spiral enteroscopy: prospective multicenter u.s. trial in patients with small bowel disorders

2
803 Is Endoscopic Ultrasound Guided Brachytherapy (EUS-BrTx) Useful for the Treatment of Recurrent Malignant Lymph Nodes? Reiko Ashida, Susumu Shinoura, Makoto Nishimura, Raman Muthusamy, John G. Lee, Kenneth J. Chang Background: Brachytherapy is an established treatment for various cancers such as head and neck, lung, and most commonly prostate cancer. For GI malignancies, brachytherapy has been used for esophageal, pancreatic and rectal cancer. Although it has many advantages (minimal toxicity to surrounding organs, single session delivery, etc) one of its major limitations is delivery access. EUS-guided Brachytherapy (EUS-BrTx) is a newly reported technique. However, outcomes data is limited. We report our experience with EUS-BrTx in 5 patients with recurrent cancer. Patient and Method: Four patients with esophageal cancer and one patient with duodenal cancer had pathologically confirmed recurrent malignant lymph nodes. EUS-BrTx was performed as part of an IRB approved protocol using 19G FNA needle (Cook Medical Inc, Bloomington, IN)) and either iodine I125 or palladium Pd103 seeds. Four patients required only a single session while one patient underwent four sessions for recurrent LNs over a span of 9 months. A total of 11 LNs were treated. Two patients had chemotherapy following EUS-BrTx. Result: All LNs were successfully implanted with radioactive seeds via EUS without any procedure related complications. The median size of LNs was 16.2 x 10.5 mm(range 9.5 x 8.2 - 35.9 x 37.0mm). The median number of implanted seeds was 3.5 (1 - 12). On follow up EUS or CT, seven out of 11 LNs(63.6 %) showed decrease in size or disappearance. Two out of 11 LNs (18.2%) did not change in size and 2 out of 11 LNs(18.2%) showed increase in size. Three patients are still alive without any signs of recurrence with a mean survival of 11 months from time of EUS-BrTx. Conclusion: EUS-BrTx is a safe and feasible procedure with an 82% control rate for locally recurrent LNs in a small series. Case1 No of LN Disease Size of LN (pre) Size of LN (post) Change No of seeds Combination therapy Survival 1 Eso CA 12.5 x 7.8(mm) 8.2 x 3.0 (mm) Y 2 N/A 6 mo dead 2 13.5 x 7.7 4.7 x 3.2 Y 1 N/A 3 10.3 x 9.3 14.0 x 9.9 [ 2 N/A 4 15.0 x 7.0 30.0 x 12.0 [ 2 N/A 5 18.0 x 7.0 19.0 x 4.0 Z 2 N/A 6 15.0 x 10.0 not detected Y 2 N/A Case2 7 Eso CA 17.1 x 5.7 not detected Y 2 N/A 24 mo dead Case3 8 Eso CA 20.0 x 10.0 20.0 x 10.0 Z 9 N/A 14 mo alive Case4 9 Eso CA 9.5 x 8.2 not detected Y 3 Chemo 8 mo alive 10 Eso CA 11.5 x 5.9 not detected Y 2 Chemo Case5 11 Duodenal CA 35.9 x 37.0 not detected Y 12 Chemo 12 mo alive 915 Prospective Multicenter Trial Comparing Double Balloon Enteroscopy (DBE) and Single Balloon Enteroscopy (SBE) in Patients with Suspected Small Bowel Disorder Andrea May, Michael Fa ¨Rber, Insa Aschmoneit, Juergen Pohl, Hendrik Manner, Erich Lotterer, Oliver Moeschler, Liebwin Gossner, Klaus Mo ¨Nkemu ¨Ller, Martin Raithel, Stephan Miehlke, Christian Ell Background: DBE has become established throughout the world for diagnostic and therapeutic small bowel endoscopy. SBE has been introduced as a simplification of the balloon enteroscopy technique.Objective/Study Design: Prospective comparison of the double and single ballon technique of small bowel endoscopy. Complete enteroscopy was choosen as study endpoint, because it is the most objective parameter. DBE was considered to reach more than double a complete enteroscopy compared to SBE (40% versus 15%). Number of patients needed to be investigated for this hypothesis was calculated with 98 randomised patients. Only diagnostic or therapeutic examinations with argon plasma coagulation up to 5 angiodysplasias were included. Patients with prior colon and small bowel surgery had been excluded. Material and Methods: 117 pats. had been enrolled into the study, after exclusion of 17 patients (e.g. due to tumor stenosis, necessary therapeutic interventions etc.) 100 pats. (50 for each group) (63 male, 37 female) with a mean age of 55 years finished the study successfully. Reason for small bowel endoscopy had been (suspected) mid GI bleeding (nZ60), (suspected) Crohn’s disease (nZ 12), suspected small bowel masses (nZ7) and others (nZ21). For small bowel endoscopy the Fujinon device (EN450-P5) was used either with two or with one balloon. Results: All balloon enteroscopies had been performed without severe complications. The preparation time of the SBE device had been significantly (p!0.0001) faster compared with the DBE device. There was no significant difference regarding the investigation time. Complete enteroscopy was done with the DBE device in 66 % (33 patients) either with the oral route alone or with combination of oral and anal approach, whereas with the SBE