Long-Term Outcome of Patients with Obscure Gastrointestinal Bleeding Investigated By Double Balloon Endoscopy

Long-Term Outcome of Patients with Obscure Gastrointestinal Bleeding Investigated By Double Balloon Endoscopy

Abstracts enrolled into the study. Evolution stents were deployed under fluoroscopic and endoscopic control. Prospective data were collected through ...

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Abstracts

enrolled into the study. Evolution stents were deployed under fluoroscopic and endoscopic control. Prospective data were collected through a dedicated Case Report Form. The gastric outlet obstruction scoring system (GOOSS) was used to grade the patients’ ability to eat. Results: A total of 26 enteral stents were placed in 23 patients. Etiology of the stricture was: pancreatic cancer in 14 (60.8%), gastric cancer in 7 (30.4%), ampullary cancer in 1 (4.3%) and primary duodenal cancer in 1. The site of obstruction was pyloric-duodenal in 7 pts (30.4%), duodenal bulb in 6 (26%), second portion of duodenum in 2 (8.6%), third portion of duodenum in 3 (13%), second and third portion in 5 (21.7%). The median length of the stricture was 5.8þ1.88 cm. Mean duration of procedure was 30þ8.60 minutes. Stent misplacement occurred in 2 patients (8.6%) who were successfully treated by placement of a second stent. In 13 patients the proximal end of the stent extended proximal to the pylorus while in 10 the whole stent was opening with both ends in different portions of the duodenum. No early (within 7 days) or late complications were recorded after a median follow-up of 8.8 weeks (range 2-12 weeks). Twentyone patients (91.3%) were able to tolerate oral intake with a significant improvement of GOSS score (from 0.8þ0.26 to 2.6þ0.44). One patient with no symptomatic relief underwent gastrojejunostomy 3 weeks after stenting. Two patients died during follow-up period due to disease progression. Conclusions: The new, double flared Evolution duodenal stent provided in this preliminary evaluation a safe and effective palliation of malignant gastric outlet obstruction. A larger study with longer follow-up is required to confirm these promising preliminary results.

S1522 Usefulness of Bowel Preparation Using Polyethylene Glycol Electrolyte Lavage Solution Three Hours Before Capsule Endoscopy Sadaharu Nouda, Eijiro Morita, Mitsuyuki Murano, Akira Imoto, Takanori Kuramoto, Takuya Inoue, Naoko Murano, Ken Toshina, Eiji Umegaki, Kazuhide Higuchi Background: In some cases observation of target sites is very poor because of residual substances, and so on, at the time of capsule endoscopy(CE). However, the usefulness of a bowel preparation method has not been established to date. Herein, we examined the usefulness of a preparation comprised of polyethylene glycol electrolyte lavage solution (PEG) at the time of CE. Patients: The subjects were 40 patients (25 men and 15 women, ranging in age from 17 - 84 years), in whom CE was performed during the period from September 2005 to September 2007 at our institution. Methods: This was a prospective, randomized and controlled study. CE was performed following a 12-hour fast. The patients were randomized into two groups. The first 20 patients (Group A) received no preparation and the other 20 patients (Group B) received 1L of PEG with 200 mg of dimethylpolysiloxane three hours before CE. Four investigators, blinded as to which group received the preparation, independently evaluated the CE images. As the method of evaluation, the small intestine observation time was divided into two parts: the first half and the second half. Next, a four-step evaluation (4: Excellent to 1: Poor) was performed for items pertaining to residual substances and air bubbles in the first and second observation periods. Moreover, this four-step evaluation procedure was also performed for the overall effect of the preparation. The usefulness of the preparation was compared between the two groups to detect any statistically significant differences. Results: There were no significant differences in patient background factors between the two groups. The results for the first half of the observation period were as follows: residual substances (Group A; median 3.13 [IQR 0.88] vs Group B; 3.50 [0.50]; (PZ0.14)) and air bubbles (Group A; 3.25 [1.25] vs Group B; 3.75 [0.50]; (PZ0.0038)). In the second half of the observation period, the following results were obtained: residual substances (Group A; 2.38 [1.25] vs Group B; 3.00 [0.75]; (PZ0.0087)) and air bubbles (Group A; 2.88 [0.88] vs Group B; 3.50 [0.75]; (PZ0.0011)). The overall effects of the preparation showed a statistically significant difference between the two groups (Group A; 2.50 [1.00] vs Group B; 3.50 [0.63]; (PZ0.0003)). Conclusions: Bowel preparation using 1L of PEG with 200 mg of dimethylpolysiloxane three hours before CE significantly improved residual substances and air bubbles, and can therefore be regarded as useful.

