Loading presentation...

Present Remotely

Send the link below via email or IM

Copy

Present to your audience

Start remote presentation

  • Invited audience members will follow you as you navigate and present
  • People invited to a presentation do not need a Prezi account
  • This link expires 10 minutes after you close the presentation
  • A maximum of 30 users can follow your presentation
  • Learn more about this feature in our knowledge base article

Do you really want to delete this prezi?

Neither you, nor the coeditors you shared it with will be able to recover it again.

DeleteCancel

Make your likes visible on Facebook?

Connect your Facebook account to Prezi and let your likes appear on your timeline.
You can change this under Settings & Account at any time.

No, thanks

Capsule Endoscopy

UCLA Journal Club
by

Guy Weiss

on 8 November 2013

Comments (0)

Please log in to add your comment.

Report abuse

Transcript of Capsule Endoscopy

CAPSULE ENDOSCOPY:
EASY PILL TO SWALLOW?

Overview
Background & Technical Aspects
Indications & C/I
Clinical Applications/ Obscure GIB

Overt UGIB (Gralnek et al & Chandran et al)

Other Accessories
Efficacy & Comparative Studies
Crohn’s Disease
Polyps & Tumors
Celiac disease

Endoscopy. 2013;45(1):12-9
Summary
Safe & relatively easy px to perform
Need for RCT in acute overt UGIB (sick pts)
Proven efficacy in OGIB, Crohn’s Disease, SB Polyps & Tumors, and Celiac disease
Limited application within the esophagus/colon
Future developments: improving visualization, allowing manipulation within the GIT and Bx capabilities

Journal Club, Nov 2013
Guy Weiss, MD, PGY 4
Mentor: Jeff Lewis, MD

Tel Aviv
Yoqneam
Given Imaging
Background
Provides visualization of the GIT by transmitting images wirelessly from a disposable capsule to a data recorder worn by the pt


Iddan G. Wireless capsule endoscopy, Nature 2000
GF
SB
TI
FDA-approved WC Systems & Specifications

Extended battery life (for delayed SB transit)

ASGE Technology Committee, Wireless capsule endoscopy, GIE. Oct 2013
WCE system
Consists of 3 components:
1. Capsule endoscope
2. Sensing system
3. Computer workstation
Capsule endoscope
(a) PillCam SB2 (Given Imaging, Yoqneam, Israel)
(b) EndoCapsule (Olympus America, Center Valley, PA)
(c) OMOM (Jinshan Science and Technology, Chongqing, China)
(d) MiroCam (IntroMedic, Seoul, Korea)
Leighton J, The Role of Endoscopic Imaging of the Small Bowel in Clinical Practice, AJG 2011
Sensing system
Data recorder unit
sensing pads
Sensing belt
(Real Time Viewer)
Personal computer workstation
Proprietary software:
RAPID v 6.5, Given Imaging
WS-1 EndoCapsule, Olympus America
MiroView, IntroMedic
Given Olympus
Real-time review
All 3 systems include handheld viewers that allow real-time review of images during WCE examinations:
RAPID Real-Time, Given Imaging
Real Time Viewer, Olympus America
Miro-View Express, IntroMedic
PillCam SB3
Optimized optics
Rapid movement detection: Automatic increased capturing rate (2-->6 frames/sec)

Patient Instructions
Setting: usually ambulatory outpt
Diet: NPO/CLD 10-12h (up to 24h CLD)
Prep: data are conflicting; likely use of full/partial bowel prep the night before yields improved SB visualization

Ben-Soussan E. Is a 2-liter PEG preparation useful before capsule endoscopy? J Clin G 2005
Dai . Improved capsule endoscopy after bowel preparation. GIE 2005
de Franchis R. ICCE consensus for bowel preparation and prokinetics. Endoscopy 2005.
Niv Y. Capsule endoscopy: role of bowel preparation in successful visualization. Scand J G 2004

Patient Instructions
The capsule is activated by removal from a magnetic holder

After ingestion, pts are instructed to:
Keep a diary of symptoms
Monitor recorder lights (confirming signal is received)
Avoid exercise/activities that may cause the sensors to detach
CLD is allowed after 2h and a light meal after 4h

