1 literature review peter r. mcnally, do, facp, facg university colorado school of medicine center...

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

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

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Literature ReviewLiterature Review

Peter R. McNally, DO, FACP, FACGPeter R. McNally, DO, FACP, FACG

University Colorado School of MedicineUniversity Colorado School of Medicine

Center for Human SimulationCenter for Human Simulation

Aurora, Colorado 80045Aurora, Colorado 80045

Page 2: 1 Literature Review Peter R. McNally, DO, FACP, FACG University Colorado School of Medicine Center for Human Simulation Aurora, Colorado 80045

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Beltran PV, Nos P, Bastida G, Beltran PV, Nos P, Bastida G, Beltran, B, Arguello L, Aguas M, Beltran, B, Arguello L, Aguas M,

Rubin A, Pertejo V, Sala T. Rubin A, Pertejo V, Sala T.

Evaluation of postsurgical recurrence in Evaluation of postsurgical recurrence in Crohn’s disease: a new indication for Crohn’s disease: a new indication for

capsule endoscopy? Gastrointest capsule endoscopy? Gastrointest Endoscopy. 2007;66:533-40Endoscopy. 2007;66:533-40

Valencia, SpainValencia, Spain

Page 3: 1 Literature Review Peter R. McNally, DO, FACP, FACG University Colorado School of Medicine Center for Human Simulation Aurora, Colorado 80045

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IntroductionIntroduction

• Postoperative relapse of Crohn’s disease is common. Postoperative relapse of Crohn’s disease is common. 11

– Neoileum relapse is 73 & 85% and symptomatic relapse is Neoileum relapse is 73 & 85% and symptomatic relapse is 20 & 34% at 1 and 3 yr Post Op. 20 & 34% at 1 and 3 yr Post Op. 11

• Prophylactic post operative immunosuppressant therapy Prophylactic post operative immunosuppressant therapy is recommended for the High Risk to Relapse Group. is recommended for the High Risk to Relapse Group. 22

– Fistulizing DiseaseFistulizing Disease– Ileocolonic locationIleocolonic location– SmokerSmoker

• Post Operative endoscopic surveillance at 6-12 mo is Post Operative endoscopic surveillance at 6-12 mo is recommended for the Average Risk to Relapse Group.recommended for the Average Risk to Relapse Group.33

1. Rutgeert P, et al. Gastroenterol. 1990;99:956-63. Rutgeert P, et al. Gastroenterol. 1990;99:956-63. 2. Rutgeert P. Gut. Rutgeert P. Gut. 2002;51:152-3. 2002;51:152-3. 3. D’Haens G, et al. Inflamm Bowel Dis. 1999;5:295-303.

Page 4: 1 Literature Review Peter R. McNally, DO, FACP, FACG University Colorado School of Medicine Center for Human Simulation Aurora, Colorado 80045

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IntroductionIntroduction

• Wireless capsule endoscopy (CE) has recently been Wireless capsule endoscopy (CE) has recently been shown to be more accurate than Ileocolonoscopy in shown to be more accurate than Ileocolonoscopy in detecting small bowel activity among patients with detecting small bowel activity among patients with Crohn’s.Crohn’s.44

• ““Gold Standard” for the monitoring Post Op Crohn’s Gold Standard” for the monitoring Post Op Crohn’s Disease for relapse has been Ileocolonoscopy. Disease for relapse has been Ileocolonoscopy.

• This study examined safety and utility of CE to monitor This study examined safety and utility of CE to monitor for post operative relapse when compared to the “Gold for post operative relapse when compared to the “Gold Standard.”Standard.”

4.Triester S, Leighton JA, Leontiadis GI, et al. Am J Gastroenterol 2006;101:954-64

Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40

Page 5: 1 Literature Review Peter R. McNally, DO, FACP, FACG University Colorado School of Medicine Center for Human Simulation Aurora, Colorado 80045

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AimAim

• To test the safety and accuracy of CE to To test the safety and accuracy of CE to detect post operative relapse of Crohn’s in detect post operative relapse of Crohn’s in the neoileum.the neoileum.

• Compare the safety, patient tolerance, Compare the safety, patient tolerance, accuracy of CE to Ileocolonoscopy to accuracy of CE to Ileocolonoscopy to detect relapse among clinically detect relapse among clinically asymptomatic post operative Crohn’s asymptomatic post operative Crohn’s patients.patients.

Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40

Page 6: 1 Literature Review Peter R. McNally, DO, FACP, FACG University Colorado School of Medicine Center for Human Simulation Aurora, Colorado 80045

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Study Design:Study Design:• Prospectively enrolled Crohn’s patients after ileocolonic Prospectively enrolled Crohn’s patients after ileocolonic

anastomosis between Oct 2003 and Oct 2005.anastomosis between Oct 2003 and Oct 2005.• DemographicsDemographics

– N=24 (13 N=24 (13 ♀ and 11 ♂) ♀ and 11 ♂) – All AsymptomaticAll Asymptomatic– None on prophylactic treatment to prevent relapseNone on prophylactic treatment to prevent relapse

• Exclusion Criteria: Exclusion Criteria: – History DysphagiaHistory Dysphagia– PregnancyPregnancy– LactationLactation– Life-threatening conditionsLife-threatening conditions– Nonsteroidal anti-inflammatory drug intakeNonsteroidal anti-inflammatory drug intake

Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40

Page 7: 1 Literature Review Peter R. McNally, DO, FACP, FACG University Colorado School of Medicine Center for Human Simulation Aurora, Colorado 80045

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Study EvaluationsStudy Evaluations• Study Evaluations (all within 2 wk):Study Evaluations (all within 2 wk):

– M2A Patency Capsule (Given Imaging Ltd, M2A Patency Capsule (Given Imaging Ltd, Yoqneam,Isreal),Yoqneam,Isreal),

– Ileocolonoscopy (CF-VL, Olympus, Tokyo, Japan)Ileocolonoscopy (CF-VL, Olympus, Tokyo, Japan)– CE (M2A Given Imaging Ltd, Yoqneam,Isreal).CE (M2A Given Imaging Ltd, Yoqneam,Isreal).

• Rutgeerts’ IndexRutgeerts’ Index11 >> 2 used to defined recurrence 2 used to defined recurrence• 0:0: no changesno changes• 1:1: < 5 aphathous lesions< 5 aphathous lesions• 2:2: > 5 aphathous lesions, with nl “skip” mucosa> 5 aphathous lesions, with nl “skip” mucosa• 3:3: diffuse aphathous ileitisdiffuse aphathous ileitis• 4:4: diffuse inflammation: ulcers, nodules &/or diffuse inflammation: ulcers, nodules &/or

narrowingnarrowing

Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40

Page 8: 1 Literature Review Peter R. McNally, DO, FACP, FACG University Colorado School of Medicine Center for Human Simulation Aurora, Colorado 80045

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Materials and MethodsMaterials and Methods

• Evaluations: M2A Patency Evaluations: M2A Patency Capsule Capsule

• Capsule passage: Patient Capsule passage: Patient confirmation or X-ray confirmation or X-ray location in colon or patency location in colon or patency scannerscanner

• Transit “normal” < 40hrsTransit “normal” < 40hrs

Patency

Capsule

Patency

Capsule

Scanner

Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40

Page 9: 1 Literature Review Peter R. McNally, DO, FACP, FACG University Colorado School of Medicine Center for Human Simulation Aurora, Colorado 80045

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Materials and MethodsMaterials and Methods• Examination NeoileumExamination Neoileum

– Ileocolonoscopy (CF-Ileocolonoscopy (CF-VL, Olympus, Tokyo, VL, Olympus, Tokyo, Japan)Japan)

– CE (M2A Given CE (M2A Given Imaging Ltd, Imaging Ltd, Yoqneam,Isreal).Yoqneam,Isreal).

Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40

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• Evaluations: IleocolonoscopyEvaluations: Ileocolonoscopy– Fosfosoda (Casen Fleet) bowel prep 45 ml X2Fosfosoda (Casen Fleet) bowel prep 45 ml X2– Conscious Sedation: medazolam (2-3 mg) or Conscious Sedation: medazolam (2-3 mg) or

Fentanyl (50 microgram)Fentanyl (50 microgram)– Neoileum examined as far as possible (10-30 cm)Neoileum examined as far as possible (10-30 cm)

– Findings Graded by Findings Graded by Rutgeerts’ IndexRutgeerts’ Index11

• Evaluations: Evaluations: Patient Comfort SurveyPatient Comfort Survey– Completed after CE and Ileocolonoscopy Completed after CE and Ileocolonoscopy

Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40

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CE Showing Ileal Ulceration CE Showing Ileal Ulceration

Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40

Page 12: 1 Literature Review Peter R. McNally, DO, FACP, FACG University Colorado School of Medicine Center for Human Simulation Aurora, Colorado 80045

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Patient Characteristics: Patient Characteristics: Gender:Gender: 11/13 (M/F)11/13 (M/F)Age: Age: 38 (18-71 yr)38 (18-71 yr)

Clinical CharacteristicsClinical CharacteristicsSmokersSmokers 50%50%

∆ ∆ time from surgerytime from surgery 254 days254 daysPerianal DiseasePerianal Disease 88%88%

SurgerySurgeryIleo-Ascending anastamosisIleo-Ascending anastamosis 67%67%

Ileo-Transverse anastamosisIleo-Transverse anastamosis 33%33%Length resection (cm)Length resection (cm) 34 (13-60)34 (13-60)

Disease Activity MarkersDisease Activity MarkersErythrocyte sedimentationErythrocyte sedimentation 19 (7-24)19 (7-24)C-reactive protein (0-8mg/L)C-reactive protein (0-8mg/L) 1.2 (0-6)1.2 (0-6)Crohn’s Disease Activity IndexCrohn’s Disease Activity Index 56 (23-168)56 (23-168)

Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40

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Results: CE vs.. IleocolonoscopyResults: CE vs.. Ileocolonoscopy

N =24N =24 ProcedureProcedure

FailureFailure

Crohn's (+)Crohn's (+)

Patency Patency M2AM2A

22/2422/24 2/24 ( 8.3%)2/24 ( 8.3%)

Non passageNon passage

CECE 21/2221/22 1/22 ( 4.5%)1/22 ( 4.5%)

Fail to Fail to transmittransmit

15/22 (62%)15/22 (62%)

13 proximal13 proximal

Ileocolon-Ileocolon-oscopyoscopy

24/2424/24 3/24 (12%)3/24 (12%)

Fail to Fail to intubateintubate

6/21 (25%)6/21 (25%)

Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40

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Results: Patient ComfortResults: Patient Comfort

• All patients preferred CE to endoscopyAll patients preferred CE to endoscopy• Bowel prep for endoscopy disrupted Bowel prep for endoscopy disrupted

daily activity more than liquid diet for CE daily activity more than liquid diet for CE (83% vs. 20%)(83% vs. 20%)

• 50% of the pts considered the 50% of the pts considered the endoscopy uncomfortableendoscopy uncomfortable

• 8/24 (33%) pts required additional 8/24 (33%) pts required additional conscious sedation during the neoileal conscious sedation during the neoileal explorationexploration

Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40

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Reviewer CommentsReviewer Comments

Beltran, et al, have clearly shown the following:Beltran, et al, have clearly shown the following:1.1. 2/24 (8.3%) non passage of patency capsule 2/24 (8.3%) non passage of patency capsule

suggests the need to evaluate luminal suggests the need to evaluate luminal patency before CE in asymptomatic post op patency before CE in asymptomatic post op Crohn’sCrohn’s

2.2. CE is superior to endoscopy (62% vs. 25%) CE is superior to endoscopy (62% vs. 25%) in the detection of active post operative in the detection of active post operative Crohn’s disease.Crohn’s disease.

3.3. CE is preferred by pts over endoscopy for CE is preferred by pts over endoscopy for evaluation of post operative Crohn’sevaluation of post operative Crohn’s

Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40

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Reviewer CommentsReviewer Comments

Beltran, et al, do not answer the question:Beltran, et al, do not answer the question:

1.1. Does detection of post operative Crohn’s Does detection of post operative Crohn’s disease by either method (endoscopy or CE) disease by either method (endoscopy or CE) make a difference in managing this disease?make a difference in managing this disease?

2.2. However, the authors will certainly have an However, the authors will certainly have an answer in the future. Those patients in this answer in the future. Those patients in this study with Rutgeerts’ score > 2 were offered study with Rutgeerts’ score > 2 were offered therapeutic modification with 2.5 mg/kg/day therapeutic modification with 2.5 mg/kg/day azathioprine.azathioprine.

Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40Beltran VP, et al. Gastrointest Endoscopy. 2007;66:533-40