Capsule Endoscopy Emerging Topics

Manuel Martinez, MDDirector of EndoscopyVA Brooklyn Campus

Goals• Review the current hardware / software and WCE

technology available in the US.• Review WCE indications, contraindications and clinical

utility in the field of gastroenterology.• Training future gastroenterologist and standardization

of WCE examination and interpretation• Touch upon emerging WCE technologies.

Wireless Capsule Endoscopy

(WCE) • Approved by FDA in 2001 to visualize the GI tract.

• There are 3 companies manufacturing SB WCE systems that are approved by the FDA; Olympus America Inc., Given Imaging, Israel and IntroMedic Company Ltd.; Korea

• All capsule endoscopes are disposable.

WCE Systems• All 3 capsules (to evaluate the small

bowel) available in the market have similar components –image capture system, CMOS or High resolution CCD, compact lens white-LED illuminating source and internal battery.

WCE Mode of Data Transmission

• Pillcam and EndoCapsule have ultra-high frequency band radio telemetry.

• MiroCam uses human body communication where by the capsule generates an electrical field and transmits data conducted via human tissue.

Software Rapid Reader 6.5WS-1 EndoCapsuleMicro View Express

OMOM CapsuleNewer capsule on the market2 images / sec140 degree viewing angle

CapsoCam SV1

EsoCE

Given has only WCE system that has a capsule specifically designed for esophagus. Battery life 20 min, front and back camera imaging5 min ingestion protocol= In Left Lateral position capsule ingestion with sips of H2O --- 2 min supine 2 min 300 and 1 min 600 followed by 15 min upright

EsoCapsule Proposed Indications

• Barrett’s • Esophagitis• Screening / Surveillance of Esophageal

VaricesBut- Role in clinical practice remains to be established

Small bowel WCE Indications

• Obscure GI Bleed : Occult / Overt• Suspected Crohn’s Disease• Surveillance in Polyposis Syndrome• Suspected Small Bowel Tumor• Refractory Malabsorption Syndrome (CD)• Approved for children ≤ 2 old

Contraindications• GI Obstruction• Swallowing disorder (may need

endoscopic deployment)• Pregnancy• MRI *

• “Cardiac devices i.e. AICD / Pacemakers “

Patency Capsule

Parylene outer coat with lactose and barium core. RFID tag imbedded within core

Zencker’s Diverticulum

MRI Cloverleaf Effect

Cardiac Devices: Is it Safe? • Capsule endoscopy -- a

radiofrequency transmission-based device – is contraindicated, according to US Food and Drug Administration (FDA) device labeling

Devices Interrogated In Vitro

• leading manufacturers of pacemakers and ICDs (Boston Scientific, St. Jude Medical, Medtronics, and Thoratec), and the 4 major cellular phone carriers (both 3G and 4G).

WCE Compatibility with Cardiac Devices

• Pacemaker or ICD with endoscopy capsule;

• ICD with LVAD and endoscopy capsule

• ICD with capsule endoscopy and phone, pager, or laptop computer; and

• ICD with a shock and endoscopy capsule.

Results• No Interference in all interrogated devices.• Although WCE is contraindicated by the FDA

and by product instructions, there is sufficient observational as well as in-vitro data that show it is safe to use in complex cardiac patients. Fleming PS, Lossen V, Brown J, et al. Exploring the interface between

wireless cardiac devices, capsule endoscopy, and nonmedical devices. Ann

Gastroenterol Hepatol. 2013;4:1-5.

Obscure GI Bleed (OGIB)

WCE and OGIB• Detection of potential lesions 35% to 77% • Variables associated with increased

detection rates 1) perform within 1 week bleed 2) inpt status 3) overt bleed requiring transfusion 4) advanced age 5) on warfarin 6) liver comorbidity Lecleire et al. Endoscopy 2012;44 Esaki et al. Dig Dis Sci 2010;55

OGIB

• One Study showed diagnostic yield was 92% for overt GIB and for FeDef Anemia yield = 44%. Lepilieur et al, Clin Gastro Hep 2012

• The earlier during hospitalization, the likelier the capsule study would detect an active bleed.

• CE reduced hospital stay by 40%• If CE was performed more than 3 days of admission, the

chance of identifying source was equal to an outpt study. Singh et al, Gastrointest Endosc 2013

Comparing Capsule Brands in OGIB

• 3 Prospective randomized trials comparing Pillcam, EndoCapsule and MiroCam for w/u OGIB.