Patient Instructions
The capsule is disposable & designed to be excreted
Pts are told to watch for passage of the capsule in their BM /requested to have AXR if entry into the colon is not observed during reading
Debris in distal SB & slow gastric emptying/ SB transit can preclude a full examination in 17%-25% of cases --> additional bowel prep / prokinetics/ longer battery-life systems

Rondonotti E. Complications, limitations, and failures of capsule endoscopy: a review of 733 cases. GIE 2005
Capsule Reading
ASGE guidelines:
Readers should undergo formal capsule training during fellowship/
complete GI/surgical society endorsed training course with proctoring of the first 10 capsule readings

Average reading time: 30-120 min
Dependent on SB transit time & experience of the reader
Esophagus reading: 5-15 min

Faigel DO. ASGE Guideline: guidelines for credentialing and granting privileges for capsule endoscopy. GIE 2005
Esophagus/ PillCam ESO2
FDA approved
(-) Battery life: 20 min (vs 8-12h)
Cameras are located on both ends of capsule
Captures 18 frames/sec (vs 2-3 frames/sec)
Applications:
Barrett’s esophagus
Esophagitis
Esophageal varices
Exact role in clinical practice has yet to be established
Eliakim R. A prospective study of the diagnostic accuracy of PillCam ESO esophageal capsule endoscopy versus conventional upper endoscopy in patients with chronic gastroesophageal reflux diseases. J Clin G 2005
Golding MI. Take your pill(cam): It might save your life. GIE 2005

Agile patency system
Delivery devices

Agile Patency System
Capsule retention proximal to intestinal stenosis is a well-recognized AE of WCE
Requiring endoscopic/surgical removal
Retained SB capsule at site of Crohn’s ileal stricture
Schnoll-Sussman F, Risks of Capsule Endoscopy,
Tech Gastro Endosc 2008
Agile Patency System
Radiopaque non-video capsule
Same dimensions as the PillCamSB2
Dissolvable body (lactose and 5% barium sulfate) at 30h
Several studies evaluated use in pts with retention risk:
Crohn’s disease, post-op, TB, and malignant strictures
All pts who attempted WCE after excreting an intact patency capsule w/o pain had uneventful exams



Herrerias JM. Agile patency system eliminates risk of capsule retention in patients with known intestinal strictures who undergo capsule endoscopy. GIE 2008
Banerjee R. Safety and efficacy of the M2A patency capsule for diagnosis of critical intestinal patency: results of a prospective clinical trial. J Gastro Hep 2007
Boivin ML. Does passage of a patency capsule indicate small-bowel patency? A prospective clinical trial. Endoscopy 2005
Cohen SA, Gralnek IM. The use of a patency capsule in pediatric Crohn’s disease: a prospective evaluation. Dig Dis Sci 2011
Signorelli C. Use of the Given patency system for the screening of patients at high risk for capsule retention. Dig Liver Dis 2006
Postgate AJ. Safety, reliability and limitations of the given patency capsule in patients at risk of capsule retention: a 3-year technical review. Dig Dis Sci 2008
Delivery Devices
Historically: overtubes (stomach)/polypectomy snares/nets (SB)
When?
Dysphagia
Gastroparesis
Anatomical abnormalities
This device has been tested and approved for use only with PillCam (EndoCapsule/MiroCam may be used with AdvanCE, but off-label )

The AdvanCE
(US Endoscopy, Mentor, Ohio)
Skogestad E. Capsule endoscopy: in difficult cases the capsule can be ingested through an overtube. Endoscopy 2004
Leung WK. Endoscopically assisted video capsule endoscopy. Endoscopy 2004
Toth E. Endoscopy-assisted capsule endoscopy in patients with swallowing disorders. Endoscopy 2004
Schnoll-Sussman F, Risks of Capsule Endoscopy, Tech Gastrointest Endosc 2008
MiroCam Navi Magnetically controlled WC
Capsule paired with a magnetic wand
Assists with mobilizing the device
When?
Delayed gastric emptying
Available outside of USA
Not FDA-approved

