1. 1 Literature Review Peter R. McNally, DO, FACP, FACG University Colorado School of Medicine Center for Human Simulation Aurora, Colorado 80045

2. 2 Beltran PV, Nos P, Bastida G, Beltran, B, Arguello L, Aguas M, Rubin A, Pertejo V, Sala T. Evaluation of postsurgical recurrence in Crohns disease: a new indication for capsule endoscopy? Gastrointest Endoscopy. 2007;66:533-40 Valencia, Spain

3. 3Introduction Postoperative relapse of Crohns disease is common. 1 Postoperative relapse of Crohns disease is common. 1 – Neoileum relapse is 73 & 85% and symptomatic relapse is 20 & 34% at 1 and 3 yr Post Op. 1 Prophylactic post operative immunosuppressant therapy is recommended for the High Risk to Relapse Group. 2 Prophylactic post operative immunosuppressant therapy is recommended for the High Risk to Relapse Group. 2 – Fistulizing Disease – Ileocolonic location – Smoker Post Operative endoscopic surveillance at 6-12 mo is recommended for the Average Risk to Relapse Group. 3 Post Operative endoscopic surveillance at 6-12 mo is recommended for the Average Risk to Relapse Group. 3 Rutgeert P, et al. Gastroenterol. 1990;99:956-63. Rutgeert P. Gut. 2002;51:152-3. 1. Rutgeert P, et al. Gastroenterol. 1990;99:956-63. 2. Rutgeert P. Gut. 2002;51:152-3. 3. DHaens G, et al. Inflamm Bowel Dis. 1999;5:295-303.

4. 4 Introduction Wireless capsule endoscopy (CE) has recently been shown to be more accurate than Ileocolonoscopy in detecting small bowel activity among patients with Crohns. 4 Wireless capsule endoscopy (CE) has recently been shown to be more accurate than Ileocolonoscopy in detecting small bowel activity among patients with Crohns. 4 Gold Standard for the monitoring Post Op Crohns Disease for relapse has been Ileocolonoscopy. Gold Standard for the monitoring Post Op Crohns Disease for relapse has been Ileocolonoscopy. This study examined safety and utility of CE to monitor for post operative relapse when compared to the Gold Standard. This study examined safety and utility of CE to monitor for post operative relapse when compared to the Gold Standard. 4.Triester S, Leighton JA, Leontiadis GI, et al. Am J Gastroenterol 2006;101:954-64 Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40

5. 5 Aim To test the safety and accuracy of CE to detect post operative relapse of Crohns in the neoileum. To test the safety and accuracy of CE to detect post operative relapse of Crohns in the neoileum. Compare the safety, patient tolerance, accuracy of CE to Ileocolonoscopy to detect relapse among clinically asymptomatic post operative Crohns patients. Compare the safety, patient tolerance, accuracy of CE to Ileocolonoscopy to detect relapse among clinically asymptomatic post operative Crohns patients. Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40

6. 6 Study Design: Prospectively enrolled Crohns patients after ileocolonic anastomosis between Oct 2003 and Oct 2005. Prospectively enrolled Crohns patients after ileocolonic anastomosis between Oct 2003 and Oct 2005. Demographics Demographics – N=24 (13 and 11 ) – All Asymptomatic – None on prophylactic treatment to prevent relapse Exclusion Criteria: Exclusion Criteria: – History Dysphagia – Pregnancy – Lactation – Life-threatening conditions – Nonsteroidal anti-inflammatory drug intake Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40