S1523 Overtube-Assisted ERCP in Patients with Surgically Altered Anatomy: A Single Center One-Year Experience Sanjay R. Hegde, Sharon Downey, Kevan Iffrig, Stephen J. Heller, Jeffrey L. Tokar, Oleh Haluszka Introduction: Conventional ERCP in patients with Roux-en-Y and post-Whipple anatomy is technically challenging and in some cases not feasible. Overtube-assisted techniques including double-balloon ERCP (DB ERCP) and Spirus overtube-assisted ERCP (Spirus ERCP) using a forward-viewing enteroscope can allow for deep intubation of the afferent limb facilitating pancreatico-biliary intervention in these patients. Aim: To assess the efficacy and safety of overtube-assisted ERCP in patients with surgically altered anatomy. Methods: Retrospective review of our single center experience with overtube-assisted ERCP procedures in patients with altered surgical anatomy (Roux-en-Y or post-Whipple) between March 2007 and October 2008. Results: A total of 13 patients (7 female) and 21 procedures were identified. Within

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this group, 13 patients had DB ERCP (18 procedures) and 3 patients had Spirus ERCP (3 procedures) performed. Post-surgical anatomy included Roux-en-Y gastric bypass (8 patients), Whipple (2 patients), Roux-en-Y partial gastrectomy (1 patient), Roux-enY post-orthotopic liver transplant (1 patient), and pylorus-preserving Whipple (1 patient). Successful selective cannulation of the duct of interest was achieved in 12/21 cases (57.1%). A total of 20 procedures required therapeutic intervention. Among these cases, a successful therapeutic result was achieved in 12/20 cases (60%). Spirus ERCP was performed in 2 patients who had a prior failed DB ERCP. A comparison of Spirus ERCP and DB ERCP is shown below. Successful selective cannulation and therapeutic intervention were achieved in all 3 Spirus ERCP cases. Spirus ERCP cases were longer than DB ERCP cases; however, this was not statistically significant (pZ0.39). Complications were seen in 3/21 cases and included one case of post-ERCP pancreatitis (DB ERCP), one case of reversible respiratory compromise (DB ERCP), and one case of non-pancreatitis abdominal pain (Spirus ERCP). There were no perforations and no deaths. Conclusion: Overtube-assisted ERCP is feasible and safe in patients with surgically altered anatomy. The use of the Spirus overtube may facilitate pancreatico-biliary intervention in patients that fail DB ERCP. These procedures, while challenging and time consuming, may be facilitated by the development of specifically adapted accessories.

