Tu1239 Outcome of Early Surgery Versus Aggressive Medical Therapy in Patients With Newly Diagnosed Limited Inflammatory/Obstructive (A2/3L1B1/2) Terminal Ileitis: A Two-Year, Prospective, Single-Center, Pilot Study

Abstract

Background: Data are scarce regarding the outcome of ‘curative' early surgery (ES) versus ‘aggressive medical therapy' [AMT, azathioprine (AZA) and anti-TNF biologics] for limited mixed inflammatory-obstructive Crohn's terminal ileitis (LMI/OTI). EST achieves removal of the affected segment and induces prolonged remission reserving immunosuppressives for patients at high-risk for post-operative recurrence. AMT can induce and maintain remission of CD but may be associated with serious adverse events and cannot guarantee long-term avoidance of surgery. Aim: To assess prospectively in a single-center pilot study the 2-year outcome of EST vs AMT in consecutive patients with LMI/OTI (phenotype A2/3L1Β1/2). Methods: Eligible were patients with newly diagnosed active (CDAI>180) LMI/OTI CD (despite treatment with 9mg/d budesonide for 6-8 weeks) and at high-risk for post-operative recurrence. LMI/OTI was defined as the combination of: a) raised inflammatory indices (leukocytes, platelets, CRP), b) involvement of ≤ 25cm terminal ileum, characterized by a narrow lumen, ulcerated but slightly distensible bowel wall with pre-stenotic dilatation although not purely stricturing disease at enteroclysis or MRI enterography, and c) inability to pass the colonoscope to the proximal unaffected ileum. After a thorough discussion, enrolled patients opted for AMT or EST (laparoscopic or open). EST patients received AZA (2.5mg/kg) for post-operative prophylaxis starting 14 days after surgery. AMT patients received standard doses of AZA and anti-TNF agents. Patients were followed for 2 years by physical examination and laboratory tests at bimonthly visits. Endoscopy was performed at 6, 12, and 24 months. Primary end-points were endoscopic remission (Rutgeerts score ≤1) for EST and avoidance of surgery for AMT. Results: Between 2007 and 2011, 17 patients [7M:10F, mean age 24(18-67) years, 12 smokers] consented to undergo EST and 17 patients [8M:9F, age 26(17-68) years, 13 smokers] received AMT. 2 years after EST, 3/17 (18%) patients had endoscopic recurrence and switched to biologics; 82% patients were in endoscopic remission. On AMT, 10/17 (59%) patients underwent surgery for complications (bowel obstruction and/or abscess, n=5), lack of efficacy (n=3) or adverse events to therapy (n=2); seven patients were in clinical remission (3 in deep remission). Conclusion: In this pilot study in consecutive CD patients selected by the A2/3L1B1/2 phenotype, EST appears to offer a better 2-year outcome than AMT. However, decisions should be taken on a caseto-case basis considering patient's age, life expectations, disease activity, relative degree of