• There is comparable diagnostic yield and moderate inter-observer agreement between the 3 products currently available.

OGIB Trials• Retrospective Trial of 75 patients with OGIB

underwent WCE and found to have relevant lesions in 67% of the cases.

• Of these, 50% had confirmed lesion that were treated.

• 31 patients were followed up and all but one had no further bleeding after 6 month.

Redondo-Cerezo E, et al, Dig Dis Sci 2007:52:1376-81

WCE in OGIB Trials• Retrospect-Trial demonstrated WCE changes

management in 37% and 42% of patients with Obscure-Occult and Obscure-Overt bleeding respectively. Barnett, CB, et al, Gastro Hep (NY) 2007,3

• Prospect-Trial of 78 pts with OGIB followed 6 months, 26% of pts with lesions detected had rebleed compared to 4% who had negative findings. Iwamoto , J et al Hepatologastroenterology 2011, 58

WCE vs Angiography• 25 pts with overt and occult OGIB

both underwent CT angio and Standard angio followed by WCE. Diagnositic yield of WCE was superior to CT angio, but similar to Standard angio.

WCE vs Enteroscopy Trials on OGIB

• WCE vs Intra-Op Enteroscopy – WCE identified source in 74.5% compared to 72% for Intra-Op.

• WCE vs Push Enteroscopy- WCE was superior

50% vs 24% respectively.

WCE vs Enteroscopy Cont’d

• Overall Diagnostic Yield of WCE vs DBE are similar

• DBE was superior in patient with Roux-en-Y anatomy and diverticula

• WCE was superior in areas inaccessible to DBE.

SB Crohn’s

Crohn’s Disease• Overall WCE is useful for the evaluation of the small bowel

in patients that remain without a diagnosis.• Cohort of 27 pts with suspected Crohn’s followed for 21

months , WCE had s / s 93% and 84%.• Cohort of 39 pts with known Crohn’s s / s 89 % and 100%• Retrospective study of 86 asymptomatic pts with known

Crohn’s dz demonstrated active dz in 78% and lead to change in management in 74% of patients.

• WCE vs. Radiological imaging in Crohn’s dz ; results are disperate.

• Prospective blinded trial of 41 pts w/ known or supected Crohn’s -> No sig diff between WCE, CTE and SBS in detecting active disease sensitivity 83%, 82%, 65% specificity 53%, 89%, 94% respectively

However

• Blinded study of 35 pts w/ susp Crohn’s; a dx was made in 72% WCE, 23% SBE, 20% CTE

• Prospective blinded study of 31 pts with known Crohn’s ; WCE was superior to CT enteroclysis for detecting TI dz 71% vs 26% p < 0.01 and for proximal small bowel 46% vs 13% p< 0.001

WCE vs Imaging in Crohn’s

• Large Prospective blinded study - 93 pts with new dx Crohn’s dz on ileal colonoscopy.

• WCE vs MRE vs CTE sens 100%, 81%, 75% and spec 91%, 86%, 85% respectively

Limitations• WCE is limited in dx Crohn’s via validated

capsule criteria ( Lewis score / CAI being validated) and no possibility for tissue diagnosis (Particularly in setting of NSAID related cases).

• 14% of otherwise healthy individuals without hx of NSAID use or hx of Crohn’s can have mucosal breaks.

SB Polyps / Tumors

Small Bowel Polyps & Tumors

• WCE is safe in Polyposis Syndrome, Peutz-Jeghers Syndrome and Post-Surgical Anatomy.

• FAP--- WCE can detect polyps 24% - 57%; but not able to evaluate the ampulla adequately.

• Peutz-Jegher’s--- Polyps detected 27% WCE vs 12.5% with SBFT; WCE is more comfortable and preferred by patient.

Trials • FAP and Peutz-Jegher’s--- camparing

WCE vs MRE both equal in detecting Polyps ≥ 15mm

• WCE superior in detecting Polyps ≤ 5mm.

• MRE provides extraluminal info and location of polyp/s.

Flexible Spectral Imaging Color Enhencment

FICE Flexible Spectral Imaging Color Enhencement

WCE-SB Tumor detection rate evaluating for other indications

Pooled analysis of 24 prospective WCE trials for bleeding and non-bleeding indications, WCE was superior to SBFT and CTE in detecting small bowel tumors. But, miss rate is 14%

WCE vs DBE in Polyposis Syndrome

• Small Study 9 pts showed that DBE was superior in identifying small bowel polyps vs WCE.