INDICATIONS AND CONTRAINDICATIONS
Relative Contraindications
Known/suspected GI obstruction/strictures/fistulas based on the clinical picture or pre-px testing
Cardiac PM or other implanted electro-medical devices
Swallowing disorders
Pregnancy

Safety/ Capsule Retention
In general: safe px
Defined as remaining in the GIT >2w/ required directed Tx to aid its passage
Associated with:
NSAID strictures
Crohn’s disease
SB tumors
Radiation enteritis
Surgical anastomotic strictures
Other: Zenker’s diverticulum, duodenal diverticulum, umbilical hernia, Meckel’s diverticulum
AXR after 2w if retention is suspected
If confirmed: Sx or endoscopic intervention

Capsule Retention
Safety/ Other Complications
Intestinal perforation (2 pts with Crohn’s Disease)
Tracheal aspiration
? interference between transmitted capsule wavelengths and PM/ICD/LVAD (<10cm from pacer)

No MRI until WCE has passed

The overall incidence of capsule retention reported 0%-13%
Associated with indication
However, recent studies: < 1.4%
from 22,840 procedures
1.2%
2.6%
2.1%
Cheifetz AS. The risk of retention of the capsule endoscope in patients with known or suspected Crohn's disease. AJG 2006
Hoog CM. Capsule retentions and incomplete capsule endoscopy examinations: an analysis of 2300 examinations. Gastroenterol Res Pract 2012
Liao Z. Indications and detection, completion, and retention rates of small-bowel capsule endoscopy: a systematic review. GIE 2010

OGIB
Diagnostic yield of WCE: 35%-77%

Higher detection rate:
Earlier WCE (within 1w of bleeding)
Inpt status
Overt GIB requiring PRBC
Male
Older
Coumadin use
Liver comorbidity

Estevez El. Diagnostic yield and clinical outcomes after capsule endoscopy in 100 consecutive patients with obscure gastrointestinal bleeding. Eur J Gastro Hep 2006
Lecleire S. Yield and impact of emergency capsule enteroscopy in severe obscure-overt gastrointestinal bleeding. Endoscopy 2012
Robinson CA. Impact of inpatient status and gender on small-bowel capsule endoscopy findings. GIE 2011
van Turenhout ST. Diagnostic yield of capsule endoscopy in a tertiary hospital in patients withobscure gastrointestinal bleeding. J Gastro Liver Dis 2010
Yamada A. Timing of capsule endoscopy influences the diagnosis and outcome in obscure-overt gastrointestinal bleeding. Hepatogastro 2012
Sidhu R. Factors predicting the diagnostic yield and intervention in obscure gastrointestinal bleeding investigated using capsule endoscopy. J Gastro Liver Dis 2009
Albert JG. Impact of capsule endoscopy on outcome in mid-intestinal bleeding: a multicentre cohort study in 285 patients. Eur J Gastro Hep 2008
Esaki M. Factors associated with the clinical impact of capsule endoscopy in patients with overt obscure gastrointestinal bleeding. Dig Dis Sci 2010
Lepileur L. Factors associated with diagnosis of obscure gastrointestinal bleeding by video capsule enteroscopy. Clin Gastro Hep 2012

OGIB/
WCE impacts management & outcomes
Retrospective study
75 pts with overt (48%) or occult (52%) OGIB
Diagnostic yield: 66.7%
WCE changed clinical management in 61.4%:
Sx
medical Tx
NSAID withdrawal
31 pts had 6m F/U
30/31: resolution of bleeding
Lower yield for hematochezia

Redondo-Cerezo E. Diagnostic yield and impact of capsule endoscopy on management of patients with gastrointestinal bleeding of obscure origin. Dig Dis Sci 2002 (Spain)
OGIB/
Prospective study
78 pts with OGIB
35 (44.9%) had significant lesions
11 insignificant lesions
>6m F/U
Re-bleeding rates

WCE predicts outcomes
Iwamoto J. The clinical outcome of capsule endoscopy in patients with obscure gastrointestinal bleeding. Hepatogastro 2011 (Japan)
26.1%
4%
OGIB/ Capsule > Radiology
WCE achieves superior results vs barium studies


