Ethanol Pancreatic Injection of Cysts (EPIC): Preliminary Results of a Prospective Multicenter, Randomized, Double Blinded Study

Abstract

Background/Aims: Pilot data from EUS-guided ethanol lavage (EUS-EL) of pancreatic cystic lesions (PCLs) suggested that cyst resolution and epithelial ablation may be achieved as demonstrated by imaging and surgical pathology. Aim: To validate these data in a multicenter, randomized double-blinded study. Hypothesis: EUS-EL with 80% ethanol will decrease the size and cyst fluid CEA of PCLs by ≥25%, more often than saline lavage (EUS-SL) at 3 months following treatment. Methods: Patients referred for EUS of a 10-50 mm PCL with 0-4 septations were randomized to 5 minute EUS-EL #1 or EUS-SL #1. The patient and physician were blinded to the identity of the lavage agent (ethanol or saline). Cyst fluid was evaluated for CEA, amylase and cytology. Subjects were contacted twice within the next week. Those managed medically returned at 3 months for re-measuring of cyst size, cyst aspiration and fluid analysis and 5 minute EUS-EL #2. Follow-up CT was repeated every 3-6 months. Surgery was allowed at any time during the study. The clinical diagnosis of PCLs was made by a combination of imaging morphology, cytology, cyst fluid CEA and/or surgery. Results: From 10/04-9/06, 51 patients were consented, 12 were excluded prior to initial lavage and 39 (26 F; mean age:69 yrs) with suspected mucinous (32) or nonmucinous (4) pancreatic cystic tumors and pseudocysts (3) were randomized to EUS-EL (23) or EUS-SL (16). Cyst size: median 19 mm (range: 10-40) and location: head/uncinate (17), body (15) or tail (7). The frequency of a decrease in cyst size and cyst fluid CEA of ≥25% at 3 months after randomization and complications with treatment are shown in Table 1. EUS-EL #2 was completed in 18 (78%) and 12 (75%) initially randomized to EUS-EL or EUS-SL, respectively. Complications from EUS-EL #2: abdominal pain (3), including acute pancreatitis in one. Surgical pathology in 2 who underwent PCL resection after EUS-EL: 1) benign 35 mm IPMN-Br in the tail with histology showing 50-75% epithelial ablation and; 2) benign 22 mm MCN in the uncinate with histology showing 100% epithelial ablation. Imaging following EUS-EL #2 demonstrated complete resolution of 5 suspected mucinous tumors and 1 pseudocyst. Conclusion: EUS-EL decreased pancreatic cyst size with few complications and may result in histopathologic epithelial ablation. In a subset (22%), complete resolution was achieved. Tabled 1Table 1 EUS-EL #1 (n = 23) EUS-SL #1 (n = 16) p-value Cyst diameter ↓ ≥25% 61% 17% 0.025 Cyst fluid CEA ↓ ≥25% 38% 40% 1.0 Abdominal pain 22% 19% 1.0 Pancreatitis 4% 0% 1.0 Cyst resolution by follow-up imaging after EUS-EL #2 22% 8% 0.6 Open table in a new tab