device the rate was significantly (p!0.0001) less with 22% (11 patients, only combination of oral and anal route). The diagnostic yield regarding relevant findings had been 50% using DBE and 42% using SBE. Not included in this diagnostic yield rate are the normal examinations for exclusion of relevant findings or determination of the extension of a known disease, where only a complete small bowel endoscopy can give this important information. Conclusion: With the DBE technique the rate of complete enteroscopy had been approximately three fold higher than with the SBE technique going along with a higher diagnostic yield. Therefore DBE must continue to be regarded as the gold standard procedure for deep small bowel endoscopy. 916 Severe Complications of Spiral Enteroscopy in the First 1750 Patients Paul A. Akerman, Daniel Cantero Serious complications of deep small bowel enteroscopy occur infrequently. In published series, severe complications occur in deep small bowel enteroscopy in 0.3 to 4% of cases. The aim of this study is to publish all recognized serious complications occuring during spiral enteroscopy. Patients, Methods, and Materials: There were 1750 patients who underwent spiral enteroscopy from August,2005 until November 2008. Cases have been performed in North America and Europe. Data was collected from device representatives and a survey of device users. The device used in all cases was the Discovery SB which is 118 cm long with a hollow spiral 5.5 mm high and 22 cm long with a scope coupler on the proximal end. The Discovery SB has an outer diameter of 16 mm and an internal diameter of 9.8 mm. The enteroscopes used in the examinations were 9.2 mm Olympus SIF-180 and 9.4 mm Fujinon EN450T-5 200 cm enteroscopes. Severe complications were defined as pancreatitis, nontransient intussusception, severe pain after the procedure requiring admission to the hospital, bleeding requiring transfusion or admission to the hospital, cardio-pulmonary arrest during a procedure and perforation. Results: There were no reported complications of pancreatitis, esophageal or gastric perforations, severe bleeding requiring transfusion, cardio-pulmonary arrests or deaths during or resulting from the spiral enteroscopy procedures. There were 7 severe complications(0.4%) reported as a result of the procedure. Six were small bowel perforations(0.34%). All were recognized immediately when the scope tip entered the peritoneum. Of these, three small bowel perforations occured in the duodenum and three occurred in the jejunum. All perforations occurred while pushing to advance the scope through the stationary overtube. None of the perforations occured during therapeutic interventions. None of the perforations occurred during rotation of the overtube to pleat the small bowel. Three of the perforations occurred when the experience of the physician was less than 10 cases. One patient experienced severe pain after the procedure and was admitted for observation. The patient did not require intervention and was later discharged. Conclusion: The overall severe complication rate was 0.4% and a perforation rate of 0.34%. All of the perforations were recognized immediately when the scope tip visualized the peritoneum. Perforations may be minimized by advancing the enteroscope only when the lumen is clearly visualized. 917 Spiral Enteroscopy: Prospective Multicenter U.S. Trial in Patients with Small Bowel Disorders Douglas Morgan, Bennie R. Upchurch, Peter V. Draganov, Kenneth F. Binmoeller, Oleh Haluszka, Sreenivasa Jonnalagadda, Patrick Okolo, Ian S. Grimm, Michael V. Chiorean Background: Deep enteroscopy (DBE, SBE) has revolutionized management of patients with mid-small bowel disorders. Spiral enteroscopy(SE) is a novel approach coupling a standard balloon enteroscope with a spiral overtube. Aims of the present study were to determine the performance, yield and safety of SE in patients with suspected or established small bowel pathology. Methods: Prospective, multicenter study with centralized standard database. Patients referred for anterograde enteroscopy were eligible. Patients with a history of esophageal stricture, advanced cirrhosis, or coagulopathy were excluded. The depth of insertion was measured using a standard algorithm. The mean adjusted diagnostic procedure time was calculated for all procedures: total time minus therapy time. Results: 148 patients were enrolled at 10 centers in the U.S. with a median age of 68 (42% male). Co-morbid conditions were common: CAD 37.4%, CHF 12%, COPD 16%, prior abdominal/pelvic surgery 55%. Chronic medication use: ASA 27%, clopidogrel 12%, warfarin 6.3%. Obscure GI bleeding(72%) was the most common indication, of which 32% were overt and 62% had been transfused within 6 months. Abstracts www.giejournal.org Volume 69, No. 5 : 2009 GASTROINTESTINAL ENDOSCOPY AB127

