C. HassanC. Hassan

La capsula endoscopicaLa capsula endoscopica

((CCECCE))

Why Why

do we need do we need

a a new screening test? screening test?

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

Can colon capsuleCan colon capsule

meetmeet

people people expectationsexpectations??

New PillCam Design 2-sided video cameras; 4 images per second, 2 fps

per camera Dimensions:

• Diameter: Same as PillCam SB• Length: 5mm longer than PCSB

Ø11

mm

31 mm

PillCamPillCam®® COLON Capsule COLON Capsule

No tube = No painNo tube = No pain No complicationNo complication Home-deliveredHome-delivered

No embarassmentNo embarassment No inconvenienceNo inconvenience Per os Per os

administeredadministered

Advantages of colon capsule

TOLERABLE (bowel preparation)TOLERABLE (bowel preparation)

TECHNICALLY SUCCESSFULTECHNICALLY SUCCESSFUL

ACCURATE FOR ADVANCED ACCURATE FOR ADVANCED

NEOPLASIANEOPLASIA

EFFICIENT IN INDICATING EFFICIENT IN INDICATING

ENDOSCOPYENDOSCOPY

Ideal colon capsule

IsIs

bowel preparation bowel preparation

for CCE for CCE

tolerable and effectivetolerable and effective ? ?

Day before examination

Day ofexamination

5-6 Liters !

PEG 3 LITERSTo clean the colon

PEG 1 LITERTo clean the colonSubmarine view

1-2 NaP booster+1-2 LITERTo propel the capsule

18-2100

6-700

10-1400

800

Bowel preparation

7.4500 Domperidone 20 mg

Bowel preparation

Good-excellent

Fair-poor

MEDIAN (range) of the mean values of 8 studies

Is CCE Is CCE

technicallytechnically successful? successful?

~2.4 hours (+2 h)

Technical failure

XX

No CCE colonoscopy

CCE incompletecolonoscopy

~2.2 hours(+1.5 h)

What isWhat is

CCE CCE accuracyaccuracy

for polyp?for polyp?

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 

CCE: POLYP ANY SIZE

71% (61-76%)I2: 12.9%

Sensitivity

75% (66-83%)I2: 53%

Specificity

CCE: >6 mm polyp or >3 polyp

68% (56-79%)I2: 60%

Sensitivity

82% (77-85%)I2: 9%

Specificity

Sensitivity for >6 mm polyps

Level bowel prep

Good-excellent

Poor-fair

What isWhat is

CCE CCE sensitivitysensitivity

for cancer?for cancer?

CCE: CANCER

 

Van Gossum et al. (2009)

Sieg et al. (2009)

Spada et al. (2009)

 Total

CancerCCE

19

1

1

21

CancerCapsule

14

1

1

16

Pooled sensitivity (95% CI)

76%(58-94%)

Colonoscopy

Additional Information on Misses of Adenocarcinoma by PillCam

Site Referral AdenoK by OCCapsule finding

PillCam

cleansing

Comments

Italy Hematochezia 40 mm, left< 6mm, right

< 6mm, sigm. Fair “Inadequate preparation precluding the visualization of colonic mucosa”

ItalyHematochezia

> 10 mm, left No finding Poor “Inadequate preparation precluding the visualization of colonic mucosa”

ItalyHematochezia

> 10 mm, left No finding Poor No comments

Spain CRC 40 mm, rectum2 x < 6mm, sigm

GoodK 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

Lieberman DA, NEJM 2009

76% 68%

=

Sensitivity Cancer

Advanced Adenoma

How efficient isHow efficient is

colon capsule in selecting subjects for colon capsule in selecting subjects for

colonoscopy colonoscopy

in ain a screening setting? screening setting?

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.

No threshold

COLON CAPSULE EFFICIENCYCOLON CAPSULE EFFICIENCY

Post-capsuleOC referral rate

PPV for polyp

>6 mm

What are

the main risks of bias

in the available studies?

DistortionDistortion bias (enriched-disease bias (enriched-disease

pop.)pop.)

Withdrawal Withdrawal bias (no consecutive bias (no consecutive

enrolm.)enrolm.)

ClassificationClassification bias bias

No unblinding at colonoscopyNo unblinding at colonoscopy

Polyp-matching algorithm Polyp-matching algorithm

imperfectimperfect

RISK OF BIAS

ConclusionsConclusions

CCE may potentially meet people CCE may potentially meet people expectationsexpectations

Technology is expected to reach a 100% Technology is expected to reach a 100% technical success of CCE, and a very high technical success of CCE, and a very high accuracy in pts. with good-excellent bowel accuracy in pts. with good-excellent bowel preparationpreparation

GI-field need to focus on tolerability and GI-field need to focus on tolerability and efficacy of bowel prepefficacy of bowel prep

ConclusionsConclusions Future research:Future research:

CC1 to CC2CC1 to CC2 Consecutive enrollmentConsecutive enrollment Screening settingScreening setting Unblinding at colonoscopyUnblinding at colonoscopy Sensitivity for cancerSensitivity for cancer Specificity for polypsSpecificity for polyps Bowel preparationBowel preparation AcceptabilityAcceptability Endoscopist capacityEndoscopist capacity