, surgical pyloromyotomy n = 63.Technical success was 100% in both groups. Clinical success was 92.3% in the GPOEM group and 82.5% in the surgery group (P = 0.164). The GPOEM group had a significantly higher post-op GSCI score reduction by 1.3 units (P < 0.00001), post-op retention reduction at 2 h by 18% (P < 0.00001), post-op retention reduction at 4 h by 25% (P < 0.00001) and a lower procedure time by 20 min (P < 0.00001) as compared with surgery. GPOEM also had a lower hospital length of stay by 2.8 days (P < 0.00001). Adverse events were significantly fewer in the GPOEM group (13%) compared with surgery group (33.3%; P = 0.021). Mean blood loss in the GPOEM group was only 3.6 mL compared with 866 mL in the surgery group. Conclusions: The GPOEM may be a less invasive, safer, and more efficacious procedural treatment for refractory gastroparesis as compared with surgical pyloromyotomy. Cook, Apollo, NinePoint Medical, and Merit. He has done research and consulting for Boston Scientific. Avik Sarkar has done consulting work for US Endoscopy and Obalon Therapeutics. Haroon Shahid has done consulting work for US Endoscopy.