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Abstracts

803

Is Endoscopic Ultrasound Guided Brachytherapy (EUS-BrTx)

Useful for the Treatment of Recurrent Malignant Lymph Nodes?Reiko Ashida, Susumu Shinoura, Makoto Nishimura, Raman Muthusamy,John G. Lee, Kenneth J. ChangBackground: Brachytherapy is an established treatment for various cancers such ashead and neck, lung, and most commonly prostate cancer. For GI malignancies,brachytherapy has been used for esophageal, pancreatic and rectal cancer.Although it has many advantages (minimal toxicity to surrounding organs, singlesession delivery, etc) one of its major limitations is delivery access. EUS-guidedBrachytherapy (EUS-BrTx) is a newly reported technique. However, outcomes datais limited. We report our experience with EUS-BrTx in 5 patients with recurrentcancer. Patient and Method: Four patients with esophageal cancer and one patientwith duodenal cancer had pathologically confirmed recurrent malignant lymphnodes. EUS-BrTx was performed as part of an IRB approved protocol using 19GFNA needle (Cook Medical Inc, Bloomington, IN)) and either iodine I125 orpalladium Pd103 seeds. Four patients required only a single session while onepatient underwent four sessions for recurrent LNs over a span of 9 months. A totalof 11 LNs were treated. Two patients had chemotherapy following EUS-BrTx. Result:All LNs were successfully implanted with radioactive seeds via EUS without anyprocedure related complications. The median size of LNs was 16.2 x 10.5 mm(range9.5 x 8.2 - 35.9 x 37.0mm). The median number of implanted seeds was 3.5 (1 - 12).On follow up EUS or CT, seven out of 11 LNs(63.6 %) showed decrease in size ordisappearance. Two out of 11 LNs (18.2%) did not change in size and 2 out of 11LNs(18.2%) showed increase in size. Three patients are still alive without any signsof recurrence with a mean survival of 11 months from time of EUS-BrTx.Conclusion: EUS-BrTx is a safe and feasible procedure with an 82% control rate forlocally recurrent LNs in a small series.

No Size Size Change No of Combination Survival

Case1

www.

ofLN

giejo

Disease

urnal.or

of LN(pre)

g

of LN(post)

seeds

therapy

1

Eso CA 12.5 x7.8(mm)

8.2 x 3.0(mm)