# pts # procedures cannulation success # procedures tx indicated therapeutic success mean procedure time (minutes)

All pts

DB ERCP

Spirus ERCP

13 21 12/21(57.1%) 20 12/20 (60%) 84.3 þ/- 39.4

12 18 10/18(55.6%) 17 10/17 (58.8%) 79.2 þ/- 34.1

3 3 3/3 (100%) 3 3/3 (100%) 116.7þ/- 59

S1524 Yield of Double Balloon Versus Spiral Enteroscopy for Obscure Gastrointestinal Bleeding Drew Schembre, Andrew S. Ross Background: Double balloon (DBE) and spiral (SE) enteroscopy both enable deep intubation of the small bowel via a designated enteroscope combined with a flexible overtube designed to pull, pleat and shorten the small intestine. DBE represents the industry standard, has a high diagnostic yield for obscure gastrointestinal bleeding (OGIB) and facilitates endoscopic therapy. SE is a newer technology that relies on rotation of a threaded overtube rather than a balloon and traction to shorten bowel. SE has not been compared to any other modality. Methods: Patients who underwent antegrade DBE or SE over the 11 month period (January through November, 2008) since SE was introduced at one institution (VMMC) were reviewed. Both DBE and SE were performed with a 2.8 mm channel, 200 cm Fujinon enteroscope. DBE utilized a 145 cm balloon overtube and SE used a 120 cm Spirus Discovery SBÒ threaded overtube. All enteroscopies continued until a convincing bleeding source was identified or forward advancement ceased. Indications, prior capsule results, positive finding, procedure time, therapy and complications were compared. Results: 34 DBE and 23 SE cases were performed via the oral approach during the review period. 24 DBE and 19 SE cases were performed for OGIB of which 18 (75%) DBE and 16 (83%) SE cases had capsule findings which were considered positive for a bleeding source. DBE was technically possible in all patients; 1 SE case failed due to inability to engage the overtube within the jejunum. Median age was 61.5 years for DBE and 68 for SE (pZ0.04). Average procedure time was 77 minutes for DBE and 59 minutes for SE (pZ0.16). A bleeding source was identified at retrograde enteroscopy in 1 of the negative DBE cases and 2 SE cases and these were excluded from yield analysis. Yield for detecting a bleeding source was 70% for DBE and 65% for SE (pZ0.74). Therapy was applied to all SE cases (all AVMs) and to 79% of DBE cases. No complications occurred in either group. 3 patients underwent both DBE and SE during a single session. In one patient, DBE and SE reached the same point at 30 and 35 minutes, respectively. In one patient, the double balloon enteroscope was passed 100cm distal to depth reached by SE but no bleeding source was found. In the third patient, DBE was successfully performed following a failed SE, however no bleeding source was identified. Conclusions: Both DBE and SE facilitate detection and treatment of small bowel bleeding sources in the majority of cases of OGIB. DBE depth may exceed SE, although SE may be somewhat faster than DBE. A randomized trial of both therapies is necessary to determine the relative merits of each technology.

S1525 Long-Term Outcome of Patients with Obscure Gastrointestinal Bleeding Investigated By Double Balloon Endoscopy Satoshi Shinozaki, Hironori Yamamoto, Tomonori Yano, Keijiro Sunada, Tomohiko Miyata, Yoshikazu Hayashi, Masayuki Arashiro, Kentaro Sugano Background and Aims: It is difficult to determine the cause of obscure gastrointestinal bleeding (OGIB). Double balloon endoscopy (DBE) can visualize

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Abstracts

the entire alimentary tract. The aim of this study was to evaluate the diagnostic yield and long-term outcome of patients with OGIB using DBE. Methods: In this retrospective large cohort study, DBE was conducted in 200 consecutive patients with ongoing-overt, previous-overt, or occult OGIB. Follow-up data were available on 151 patients for 29.7 (6-78) months and assessed clinical outcome. We obtained follow-up information from medical records in our institute or from other hospital doctors. Results: DBE detected bleeding sources in 155 of 200 patients (77.5%). The most frequent source detected was small intestinal ulcers/erosions, in 64 patients. The proportion of patients with tumors/polyps in cases of occult OGIB was significantly higher than that in cases of overt OGIB (30%, 9 of 30 patients vs 9%, 16 of 170; p!0.001). Patients who underwent DBE within one month after the last episode of overt bleeding had a better yield of positive findings (84%, 107 of 128 patients vs 57%, 24 of 42: p!0.001). The overall OGIB control rate was 78.1% (118 of 151 patients). Patients with small intestinal vascular lesions had a worse outcome than those with other small intestinal lesions (60%, 18 of 30 patients vs 84%, 59 of 70, p Z 0.02). Large amount of transfusion before DBE and multiple lesions worsened their outcome significantly (p!0.02). Definite bleeding source of vascular lesions showed a shorter rebleeding-free interval than those with suspicious vascular lesions significantly (log-rank test, p Z 0.023). Conclusions: DBE is useful for the diagnosis of patients with OGIB and also provides a good outcome. To maximize the diagnostic yield of DBE for overt bleeding, it should be performed as soon as possible, preferably within one month after bleeding. Patients with small intestinal vascular lesions should be followed more carefully, especially those who require large amounts of transfusion or have multiple lesions.