Meta-analysis of 3 studies (n = 88) found
diagnostic yield-


single-blinded study, 25 inpts with overt/occult OGIB found
diagnostic yield-
Consequently, Tx intervention: in 47% of pts

42%
6%
P < .00001
72%
24%
56%
p<0.05
P=NS
Hara AK. Small bowel: preliminary comparison of capsule endoscopy with barium study and CT. Radiology 2004
Costamagna G. A prospective trial comparing small bowel radiographs and video capsule endoscopy for suspected small bowel disease. Gastroenterology 2002
Laine L. Does capsule endoscopy improve outcomes in obscure gastrointestinal bleeding? Randomized trial versus dedicated small bowel radiography. Gastroenterology 2010
Triester SL. A meta-analysis of the yield of capsule endoscopy compared to other diagnostic modalities in patients with obscure gastrointestinal bleeding. AJG 2005
Saperas E. Capsule endoscopy versus computed tomographic or standard angiography for the diagnosis of obscure gastrointestinal bleeding. AJG 2007

OGIB/ WCE = intraoperative enteroscopy
Historically, intraop enteroscopy was used to evaluate the entire SB
47 consecutive pts with OGIB
WCE > intraoperative enteroscopy bleeding diagnosis: 74.5% vs 72% (P=NS)
Compared with intraoperative enteroscopy:
Sensitivity 95%
Specificity 75%
PPV 95%
NPV 86%

Hartmann D. A prospective two-center study comparing wireless capsule endoscopy with intraoperative enteroscopy in patients with obscure GI bleeding. GIE 2005
OGIB/ WCE> Push Enteroscopy
Pooled analysis
14 prospective studies
396 pts with OGIB
Diagnostic yield

78 consecutive pts with OGIB
Randomized for WCE / push enteroscopy
Identification of a bleeding source
WCE+push: WCE found unidentified lesions in 26% of cases vs 8% for push enteroscopy

56%
26%
P< .00001
50%
24%
P=.02
Triester SL. A meta-analysis of the yield of capsule endoscopy compared to other diagnostic modalities in patients with obscure gastrointestinal bleeding. AJG 2005
de Leusse A. Capsule endoscopy or push enteroscopy for first-line exploration of obscure gastrointestinal bleeding? Gastroenterology 2007

OGIB/ DBE=WCE
Kameda N. A prospective, single-blind trial comparing wireless capsule endoscopy and double-balloon enteroscopy in patients with obscure gastrointestinal bleeding. J Gastroenterol 2008
Chen X. A meta-analysis of the yield of capsule endoscopy compared to double-balloon enteroscopy in patients with small bowel diseases. WJG 2007
Pasha SF. Double-balloon enteroscopy and capsule endoscopy have comparable diagnostic yield in small-bowel disease: a meta-analysis. Clin Gastro Hep 2008
Arakawa D. Outcome after enteroscopy for patients with obscure GI bleeding: diagnostic comparison between double-balloon endoscopy and videocapsule endoscopy. GIE 2009
Marmo R. Degree of concordance between double-balloon enteroscopy and capsule endoscopy in obscure gastrointestinal bleeding: a multicenter study. Endoscopy 2009
Haifa
Acute Overt UGIB
UGIB is prevalent & clinically significant
Costly healthcare problem worldwide
The incidence of acute overt GIB : 50–150 cases per 100k adults in US (150k-450k annually)
Resulting in total direct costs of more than one billion dollars annually


Gralnek IM .Management of acute bleeding from a peptic ulcer. NEJM 2008
Adam V. Estimates of costs of hospital stay for variceal and non variceal upper gastrointestinal bleeding in the United States. Value in Health 2008
Esrailian E. Non-variceal upper gastrointestinal bleeding: epidemiology and diagnosis. Gastro Clin North Am 2005
Boonpongmanee S. The frequency of peptic ulcer as a cause of upper-GI bleeding is exaggerated. GIE 2004