Y

2 N/A 6 modead

2

13.5 x7.7

4.7 x 3.2

Y 1 N/A

3

10.3 x9.3

14.0 x9.9

[

2 N/A

4

15.0 x7.0

30.0 x12.0

[

2 N/A

5

18.0 x7.0

19.0 x4.0

Z

2 N/A

6

15.0 x10.0

notdetected

Y

2 N/A

Case2

7 Eso CA 17.1 x5.7

notdetected

Y

2 N/A 24 modead

Case3

8 Eso CA 20.0 x10.0

20.0 x10.0

Z

9 N/A 14 moalive

Case4

9 Eso CA 9.5 x 8.2 notdetected

Y

3 Chemo 8 moalive

10

Eso CA 11.5 x5.9

notdetected

Y

2 Chemo

Case5

11 DuodenalCA

35.9 x37.0

notdetected

Y 1

2 Chemo 12 moalive

915

Prospective Multicenter Trial Comparing Double Balloon

Enteroscopy (DBE) and Single Balloon Enteroscopy (SBE) in

Patients with Suspected Small Bowel DisorderAndrea May, Michael FaRber, Insa Aschmoneit, Juergen Pohl,Hendrik Manner, Erich Lotterer, Oliver Moeschler, Liebwin Gossner,Klaus MoNkemuLler, Martin Raithel, Stephan Miehlke, Christian EllBackground: DBE has become established throughout the world for diagnostic andtherapeutic small bowel endoscopy. SBE has been introduced as a simplification ofthe balloon enteroscopy technique.Objective/Study Design: Prospectivecomparison of the double and single ballon technique of small bowel endoscopy.Complete enteroscopy was choosen as study endpoint, because it is the mostobjective parameter. DBE was considered to reach more than double a completeenteroscopy compared to SBE (40% versus 15%). Number of patients needed to beinvestigated for this hypothesis was calculated with 98 randomised patients. Onlydiagnostic or therapeutic examinations with argon plasma coagulation up to 5angiodysplasias were included. Patients with prior colon and small bowel surgeryhad been excluded. Material and Methods: 117 pats. had been enrolled into thestudy, after exclusion of 17 patients (e.g. due to tumor stenosis, necessarytherapeutic interventions etc.) 100 pats. (50 for each group) (63 male, 37 female)

Vo

with a mean age of 55 years finished the study successfully. Reason for small bowelendoscopy had been (suspected) mid GI bleeding (nZ60), (suspected) Crohn’sdisease (nZ 12), suspected small bowel masses (nZ7) and others (nZ21). Forsmall bowel endoscopy the Fujinon device (EN450-P5) was used either with two orwith one balloon. Results: All balloon enteroscopies had been performed withoutsevere complications. The preparation time of the SBE device had beensignificantly (p!0.0001) faster compared with the DBE device. There was nosignificant difference regarding the investigation time. Complete enteroscopy wasdone with the DBE device in 66 % (33 patients) either with the oral route alone orwith combination of oral and anal approach, whereas with the SBE device the ratewas significantly (p!0.0001) less with 22% (11 patients, only combination of oraland anal route). The diagnostic yield regarding relevant findings had been 50%using DBE and 42% using SBE. Not included in this diagnostic yield rate are thenormal examinations for exclusion of relevant findings or determination of theextension of a known disease, where only a complete small bowel endoscopy cangive this important information. Conclusion: With the DBE technique the rate ofcomplete enteroscopy had been approximately three fold higher than with the SBEtechnique going along with a higher diagnostic yield. Therefore DBE must continueto be regarded as the gold standard procedure for deep small bowel endoscopy.

916

Severe Complications of Spiral Enteroscopy in the First 1750

PatientsPaul A. Akerman, Daniel CanteroSerious complications of deep small bowel enteroscopy occur infrequently. Inpublished series, severe complications occur in deep small bowel enteroscopy in0.3 to 4% of cases. The aim of this study is to publish all recognized seriouscomplications occuring during spiral enteroscopy. Patients, Methods, and Materials:There were 1750 patients who underwent spiral enteroscopy from August,2005until November 2008. Cases have been performed in North America and Europe.Data was collected from device representatives and a survey of device users. Thedevice used in all cases was the Discovery SB which is 118 cm long with a hollowspiral 5.5 mm high and 22 cm long with a scope coupler on the proximal end. TheDiscovery SB has an outer diameter of 16 mm and an internal diameter of 9.8 mm.The enteroscopes used in the examinations were 9.2 mm Olympus SIF-180 and 9.4mm Fujinon EN450T-5 200 cm enteroscopes. Severe complications were defined aspancreatitis, nontransient intussusception, severe pain after the procedurerequiring admission to the hospital, bleeding requiring transfusion or admission tothe hospital, cardio-pulmonary arrest during a procedure and perforation. Results:There were no reported complications of pancreatitis, esophageal or gastricperforations, severe bleeding requiring transfusion, cardio-pulmonary arrests ordeaths during or resulting from the spiral enteroscopy procedures. There were 7severe complications(0.4%) reported as a result of the procedure. Six were smallbowel perforations(0.34%). All were recognized immediately when the scope tipentered the peritoneum. Of these, three small bowel perforations occured in theduodenum and three occurred in the jejunum. All perforations occurred whilepushing to advance the scope through the stationary overtube. None of theperforations occured during therapeutic interventions. None of the perforationsoccurred during rotation of the overtube to pleat the small bowel. Three of theperforations occurred when the experience of the physician was less than 10 cases.One patient experienced severe pain after the procedure and was admitted forobservation. The patient did not require intervention and was later discharged.Conclusion: The overall severe complication rate was 0.4% and a perforation rate of0.34%. All of the perforations were recognized immediately when the scope tipvisualized the peritoneum. Perforations may be minimized by advancing theenteroscope only when the lumen is clearly visualized.

