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P442 Outcome of early surgery versus aggresive medical therapy in patients with newly diagnosed limited inflammatory/obstructive (A2/3L1B1/2) terminal Ileitis: A two-year, prospective, single-center, pilot study

G. Mantzaris*1, K. Papamichael1, I. Papakonstantinou2, D. Magganas3, I. Kalogeropoulos4, E. Archavlis1, A. Christidou1, H. Vienna1, N. Kyriakos1, X. Tzannetakou1, I. Internos1, S. Anastasiadis1, P. Karatzas1, L. Varytimiadis1

1Evangelismos Hospital, Gastroenterology Department, Athens, Greece, 2Aretaeion Hospital, B' Department of Surgery, Athens, Greece, 3Evangelismos Hospital, A' Department Of Surgery, Athens, Greece, 4Evangelismos Hospital, Radiology Department, Athens, Greece

Background

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 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 A2/3L1B1/2).

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 < or =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 case-to-case basis considering patient's age, life expectations, disease activity, relative degree of obstruction vs inflammation, and treatment morbidity. Large prospective trials are needed to evaluate longer-term outcomes.