S1526 Multicenter Clinical Experience of the MiRo Capsule Endoscope Jeong Youp Park, Hee Man Kim, Yun Ah Choi, Tae Joo Jeon, Tae-Hoon Oh, Chang Hoon Kim, Young Hoon Yoon, Seungmin Bang, Hyung Gil Kim, Don Haeng Lee, Yong Woon Shin, SI Young Song Background and Aims: The clinical safety and diagnostic feasibility of the MiRO capsule endoscope (CE) were evaluated in a multicenter clinical trial and reported. It showed a great advance in capsule endoscope technology and diagnostic potential in small bowel diseases. In this study, we analyzed the clinical experience of the MiRO in patients with suspected small bowel diseases to assess its operation time, complete examination rate of small bowel, diagnostic yield, and complication rate. Methods: From June 2007 to August 2008, a total number of 104 patients underwent the CE at 5 hospitals in Korea. Before the CE, all patients received upper endoscopy, colonoscopy, and small bowel series. Bowel preparation for the CE was done with polyethylene glycol 4 liter and simethicone. Indications for CE included obscure gastrointestinal bleeding for 82 patients, suspected inflammatory bowel disease for 17 patients, protein-losing enteropathy for 1 patient, small bowel tumor for 1 patient, and abdominal pain for 3 patients. Results: The average total capsule operation time was 11 hours and 27 minutes (range: 5 hours 18 minutes w 12 hours). The average small bowel transit time was 5 hours and 54 minutes (range: 1 hours 52 minutes w 11 hours and 59 minutes). In 92 (88.5%) out of 104 cases, the CE was able to explore entire small bowel. Capsule retention occurred in 1 case (1.0%). Significant finding which could explain patients’ condition was noted in 48 (58.5%) out of 82 cases with obscure gastrointestinal bleeding, 10 (58.8%) out of 17 cases with suspected inflammatory bowel diseases. Out of 48 cases with significant finding for obscure gastrointestinal bleeding, 33 cases (68.8%) had mucosal lesion, 13 (27.1%) vascular lesion, and 2 (4.2%) tumorous lesion. Out of 10 cases with significant finding for suspected inflammatory bowel diseases, 9 (90.0%) cases had mucosal lesion and 1 (10.0%) tumorous lesion. Conclusion: The MiRo CE was able to explore entire small bowel even in patients with suspected small bowel diseases demonstrating long operation time and low retention rate. It also produced good diagnostic yield in patients with obscure gastrointestinal bleeding and suspected small bowel inflammatory bowel disease.

S1527 Small Bowel Capsule Endoscopy (SBCE) in Patients with Cardiac Pacemakers (CP) or Implantable Cardioverter Defibrillators (ICD): Outcome Analysis Using a Retrospective Chart Review Justin R. Cuschieri, Mohammed N. Osman, Richard C. Wong, Amitabh Chak, Gerard Isenberg Introduction: There is concern that the radio signals which transmit images obtained from SBCE to its external sensory array could interfere with CP or ICD function. This electromagnetic interference (EMI) can potentially put patients at risk of having adverse events, but it is not known if such interference causes clinically relevant manifestations. Similarly, EMI from the CP or ICD can potentially cause loss of images and data from the SBCE. We sought to determine if there were any interactions seen in patients with CP or ICD who have undergone SBCE to date. Methods: We conducted a retrospective study of patients with a CP or an ICD who underwent continuous electrocardiographic (ECG) monitoring for the duration of the SBCE procedure between 2003-present. ICDs had their detections turned off prior to the procedure, and CP sensing and pacing configuration were either kept the same or changed to optimize patient comfort and safety. The capsule imaging

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procedure reports, CP interrogation reports, and ECG telemetry tracings were reviewed. Unexplained undersensing or oversensing and changes in CP and ICD set parameters and alterations in transmitted images, inability to localize the capsule, or changes in the strength of the transmitted signal for SBCE were collected. Results: 20 patients with either a CP or an ICD who had undergone SBCE were identified. On review of each patient’s chart, no adverse events or hemodynamically significant arrhythmias were reported. The majority of ECG abnormalities observed were also found in pre- or post- SBCE ECG tracings and CP behavior appeared to be appropriate. Two patients appeared to have episodes of undersensing by the CP. For each patient, similar findings were documented in ECGs taken outside the time frame of the SBCE and were felt to most likely represent the CP’s response to the presence of low amplitude atrial fibrillatory activity. There were no alterations in CP or ICD set parameters documented per review of interrogation reports. One patient was observed to have a low signal encountered from the capsule resulting in lack of localization, but no images were lost. Conclusions: Capsule-induced EMI of CP or ICD function in patients that undergo capsule endoscopy remains a possibility but there were no clinically relevant adverse effects seen in this 5 year retrospective study. CP-induced interference of SBCE is also possible, but is infrequent and does not result in loss of images transmitted by the capsule.