917

Spiral Enteroscopy: Prospective Multicenter U.S. Trial in

Patients with Small Bowel DisordersDouglas Morgan, Bennie R. Upchurch, Peter V. Draganov, KennethF. Binmoeller, Oleh Haluszka, Sreenivasa Jonnalagadda, Patrick Okolo,Ian S. Grimm, Michael V. ChioreanBackground: Deep enteroscopy (DBE, SBE) has revolutionized management ofpatients with mid-small bowel disorders. Spiral enteroscopy(SE) is a novelapproach coupling a standard balloon enteroscope with a spiral overtube. Aims ofthe present study were to determine the performance, yield and safety of SE inpatients with suspected or established small bowel pathology. Methods:Prospective, multicenter study with centralized standard database. Patients referredfor anterograde enteroscopy were eligible. Patients with a history of esophagealstricture, advanced cirrhosis, or coagulopathy were excluded. The depth ofinsertion was measured using a standard algorithm. The mean adjusted diagnosticprocedure time was calculated for all procedures: total time minus therapy time.Results: 148 patients were enrolled at 10 centers in the U.S. with a median age of 68(42% male). Co-morbid conditions were common: CAD 37.4%, CHF 12%, COPD16%, prior abdominal/pelvic surgery 55%. Chronic medication use: ASA 27%,clopidogrel 12%, warfarin 6.3%. Obscure GI bleeding(72%) was the most commonindication, of which 32% were overt and 62% had been transfused within 6 months.

lume 69, No. 5 : 2009 GASTROINTESTINAL ENDOSCOPY AB127

Abstracts

Prior diagnostic evaluations: CE 84% (66% abnormal), EGD 84%, colonoscopy 91%,push enteroscopy 29%, DBE/SBE 12.5%. Spiral enteroscopy beyond the LOT wassuccessful in 96% of procedures. The mean MAC doses: propofol 326mg (median200mg), fentanyl 68mcg, midazolam 3.1mg. The median depth of insertion beyondthe LOTwas 250cm (range 80-600cm), with estimated SB segment depths: jejunum(proximal 6%, middle 12.3%, distal 28.8%) and ileum (proximal 44%, middle 6.2%).The terminal ileum was visualized in 1 subject. The mean total procedure time was45.0 minutes for all procedures, and 35.4 minutes for diagnostic procedures. Theadjusted diagnostic procedure time for all procedures was 34.4 minutes.Fluoroscopy was limited(13%). The diagnostic yield was 65%, of which 48% hadmore than one abnormality. 62.3% of findings were localized beyond the proximaljejunum (35% mid-jejunum, 20% distal jejunum, 7.3% ileum). The most commonfindings: angioectasias (61.5%), inflammation (7.5%), neoplasia (6.8%). APCablation accounted for 64% of interventions. The most common adverse events at24 hours were: sore throat(28.3%), swallowing discomfort(24%), and abdominalbloating/discomfort(19%). There were no serious adverse events (perforation,pancreatitis, ileus, death). Conclusions: Spiral enteroscopy appears to be safe andeffective for evaluation of the small bowel. The procedure duration(35,45 minutes)and depth of insertion (250 cm) compare favorably with other deep enteroscopytechniques(DBE, SBE).