Hypothesis

WCE is more accurate than NGT aspiration in identifying UGIT blood (fresh red blood/coffee ground)
Proof-of-concept pilot study
Evaluate the feasibility and safety of using WCE in pts presenting to the ED with acute overt GIB

Rubin M. Live view video capsule endoscopy enables risk stratification of patients with acute upper GI bleeding in the emergency room: a pilot study. Dig Dis Sci 2011
Patients & Methods
2 center prospective cohort study
Rambam Health Care Campus, Haifa, Israel
Prince of Wales Hospital, Hong Kong, China
08/2009-10/2010
Written informed consent
Helsinki Committee Approval

Inclusion Criteria
age≥18 years
Presenting to ED with acute overt UGIB: hematemesis (fresh blood/coffee ground) and/or melena within 48h

Exclusion Criteria
Dysphagia/odynophagia/swallowing d/o
Zenker’s diverticulum
Suspected bowel obstruction/ perforation
Hemorrhagic shock requiring urgent EGD
Hx bowel obstruction
Gastroparesis/ known gastric outlet obstruction
Crohn’s disease
Hx GI Sx (Billroth I, Billroth II, gastrectomy, esophagectomy, or bariatric sx)
PM/AICD

AMS (HE) limiting capsule swallowing
Pregnancy/ lactation
Allergy to conscious sedation medications/ erythromycin
Unwillingness to swallow capsule
Possibility of requiring MRI within 7d
Use of medications that coat UGIT (antacids/sucralfate)
Inability to consent

Study Design
Recorded BL pt data
:
DOB/sex
Presenting signs/symptoms of acute UGIB
Hemodynamic status: HR/BP/orthostatics
PMH/PSH
Meds: aspirin, plavix, NSAID, anticoagulants
Labs: H&H, WBC, PLT, INR, LFT, electrolytes, Cr/BUN

PillCamESO2 ingestion within 6h of presentation
2 video cameras, doubled field of view, increased depth of view, increased frame rate, improved image quality, and adjusted illumination
Used modified capsule with battery life of 90min


Barkun AN. Prokinetics in acute upper GI bleeding: a meta-analysis. GIE 2010
Study Design
Use of a real-time viewer at bedside
Once capsule entered duodenum (by real-time viewer)/ battery died: NGT placed for lavage/aspiration of gastric contents
NGT aspirate was recorded: clear/bilious, coffee ground, or fresh blood
NGT was left to drain under gravity (to avoid gastric mucosal trauma)

Bloody NGT lavage is an (-) prognostic sign: identifying pts who require more urgent EGD (FN: 15%)

Aljebreen AM. Nasogastric aspirate predicts high-risk endoscopic lesions in patients with acute upper-GI bleeding. GIE 2004
Study Design
EGD performed within 12-24h of presentation
Under conscious sedation (IV Veresed +/- fentanyl / propofol)
Single dose of IV erythromycin was also given 30–60min prior to EGD
Endoscopist blinded to WCE/NGT findings
WCE recordings were reviewed, reader blinded to real-time reading/NGT/EGD
Pt satisfaction: measured via standardized (1-5) questionnaire post-capsule, post-NGT, post-EGD

Study Endpoints
Primary endpoint:

Identification of gross blood (fresh/coffee ground) by capsule (vs NGT)

Secondary study endpoints:
Ability of capsule to detect peptic/inflammatory mucosal lesions (vs EGD)
Differentiation between variceal /non-variceal bleeding
Evaluation of adverse events, technical failures of the capsule, and inability to reach D2
Evaluation of pt satisfaction

Statistical Analyses
Pilot feasibility study --> no statistical power calculated a priori
Demographics & BL characteristics reported with summary statistics
A frequency table for qualitative data
McNemar test
to evaluate the diagnostic yield of gross blood: capsule vs NGT
to evaluate the diagnostic yield of detection of inflammatory lesions: capsule vs EGD (and later w/o ulcerations)

