Hassan. La capsula endoscopica. ASMaD 2010

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Hassan. La capsula endoscopica. ASMaD 2010

  1. 1. C. Hassan La capsula endoscopica ( CCE )
  2. 2. <ul><li>Why </li></ul><ul><li>do we need </li></ul><ul><li>a new screening test? </li></ul>
  3. 3. Winawer SJ, Zauber AG, Ho MN, et al. N Engl J Med 1993;329:1977-81 . Segnan N, Senore C, Andreoni B, et al. Gastroenterology 2007;132:2304-12. Lisi D, Hassan C, Crespi M. Dig Liver Dis. 2009; PMID: 19747888 Efficacy Adherence Colonoscopy screening
  4. 4. <ul><li>Can colon capsule </li></ul><ul><li>meet </li></ul><ul><li>people expectations ? </li></ul>
  5. 5. PillCam ® COLON Capsule <ul><li>New PillCam Design </li></ul><ul><li>2-sided video cameras; 4 images per second, 2 fps per camera </li></ul><ul><li>Dimensions: </li></ul><ul><ul><li>Diameter: Same as PillCam SB </li></ul></ul><ul><ul><li>Length: 5mm longer than PCSB </li></ul></ul>Ø11 mm 31 mm
  6. 6. <ul><li>No tube = No pain </li></ul><ul><li>No complication </li></ul><ul><li>Home-delivered </li></ul><ul><li>No embarassment </li></ul><ul><li>No inconvenience </li></ul><ul><li>Per os administered </li></ul>Advantages of colon capsule
  7. 8. <ul><li>TOLERABLE (bowel preparation) </li></ul><ul><li>TECHNICALLY SUCCESSFUL </li></ul><ul><li>ACCURATE FOR ADVANCED NEOPLASIA </li></ul><ul><li>EFFICIENT IN INDICATING ENDOSCOPY </li></ul>Ideal colon capsule
  8. 9. <ul><li>Is </li></ul><ul><li>bowel preparation </li></ul><ul><li>for CCE </li></ul><ul><li>tolerable and effective ? </li></ul>
  9. 10. Day before examination Day of examination 5-6 Liters ! PEG 3 LITERS <ul><li>To clean the colon </li></ul>PEG 1 LITER <ul><li>To clean the colon </li></ul><ul><li>Submarine view </li></ul>1-2 NaP booster+1-2 LITER <ul><li>To propel the capsule </li></ul>18-21 00 6-7 00 10-14 00 8 00 Bowel preparation 7.45 00 Domperidone 20 mg
  10. 11. Bowel preparation Good-excellent Fair-poor MEDIAN (range) of the mean values of 8 studies
  11. 12. <ul><li>Is CCE </li></ul><ul><li>technically successful? </li></ul>
  12. 13. ~ 2.4 hours ( + 2 h) Technical failure X X No CCE colonoscopy CCE incomplete colonoscopy ~ 2.2 hours ( + 1.5 h)
  13. 14. <ul><li>What is </li></ul><ul><li>CCE accuracy </li></ul><ul><li>for polyp? </li></ul>
  14. 15. SYSTEMATIC REVIEW: 2006-2009 Significant polyp ( > 6 mm/>3) 16 13 87 0 64 6 13 22 199   Full/ abstr. Eliakim et al. (2006) full Schoofs et al. (2006) full Van Gossum et al. (2009) full Sieg et al. (2009) full Gay et al. (2009) full Pilz et al. (2008) Abstr. Spada et al. (2009) Abstr. Sacher-Huvelin et al. (2009) Abstr.   Total   Patients included 84 36 320 36 126 59 40 105 806 Polyp any size 36 25 212 11 67 28 20 - 399 Multi-centre Yes No Yes No No No No Yes l  
  15. 16. CCE: POLYP ANY SIZE 71% (61-76%) I 2 : 12.9% Sensitivity 75% (66-83%) I 2 : 53% Specificity
  16. 17. CCE: > 6 mm polyp or > 3 polyp 68% (56-79%) I 2 : 60% Sensitivity 82% (77-85%) I 2 : 9% Specificity
  17. 18. Sensitivity for > 6 mm polyps Level bowel prep Good-excellent Poor-fair
  18. 19. <ul><li>What is </li></ul><ul><li>CCE sensitivity </li></ul><ul><li>for cancer? </li></ul>
  19. 20. CCE: CANCER Pooled sensitivity (95% CI) 76% (58-94%) Colonoscopy   Van Gossum et al. (2009) Sieg et al. (2009) Spada et al. (2009)   Total Cancer CCE 19 1 1 21 Cancer Capsule 14 1 1 16
  20. 21. Additional Information on Misses of Adenocarcinoma by PillCam Site Referral AdenoK by OC Capsule finding PillCam cleansing Comments Italy Hematochezia 40 mm, left < 6mm, right < 6mm, sigm. Fair “ Inadequate preparation precluding the visualization of colonic mucosa” Italy Hematochezia > 10 mm, left No finding Poor “ Inadequate preparation precluding the visualization of colonic mucosa” Italy Hematochezia > 10 mm, left No finding Poor No comments Spain CRC 40 mm, rectum 2 x < 6mm, sigm Good K was located in rectum. Capsule stopped working at the sigmoid (at 07.52h) Lyon CRC Pedunculated 8-9 mm, sigm. 6 x < 6mm: 1-right 2-left 2-sigmoid 1-rectum Good No comments
  21. 22. Lieberman DA, NEJM 2009 76% 68% = Sensitivity Cancer Advanced Adenoma
  22. 23. <ul><li>How efficient is </li></ul><ul><li>colon capsule in selecting subjects for colonoscopy </li></ul><ul><li>in a screening setting? </li></ul>
  23. 24. Lieberman D, Moravec M, Holub J, et al. Gastroenterology 2008;135:1100-5. Rex DK, Overhiser AJ, Chen SC, et al. Am J Gastroenterol 2009;104:149-53. Pickhardt PJ, Choi JR, Hwang I, et al. N Engl J Med 2003; 349: 2191-2200. Kim DH, Pickhardt PJ, Taylor AJ, et al. N Engl J Med 2007;357:1403-12.
  24. 25. COLON CAPSULE EFFICIENCY No threshold Post-capsule OC referral rate PPV for polyp > 6 mm
  25. 26. What are the main risks of bias in the available studies?
  26. 27. <ul><li>Distortion bias (enriched-disease pop.) </li></ul><ul><li>Withdrawal bias (no consecutive enrolm.) </li></ul><ul><li>Classification bias </li></ul><ul><ul><li>No unblinding at colonoscopy </li></ul></ul><ul><ul><li>Polyp-matching algorithm imperfect </li></ul></ul>RISK OF BIAS
  27. 28. Conclusions <ul><li>CCE may potentially meet people expectations </li></ul><ul><li>Technology is expected to reach a 100% technical success of CCE, and a very high accuracy in pts. with good-excellent bowel preparation </li></ul><ul><li>GI-field need to focus on tolerability and efficacy of bowel prep </li></ul>
  28. 30. Conclusions <ul><li>Future research: </li></ul><ul><ul><ul><ul><li>CC1 to CC2 </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Consecutive enrollment </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Screening setting </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Unblinding at colonoscopy </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Sensitivity for cancer </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Specificity for polyps </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Bowel preparation </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Acceptability </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Endoscopist capacity </li></ul></ul></ul></ul>

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