918

Influence of Fluoroscopy On Insertion Depth, Proceeding

Duration and Diagnostic Yield During Double-Balloon

Enteroscopy via the Oral Route: Results of a Prospective

Randomized Trial in 156 PatientsHendrik Manner, Andrea May, Juergen Pohl, Christian EllBackground: In experienced hands, fluoroscopy is not routinely used duringdouble-balloon enteroscopy (DBE) via the oral route. Whether the use offluoroscopy may lead to a higher insertion depth or to a shorter duration ofproceeding, has not yet been investigated in a prospective-randomized trial.Methods: A total of 156 patients (pt; 88 male (56.4%); mean age 56�19yrs) wererandomely assigned to undergo DBE via the oral route either with (group A) orwithout fluoroscopy (group B). In 86/156 pt (55.1%), no diagnosis had been madebefore DBE. 83/156 pt (53.2%) had symptoms of mid-GI bleeding. 21 pt (13.5%)had been diagnosed before DBE to have polyposis syndrome; and 20 pt (12.8%) tohave Crohn’s disease. In the remaining 29 pt, various other diagnoses had beenmade. When, during DBE, no further proceeding could be achieved after trying for20 min, change to fluoroscopy was allowed in group B. Primary target criteria of thestudy were the insertion depth (cm) achieved and the duration of the proceeding(min). Secondary target criterion was the diagnostic yield achieved. A diagnosticyield was deemed to have been achieved if a previously made diagnosis waschanged by DBE, or if a new diagnosis was made. Results: In group A, the meaninsertion depth (284�89 cm, range 70-470) achieved was higher (p!0.05)compared with group B (256�86 cm, range 40-430). The mean duration ofcomplete proceeding to the deepest point of insertion was similar in both groups(group A: 48�19 min, range 15-98; group B: 48�18 min, range 15-105; includingduration after change to fluoroscopy in group B). In 20 pt of group B, the decisionwas made to use fluoroscopy during the examination after no further proceedinghad been achieved during 20 min of trying. Through this, the additional insertiondepth achieved was 28�41 cm (0-110). In group A, the diagnostic yield was 43.6%(34 pt); in group B, it was 46.2% (36 pt; pZn.s.). Conclusions: During double-balloon enteroscopy via the oral route, the use of fluoroscopy is able to provideabout 30 cm of additional insertion depth. Nevertheless, even without fluoroscopy,deep insertion into the small bowel can be achieved in experienced hands withsimilar results for proceeding duration and diagnostic yield.

919

30-Month Follow-Up After Double Balloon Enteroscopy in

Patients with Obscure Gastrointestinal HemorrhageLauren B. Gerson, Sharese Newsom, Andrew S. Ross, Carol E. SemradBackground: Double Balloon Enteroscopy (DBE) is a useful endoscopic modalityfor diagnosis and treatment of small bowel abnormalities responsible for obscuregastrointestinal bleeding. Long-term outcomes after DBE have not been extensivelypublished. Methods: We invited patients who had undergone DBE for obscure GIbleeding between 8/04-9/06 to participate. We contacted patients via phone in 11/06and 11/08 in order to collect information regarding recurrent bleeding, need fortransfusions, subsequent procedures, and need for iron therapy since the initialDBE examination. Results: We invited 274 patients to participate in the study;135 (49%) patients agreed to participate with a mean (�SD) age of 64 � 14.8 (range23-90) years. For the first phase of the study, 101 (37%) patients were contactedwith a mean follow-up time post-DBE of 10.5 � 5 (range 2-26) months. The mostcommon findings on DBE examination were AVMs found in 50 (43%) of patientsduring the anterograde approach. Recurrent or persistent anemia occurred in 34(31%) patients: 14 (41%) had persistent anemia requiring transfusions and/or irontherapy, while 20 (59%) had ongoing overt bleeding. In the 32 patients withsubsequent procedures post-DBE, AVMs were found in 8 (25%). Fifty-eight patients

AB128 GASTROINTESTINAL ENDOSCOPY Volume 69, No. 5 : 2009

were subsequently contacted in 11/08 for a mean follow-up of 30 � 7.3(range 18-47)months. The findings from the DBE examinations in these 58 patients includednormal mucosa in 30 (52%), AVMs in 16(27.5%), inflammatory mucosa in 3, andother findings including Dieulafoy lesion (1), blue rubber nevus (1),lymphangiectasia (1), Meckel’s diverticulum (1), ulcerations (3), andparaesophageal hernia (1). Six patients died of causes not related to bleeding.Recurrent bleeding occured in 12/52 (23%). Recurrent bleeding occured in 6patients with normal DBE, 3 with AVMs, and in 4 other patients (1 blue rubbernevus, 1 radiation enteritis, 1 portal hypertensive enteropathy, 1 untreated Crohn’spatient). 5 patients underwent repeat DBE, 4 small bowel resection, 1 surgicalshunt, and 1 valve replacement. 7 patients received transfusions and 12 remainedon iron therapy. Conclusions: 30 months post-DBE for obscure GI bleeding, themajority of patients (67%) who were contacted did not have recurrent bleeding,require transfusions or iron therapy. Patients with normal initial DBE examinationsor AVMs were most likely to experience recurrent bleeding.