Results
Baseline data & Demographics (n=49)
41 HK / 8 Israel

Results
Primary Outcome/Blood detection
n=18/41 (blood detected by either/both techniques)
n=12
66%
n=3
17%
n=3
17%
Primary Outcome/Blood detection
n=15
83.3%
n=18
n=6
33.3%
p=0.035
clear/bilious NGT reported in 7/9 pts with WCE blood in duodenum
Secondary Outcome/Inflammatory lesion detection
Including ulcers (n=40) Excluding ulcers (n=25)
n=27
67.5%
n=35
87.5%
P=0.10 P=0.39

n=17
68%
n=21
84%
No significant difference found between WCE and EGD for inflammatory lesion identification
Other Secondary Outcomes
Nonbleeding varices: n=4
3 (75 %) detected by WCE & EGD
1 by EGD alone

Capsule reached the duodenum in 45/46 patients (97.8 %)

AE (n=46):
1 (2.2 %) with self-limited SOB
1 (2.2 %) cough during capsule ingestion

Secondary Outcome/Pt Satisfaction
(2) Wilxocon signed rank test
Willingness to repeat Px if indicated in the future
84.1%
55%
28%
PillCamESO2
Gastric ulcer with oozing blood
Fresh blood from a gastric ulcer
Coffee ground in duodenum
Discussion
Prospective multicenter design

Capsule endoscopy risk stratification:
DC from ED with GI F/U vs admission (non-tele vs tele vs ICU)
Early EGD for high-risk vs no EGD for low-risk (erosive esophagitis or gastritis/duodenitis)
Reduce healthcare costs: admission, PPI gtt, Octreotide gtt

Conclusions
WCE appears feasible and safe in UGIB (ED)
WCE > NGT in detecting gross blood
WCE=EGD in identifying inflammatory lesions
WCE=EGD in excluding gastric/duodenal ulcers

Need for larger RCT, to prove cost-effectiveness & improved outcomes

Limitations
Small sample size
Very stable pt population
Pilot study
Time lag & erythro between (+) capsule/(-) NGT (blood cleared?)
Unclear protocol of NGT (aspirate/lavage/cc?)
Researchers are consultants for GIVEN Imaging, Ltd (study sponsor)
Did the capsule improve outcomes? Need for endoscopic intervention?
Inflammatory lesions diagnosis:
EGD 84% vs WCE 68% (P=NS)
However, concordant findings: only in 15 pts (32.6%)
4 pts (8.7%) with (-) EGD/(+) WCE
13 pts (28.2%) with (+)EGD/(-)WCE

Prox SB AVM
$500/10 capsules
$495/3 devices
(Navi Capsule, IntroMedic, Seoul, Korea)

Obscure GIB


Overt UGIB
Efficacy & Comparative Studies
Crohn’s Disease
Polyps & Tumors
Celiac disease

Swain P. Capsule endoscopy in obscure intestinal bleeding. Endoscopy 2005
Swain P. Wireless capsule endoscopy and Crohn’s disease. Gut 2005
Cave D. Capsule endoscopy and Crohn’s disease. Gastrointest Endosc 2005
Kornbluth A. Video capsule endoscopy in inflammatory bowel disease: Past, present, and future. Inflamm Bowel Dis 2004.
Burke CA. The utility of capsule endoscopy small bowel surveillance in patients with polyposis. AJG 2005
Mata A. A prospective trial comparing wireless capsule endoscopy and barium contrast series for small-bowel surveillance in hereditary GI polyposis syndromes. GIE 2005
Schulmann K. Feasibility and diagnostic utility of video capsule endoscopy for the detection of small bowel polyps in patients with hereditary polyposis syndromes. AJG 2005
Caspari R. Comparison of capsule endoscopy and magnetic resonance imaging for the detection of polyps of the small intestine in patients with familial adenomatous polyposis or with Peutz-Jeghers’ syndrome. Endoscopy 2004
Soares J. Wireless capsule endoscopy for evaluation of phenotypic expression of small-bowel polyps in patients with Peutz-Jeghers’ syndrome and in symptomatic first degree relatives. Endoscopy 2004
Culliford A. The value of wireless capsule endoscopy in patients with complicated celiac disease. GIE 2005
Petroniene R. Given capsule endoscopy in celiac disease: evaluation of diagnostic accuracy and interobserver agreement. AJG 2005
Petroniene R. Given capsule endoscopy in celiac disease. Gastro Endosc Clin N Am 2004
Joyce AM. Capsule endoscopy findings in celiac disease associated enteropathy-type intestinal T-cell lymphoma. Endoscopy 2005