NB• Retrospective Studies 7 pts -> Neg WCE had tumors

found on other modalities. WCE vs CTE for SB tumors, CTE was superior to WCE 94% vs 35% respectively

• 183 pt evaluated for GIB, 18 pt had mass by DBE of these, 15 also had WCE studies. Only 5 of the WCE studies detected the mass lesion. Ross et al Dig Dis Sci 2008;53

• NB-WCE has role in evaluation for SB tumors but a negative exam does not rule-out mass.

CD

WCE & Celiac Disease• 6 studies consisting of 166 pts w/ bx proven CD: WCE s / s

89% / 95% with 95% CI and good to excellent IOV.• One study demonstrated mucosal Δ c/w CD in 66% of pts w/

known CD. WCE may have possible advantage to EGD / SBE.• One Prospective study 47 pts w/ known CD after extensive w/u

for refractory symptoms-> WCE demonstrated findings in 87% of cases and unexpected findings in 49% (i.e. neoplasm, ulceration, stricture). Suggesting WCE has additional role in difficult cases of CD. Rokkas, et al E J Gastro Hep 2012;24 Rondonotti et al, 2007:102 Krauss et al Gastro Endo Clin N AM 2006:16

WCE –GERD / BE• MCT of 106 pts with GERD evaluated by

EsoCE and EGD, EsoCE had s / s 92% / 95% respectively for detecting lesions.

• Meta-analysis of 9 studies 618 pooled pts s / s 77% / 86% for the dx of BE. Bhardwaj et al a AJG2009;104

• EsoCE safe and patient preferred

WCE - Esophagus• 2 Studies evaluating EsoCE and Esophagitis: s / s 50% /

79% making WCE inferior to EGD.• EsoCE and varices meta-analysis s / s 82% / 80% Lu et. al.

WJG 2009:15

• Single blinded study – cirrhotics – WCE accuracy of dx varices / PHG 63%. Chvalitdhamrong et al, Clin Gas Hep2012:10

• Agreement btw WCE & EGD was substantial for presence of varices k= 0.73 and moderate for grading of varices k= 0.53.

Risk Stratification in UGIB

• 83 consecutive pts w/ UGIB were evaluated. 62 pts (75%) were identified with a bleeder on either EGD or WCE. WCE detected 66% and EGD 89% and findings were concordant across both modalities 55%. If duodenal images were achieved, the author concluded WCE correlated well with EGD.

• Although not ready for primetime, more trials needed. Chandran et al Am J Gastro 1994;89

WCE - Colon• 1st generation – per patient sensitivity for polyps

was 71% and significant findings 68%.• 2nd generation – 2 randomized trials- per patient

sensitivity for polyps ≥ 6mm sensitivity was 84% and significant findings 88%.

• polyps ≥ 10 mm 88% an 89% respectively compared with conventional colonoscopy Spada, et.

al., GIE 2011:74 Eliakim, et. al., Endoscopy 2009, 41

Capsule Study Interpretation

• Recommendations are that the examiner have undergone formal GI training and be competent in endoscopy. ASGE guidelines state that readers should have either formal training in CE during fellowships or have completed formal GI or Surgical society-endorsed course with proctoring of 10 capsule readings.

Training in small-bowel capsule endoscopy: assessing and defining competency

• Prospective analysis of GI fellows in CE interpretation.

• Included ASGE guidelines and recommendations 1) completion of hand-on training course, 2)familiarity with hardware/software and 3) 20 supervised reviews of capsule studies after 24months of fellowship training.Rajan,E, et al., GIE 2014

CapCT

Capsule Competency TestFormalized assessment tool

• The CapCT included 3 sections;• 1) series of multiple choice questions i.e.

indications, contraindication, capsule retention rates.

• 2)quiz consisting of 8 cases using 30 second video clips

• 3) full CE cases with procedure reporting

CapCT Study Results

Billing Codes ICD-9

Cost• List Price • Given Imaging

workstation $26,000 capsule $500

• Olympus America workstation $12,150 capsule $ 500

Stowaway

Large Cargo

Thank YouVA Brooklyn Campus

Downstate Medical CenterSuper Colon Team

Given ImagingLiz Rajan, MD Mayo Clinic MC

AndreaSabrinaAdam

Metropolitan Museum of Art

Lamburgini Motor Cars

Zenitram Medical, P.C.