920

Findings and Clinical Impact of Primary Balloon Assisted

Enteroscopy in Patients with Obscure Gastrointestinal BleedingMark F. Godeschalk, Peter Mensink, Henk R. Van Buuren, ErnstJ. KuipersBackground: In the diagnostic approach of obscure gastrointestinal bleeding(OGIB) both wireless capsule endoscopy (WCE) and balloon-assisted enteroscopy(BAE) are used. The advantage of the primary WCE approach, eventually followedby targeted BAE, is its non-invasiveness. The main advantage of the primary BAEapproach is the excellent diagnostic accuracy and the possibility to performtreatment during the same procedure. The aim of this study was to evaluate thediagnostic and therapeutic outcome of OGIB patients, following a primary BAEapproach. Methods: A retrospective analysis of our BAE database with patientsevaluated for OGIB was performed. BAE data, findings and follow-up were obtainedand evaluated. All patients had (often repeated) upper endoscopy and (ileo-)colonoscopy before BAE. Results: In 4 years time, in total 470 patients had a BAEprocedure at our institution, of which 170 patients were evaluated for OGIB: 105males, 62 (11-88) years. In 79 (47%) patients a possible cause for OGIB was found inthe small bowel during BAE: vascular malformations in 55 (70%), ulcerative lesionsin 10 (13%), tumors in 4 (5%), and other findings in 10 (12%) patients. In 57 (72%)patients therapy was performed: argon plasma coagulation, surgery or both, inrespectively 50, 3 and 4 patients. Follow-up could be obtained in 134 (79%)patients, mean 20 (1-47) months. Patients were divided into 2 groups: likely causeof OGIB (angiodysplasia, vessel malformations, tumors, Meckel’s diverticulum andulcerations), or no likely cause of OGIB found during BAE; see Table. Of patientstreated for vascular malformations (i.e. angiodysplasia or AV malformations; follow-up was available in 39) 28 (72%) patients had normalisation or improvement ofanemia, in 11 (28%) patients anemia was unresolved. In 14 (36%) patients withinitial improvement after endoscopic therapy, complaints reoccurred, anda repeated BAE with retreatment was performed with clinical success in 8 (57%)patients. Conclusions: A high prevalence of small bowel abnormalities is found witha primary BAE approach in OGIB patients. In patients with a likely cause ofbleeding, therapy seems successful at mid-term follow-up. In selected patientsretreatment deems necessary for total resolution of OGIB. The high frequency ofspontaneous resolution of anemia in patients with no cause found during BAE,suggests that we are in need of a better patient selection.

OGIB pts (with FU; nZ134) Improved Hb Unchanged Hb

www.g

Likely cause (nZ55)

42 (76%) 13 (24%) No likely cause (nZ69) 47 (68%) 22 (32%)

921

A Simple Scoring System Predicts Which Patients with

Esophageal Cancer Benefit from Endoscopic Ultrasound for

Lymph Node ClassficationGregory Zuccaro, Thomas W. Rice, John J. Vargo, John A. Dumot,Tyler Stevens, Rocio LopezBackground: Accurate detection of lymph node (LN) metastases in esophagealcancer (EC) is essential to determine prognosis and guide therapy. EndoscopicUltrasound (EUS) is often used for this purpose, but is costly and operatordependent. Purpose: (1) Develop a simple, non-EUS based scoring system (called‘CEP score’) for LN classification in EC (2) Determine in a subsequent cohort if ‘CEPscore’ can select those EC patients (pts) most likely to benefit from EUS (3) Assessthe contribution of PET scan to LN classification. Methods: Learning set 314 ptswith EC underwent clinical evaluation with endoscopy, followed by esophagectomy.No pt received preop chemoradiotherapy. The gold standard was pathologic LNclassification (pN0Zno LN metastases, pN1ZLN metastases). A logistic regression

iejournal.org