S1528 Therapeutic Double Balloon Enteroscopy Reduces Transfusion Requirements in the Management of Occult or Obscure Gastrointestinal Bleeding Mark E. Benson, Courtney Barancin, Roberto M. Gamarra, Nalini M. Guda, Sigurdur Einarsson, Anurag Soni, Deepak V. Gopal Introduction: Patients with occult or obscure gastrointestinal (GI) bleeding can be challenging to manage. Double Balloon Enteroscopy (DBE) is a novel procedure enabling therapeutic interventions within most of the small bowel. Further research regarding the clinical impact of these interventions is needed. Aim: To evaluate the impact of therapeutic DBE on packed red blood cell transfusion requirements in patients with occult or obscure GI bleeding. Methods: This is a retrospective review of patients who underwent DBE at two tertiary care centers from 5/07 to 10/08 with a focus on patients who had therapeutic endoscopic interventions for occult or obscure GI bleeding. A Student’s T-test and Chi square analysis were used for comparison of samples with significance considered if the P value was less than 0.05. Results: There were 77 patients, mean age 64 years (14-89), who underwent DBE in the 18 month period. Of the 77 patients, 70 had occult or obscure GI bleeding. Fortyseven (67%) of the 70 patients had endoscopic findings potentially accounting for the blood loss. These small bowel lesions varied in location from the mid-Jejunum to proximal-mid Ileum and were out of reach via standard small bowel enteroscopy or colonoscopy with Ileoscopy. Forty patients had arterio-venous malformations(AVMs), 4 patients had small bowel ulcerations, 1 patient had celiac disease, 1 patient had a bleeding small bowel (mid-Ileum)polyp and 1 patient had bleeding jejunal diverticula. Forty-two (60%) of the 70 patients had therapeutic DBE interventions including argon plasma coagulation (NZ41), hemoclip placement (NZ3) and snare polypectomy (NZ1). Among the patients with therapeutic interventions, there was a statistically significant per patient decrease in the amount of blood units transfused during the preceding 6 months, [mean 1.8 units (range Z 0-20)] compared to the 6 months after the DBE exam, [mean 0.3 units (range Z 0-5)]; (PZ0.04). There were 3 patients who had post procedure GI bleeding within 30 days after therapeutic DBE; all were managed conservatively. This was not significantly higher compared to the group of patients who did not have a therapeutic intervention (P Z 0.17). Conclusions: 1) Therapeutic DBE results in a long-term and clinically significant beneficial outcomes among patients with occult or obscure GI bleeding as noted by a decrease need for red blood cell transfusion requirements. 2) AVMs are the most commonly treated lesion in patients with occult or obscure GI bleeding. 3) Therapeutic DBE is a safe procedure. 4) Gastroenterologists who perform DBE need to be aware of the its potential therapeutic benefits.

S1529 Concordance Between Capsule Endoscopy Findings and Final Diagnosis Stephen Kim, Prashant Kedia, Nuzhat A. Ahmad Background: Capsule endoscopy (CE) has become an important diagnostic tool for small bowel lesions. The indications for its use have continued to expand but its role in patient management and outcomes is unclear. Objectives: The primary outcome was the concordance between CE findings and the final diagnosis in patients undergoing CE for a variety of indications. A secondary outcome was to evaluate the correlation between capsule endoscopy findings and symptom resolution. Methods: All patients who had undergone a CE between January 2005December 2007 at a single institution were included in the study. Data collection on the patients’ medical work-up, diagnoses, treatments, and final outcomes was performed through a retrospective chart review. CE findings were classified as positive, suspicious, or negative based on clinical scenario and associated findings. Final diagnoses were established by confirmation with invasive procedures or presumed on the basis of previously negative work-up or symptom resolution after

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