Prospective Randomized Trial Comparing Endoscopic Ultrasound (EUS) and Gastroscopy (EGD) for Trans-Mural Drainage of Pancreatic Pseudocysts

Abstract

Background: While prior studies have evaluated the role of EUS and EGD for drainage of pancreatic pseudocysts, there are no randomized trials that have compared the technical outcomes between both modalities. Aim: Compare the rate of technical success and procedure-related complications between EUS and EGD for trans-mural drainage of pancreatic pseudocysts. Methods: Randomized trial of consecutive patients with pancreatic pseudocysts (>4cm in size) who underwent drainage by EUS or EGD over a 6-month period. CT of the abdomen was obtained prior to pseudocyst drainage in all patients. Technical success was defined as successful placement of trans-mural stents within the pseudocyst. Treatment success was defined as resolution of clinical symptoms and pseudocyst on follow-up imaging at 6-10 weeks. Complications were assessed at 24-hrs and day 30. Results: Thirty patients were randomized to undergo pseudocyst drainage by EUS (n = 15) or EGD (n = 15). Mean age of patients was 47 yrs and 62% (18/29) were men. Except for gender, there was no difference in patient/clinical characteristics between both cohorts. Of 15 patients randomized to EUS, drainage was not undertaken in 1 due to diagnosis of biliary adenoma at EUS and was excluded (post-randomization) from analysis. While all other patients (n = 14) randomized to EUS underwent successful drainage (100%), the procedure was technically successful in only 5 of 15 (33%) randomized to EGD (p < 0.001). Reasons for technical failures in 10 patients randomized to EGD were: absence of luminal compression in 9 and severe bleeding following attempted puncture of the pseudocyst in 1. All 10 patients who failed drainage at EGD underwent successful drainage on cross-over to EUS. There was no significant difference in rates of treatment success between EUS and EGD following stenting either by intention to treat analysis (100% vs. 87%; p = 0.48) or as-treated analysis (93% vs. 93%; p = 1.00). While no complications were encountered in patients who underwent drainage by EUS (0/24), major procedure-related bleeding was encountered in 2 of 6 patients (33.3%, 95% CI: 4.3 − 77.7) in whom drainage by EGD was attempted that resulted in the death of 1 patient (1/5 with technical success) and necessitated blood transfusion in another (1/10 with technical failure). Technical success was significantly higher for EUS than EGD even after adjusting for luminal compression and gender (adjusted exact OR = 39.4; p = 0.001). Conclusions: When available, EUS should be considered as the first-line treatment modality for endoscopic drainage of pancreatic pseudocysts given the high technical success rate and superior safety profile of the technology.