Obscure GIB


Overt UGIB
Diagnostic Yield
The likelihood that a test/px will provide the information needed to establish a dx
# pts with positive diagnostic test
# pts tested
=
WCE impacts Management
WCE impacts Outcomes
WCE vs Radiology
WCE vs IntraOp/Push/DB Enteroscopy
OGIB
What is the role of WCE in the initial evaluation and pre-EGD risk stratification?
What is the role of WCE compared to NGT lavage in bleeding source detection?
Acute UGIB/ Risk Stratification
Acute UGIB
Scoring Tools
Glasgow-Blatchford Score
The Rockall Score
Facilitate triage
Identify those in need of urgent endoscopy
Predict the risk of poor outcome
Guide subsequent management
Therapeutic EGD <24h improves outcomes (reduced re-bleeding, PRBC, Sx, mortality)
80% in US undergo EGD <24h
Khamaysi I. Acute upper gastrointestinal bleeding (UGIB) - Initial evaluation and management. Best Pract Res Clin Gastro 2013
Evaluation and management of obscure GIB

IOE: Intraop enteroscopy
BAE: Balloon-assisted enteroscopy
Mergener K. Literature review and recommendations for clinical application of small-bowel capsule endoscopy, based on a panel discussion by international experts. Endoscopy. 2007
Leighton J, The Role of Endoscopic Imaging of the Small Bowel in Clinical Practice, AJG 2011

Statistical Analyses
Wilcoxon signed rank test
: to compare pt satisfaction for each Px

Used to compare 2 related samples/matched samples/
repeated measurements on a single sample
Mann–Whitney–Wilcoxon test cannot be used since it requires independent observations from both groups
Data are paired and come from the same population
Each pair is chosen randomly and independent
McNemar's test
Applied to 2×2 tables
Dichotomous trait
Matched pairs of subjects
Pearson's chi-squared test cannot be used
Comparison of outcomes of two tests



McNemar test P=0.035
P<.05
Wilcoxon signed rank test

Mean length of stay for GIB 4.5d = $26,210

Physician Medicare national average fee for PillCamEso2= $755

NGT= $2.99
Cost-effectiveness
Weber FH, Capsule endoscopy for acute upper gastrointestinal bleeding: is the cherry ripe yet? Ensocopy 2013 
Substitute or an additional cost?
--> WCE cannot substitute EGD
Capsule endoscopy in Severe Hematochezia
Capsule endoscopy < EGD for Variceal Screening in Cirrhotics
65 cirrhotic pts w/o hx of GIB
Examined for varices & HRVLs by WCE (PillCamEso) & EGD (same day)
Median px time: EGD 3 min vs WCE 20 min
Overall accuracy for esophageal varices dx: 63.2% +/- 5.9%;
Overall accuracy for esophageal varices red marks dx: 68.8% +/- 5.4%;
WCE is not as accurate as EGD
for dx/grading of esophageal varices/red markings/PHG/ulcers/gastric varices & takes significantly longer to perform/interpret

Chavalitdhamrong D, Jensen D, Singh B, Kovacs T, Han S, Durazo F, Saab S, Gornbein J, Capsule Endoscopy Is Not as Accurate as Esophagogastroduodenoscopy in Screening Cirrhotic Patients for Varices. Clinical Gastro Hep 2013/ in press
DDW2013
Courtesy of Dr. Jensen
The End
Volume 77, No. 6 : 2013 GASTROINTESTINAL ENDOSCOPY
Department of Gastroenterology, Austin Health, Heidelberg, Victoria, Australia
Rubin M. Live view video capsule endoscopy enables risk stratification of patients with acute upper GI bleeding in the emergency room: a pilot study. Dig Dis Sci 2011
Hearnshaw SA. Use of endoscopy for management of acute upper gastrointestinal bleeding in the UK: results of a nationwide audit. Gut 2010