7. 7 Study Evaluations Study Evaluations (all within 2 wk): Study Evaluations (all within 2 wk): – M2A Patency Capsule (Given Imaging Ltd, Yoqneam,Isreal), – Ileocolonoscopy (CF-VL, Olympus, Tokyo, Japan) – CE (M2A Given Imaging Ltd, Yoqneam,Isreal). Rutgeerts Index 1 > 2 used to defined recurrence Rutgeerts Index 1 > 2 used to defined recurrence 0:no changes 0:no changes 1:< 5 aphathous lesions 1:< 5 aphathous lesions 2:> 5 aphathous lesions, with nl skip mucosa 2:> 5 aphathous lesions, with nl skip mucosa 3:diffuse aphathous ileitis 3:diffuse aphathous ileitis 4:diffuse inflammation: ulcers, nodules &/or narrowing 4:diffuse inflammation: ulcers, nodules &/or narrowing Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40

8. 8 Materials and Methods Evaluations: M2A Patency Capsule Evaluations: M2A Patency Capsule Capsule passage: Patient confirmation or X-ray location in colon or patency scanner Capsule passage: Patient confirmation or X-ray location in colon or patency scanner Transit normal < 40hrs Transit normal < 40hrs Patency Capsule Patency Capsule Scanner Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40

9. 9 Materials and Methods Examination Neoileum Examination Neoileum – Ileocolonoscopy (CF- VL, Olympus, Tokyo, Japan) – CE (M2A Given Imaging Ltd, Yoqneam,Isreal). Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40

10. 10 Evaluations: Ileocolonoscopy Evaluations: Ileocolonoscopy – Fosfosoda (Casen Fleet) bowel prep 45 ml X2 – Conscious Sedation: medazolam (2-3 mg) or Fentanyl (50 microgram) – Neoileum examined as far as possible (10-30 cm) – Findings Graded by Rutgeerts Index 1 Evaluations: Patient Comfort Survey Evaluations: Patient Comfort Survey – Completed after CE and Ileocolonoscopy Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40

11. 11 CE Showing Ileal Ulceration Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40

12. 12 Patient Characteristics: Gender:11/13 (M/F) Age: 38 (18-71 yr) Clinical Characteristics Smokers50% time from surgery254 days time from surgery254 days Perianal Disease88% Surgery Surgery Ileo-Ascending anastamosis67% Ileo-Transverse anastamosis33% Length resection (cm)34 (13-60) Disease Activity Markers Erythrocyte sedimentation19 (7-24) C-reactive protein (0-8mg/L)1.2 (0-6) Crohns Disease Activity Index56 (23-168) Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40

13. 13 Results: CE vs.. Ileocolonoscopy N =24 ProcedureFailure Crohn's (+) Patency M2A 22/24 2/24 ( 8.3%) Non passage CE21/22 1/22 ( 4.5%) Fail to transmit 15/22 (62%) 13 proximal Ileocolon- oscopy 24/24 3/24 (12%) Fail to intubate 6/21 (25%) Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40

14. 14 Results: Patient Comfort All patients preferred CE to endoscopy All patients preferred CE to endoscopy Bowel prep for endoscopy disrupted daily activity more than liquid diet for CE (83% vs. 20%) Bowel prep for endoscopy disrupted daily activity more than liquid diet for CE (83% vs. 20%) 50% of the pts considered the endoscopy uncomfortable 50% of the pts considered the endoscopy uncomfortable 8/24 (33%) pts required additional conscious sedation during the neoileal exploration 8/24 (33%) pts required additional conscious sedation during the neoileal exploration Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40

15. 15 Reviewer Comments Beltran, et al, have clearly shown the following: 1. 2/24 (8.3%) non passage of patency capsule suggests the need to evaluate luminal patency before CE in asymptomatic post op Crohns 2. CE is superior to endoscopy (62% vs. 25%) in the detection of active post operative Crohns disease. 3. CE is preferred by pts over endoscopy for evaluation of post operative Crohns Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40

16. 16 Reviewer Comments Beltran, et al, do not answer the question: 1. Does detection of post operative Crohns disease by either method (endoscopy or CE) make a difference in managing this disease? 2. However, the authors will certainly have an answer in the future. Those patients in this study with Rutgeerts score > 2 were offered therapeutic modification with 2.5 mg/kg/day azathioprine. Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40