Can esophageal capsule identify low-risk pts with UGIB for elective EGD




Non-randomized, single-blinded safety- efficacy study
9/2009-12/2011
3 centers: Austin Health, the Northern Hospital, and Alfred Health in Victoria, Australia


Inclusion criteria
Age>18 y
Able to consent
Willing to undergo WCE in addition to EGD

Exclusion Criteria
Dysphagia
Zenker’s diverticulum
Pregnancy
Esophageal stricture
Gastric/intestinal obstruction
Gastroparesis
Multiple abdominal sx
Cognitive impairment
Hemodynamic instability

IRB approval/ in accordance with the Declaration of Helsinki
Written consent obtained

Data recorded:
Pt info
Blatchford/Rockall scores
Time to px
Findings
Adverse events

Methods
Objective
Methods
Design & Definitions
PillCamESO (first generation), 20min
IV reglan 10mg given 30min pre-WCE
WS reading

Low-risk pts per WCE:
Forrest score III for PUD (clean-base)
Lesions that did not require urgent endoscopic Tx (but medical Tx alone, i.e. non-bleeding Mallory-Weiss tears)
High risk:
Forrest score I/II
Evidence of GIB
Poor mucosal views/lack of duodenal visualization

Outcome Measures
Primary endpoints:
Detection rate of acute GIB
Assessment of those who could have been D/C from ED

Secondary endpoints:
Tolerability of WCE
Cost comparison: WCE vs EGD

Statistical analysis
Descriptive statistics for pt characteristics
Statistical analysis performed with SPSS (version 19.0)

Results/ Detection of UGIB
Median time for Px:
WCE <15h
EGD <23h

Duodenal visualization with WCE: 53%
WCE Dx failure was associated with no duodenal visualization in 7 of 21 pts

WCE EGD
PHG-related ooze
Gastric coffee-ground bleeding
(Forrest 2B gastric ulcer on EGD)
Active small-bowel bleeding
(ulcerated jejunal polyp on BE)
Results/
Patient Characteristics
Sensitivity & Specificity of PillCamESO vs Blatchford Score
In entire study population
In subgroup with
duodenal visualization
(n=44)
75%
WCE: 66%
EGD: 89%
Concordant: 55%
38%
25%
Identification of low-risk UGIB
(=outpt EGD)
EGD: 25 pts
WCE: 23/25 (92%)
Blatchford: 4/25 (16%)

Cost analysis of PillCamESO–based triage of UGIB

WCE $895
Outpt EGD $1493








1 Australian Dollar=0 .95USD
Daily bed costs up $1100
Inpt EGD $2384
The total cost of cohort
$788,572
Cost equivalent
The total cost of cohort
$788,453
In the subgroup (duo visualization): $280,421 vs $354,825
=saving of $74,404 ($1691/pt)

Outcomes of pts with (-)EGD/(-)WCE
21 pts
6m F/U
2 CRC at subsequent colonoscopy
1 recurrent anemia: gastric vascular ectasia on repeat EGD

Discussion
1 (1%) symptomatic SB capsule retention (resolved with conservative management)

Safety
WCE with duodenal visualization: 23/25 (92%) pts can be managed as outpt (5-fold increase vs Blatchford score)
Health care cost reduction
8% of total pt population with lesions detected only by WCE/ (-)EGD

Limitations:
Low duodenal visualization rate with WCE (53%)
No real-time reading

p=0.025
definite/suspected
WCE: (+) Noninvasive
(+) Likely total SB enteroscopy
(- ) No Tx
Acute UGIB/ Risk Stratification
Scoring Tools
Glasgow-Blatchford Score
The Rockall Score
NGT lavage
Facilitate triage
Identify those in need of urgent endoscopy
Predict the risk of poor outcome
Guide subsequent management
Capsule?
Khamaysi I. Acute upper gastrointestinal bleeding (UGIB) - Initial evaluation and management. Best Pract Res Clin Gastro 2013
(ulceration, erosions, erythema, esophagitis, duodenitis, gastritis)
Full transcript