- Email: [email protected]
Su1486 Locoregional Mitomycin C Injection for Post-Endoscopic Submucosal Dissection Strictures Refractory to Endoscopic Balloon Dilation
Abstracts
manometry was repeated at 6 month follow up. Results: To date 5 patients have underwent TEEM. A circular myotomy was safely accomplished in all. Resolution of dysphagia was reported in the immediate post op period in all patients and at 6 months. The average LES pressure decreased from average of 27.5 mm of Hg prior to the myotomy to average of 10.5 mm of Hg in 2 patients who have reached 6 month follow up. The esophagus remained a peristaltic. Conclusions: A decrease in LES pressure can be documented at 6 months following TEEM. We speculate that the benefits of TEEM are permanent.
Su1484 Prevalence of Barrett’s Esophagus, Dysplasia and Esophageal Adenocarcinoma in a Single Centre in Argentina Mercedes J. Rebay1, Luis Durand1, Cecilio L. Cerisoli1, Pablo C. Rodriguez1, Carolina Bolino1, Santiago De Elizalde2, Boris Elsner3, Alejandra Avagnina4, Luis E. Caro1 1 Gedyt, Buenos Aires, Argentina; 2Laboratorio de Anatomia Patologica, Ciudad Autonoma de Buenos Aires, Argentina; 3Centro de Patologia Dr. Elsner, Ciudad Autonoma de Buenos Aires, Argentina; 4 CEMIC, Ciudad Autonoma de Buenos Aires, Argentina Background: Esophageal adenocarcinoma (EAC), the worst complication of Gastroesophageal Reflux Disease (GERD) and Barrett’s Esophagus (BE), has had an exponential growth in the last four decades. Male gender, white race and age at the time of diagnosis are known risk factors for this disorder. Its correlation with reflux symptoms and whether Intestinal Metaplasia (IM) is a necessary event in the progression of BE to dysplasia and EAC, remain controversial. Objectives: To estimate the prevalence of: 1. BE and type of metaplasia; 2. Dysplasia and EAC in the BE population; 3. Reflux symptoms in these patients. Materials and Methods: 21765 upper endoscopy reports of adults seen at the GI outpatients’ clinic in Buenos Aires city between 2001 and 2009 were reviewed. Patients with endoscopic suspicion of BE and columnar metaplasia confirmed on histology were included. Intestinal Metaplasia (IM) was the criterion for the diagnosis of BE. Data collection to assess symptoms was based on the information provided in the “reason for study indication”. The study design was descriptive, observational, retrospective, and cross sectional. Statistical analysis: VCCSTAT 2.0 Results: 617 patients with endoscopic suspicion of BE were analyzed; 63% were male, average age was 49.5 years (range 14 - 85) and all were white. Columnar metaplasia was confirmed in 586 (95%). Hiatal Hernia and esophagitis were described in 44 and 38% of cases respectively. Other endoscopic findings are described in table 1. Histologic findings included: IM in 46% (283/617), Glandular Metaplasia (GM) in 49%(303/617), and chronic esophagitis in 5%( 31/617) of cases. Prevalence of IM in the selected population was 1.3% (CI 95% 1.2 - 1.5). Prevalence of Low Grade Dysplasia was 3.8% (CI 95% 1.7 - 7), that of High-Grade Dysplasia was 2.5 (CI 95% 0.9 - 5.4) and that of EAC was 2.1% (CI 95% 0.7 - 4.8) in the BE population; none of these findings were reported in the GM group. Table 1 The prevalence of reflux symptoms (table 2) was 41% (95% CI 35-47). However, complications of GERD (42%) were the main indication for the procedure. Table 2 Conclusions: Prevalence of BE, Low and High Grade Dysplasia in our setting is in keeping with data reported in the literature. Dysplasia or EAC were only observed in the IM group. In view of these findings and that complications prompted endoscopy in most cases, implementation of preventive strategies emphasizing the importance of a strict protocol for biopsy collection is imperative. Table 1. Endoscopic findings Endoscopic findings
n
%
Total
Barrett’s Esophagus Union ⬍ 3 cm (short) ⬎ 3 cm (long)
271 238 108
44 38.5 17.5
617
Table 2. Reasons for study indication Indications for Upper endoscopy Symptoms Acidity Heartburn Epigastralgia Regurgitation Complications Control of esophaqitis Surveillance in BE Control of Antireflux surgery Others Total
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n
%
22 74 21 1
7.8 26 7.5 ⫺
18 95 3 49 283
42
17.3 100
Su1485 Increase of Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy for Obesity Chi-Ming Tai, Chih-Kun Huang, Chi-Yang Chang, Shih-Che Huang, Ching-Tai Lee, Jaw-Town Lin E-Da hospital/I-Shou University, Kaohisung, Taiwan Background: Obesity is one of the risk factors for gastroesophageal reflux disease (GERD). Patients with morbid obesity are frequently associated with GERD. Laparoscopic sleeve gastrectomy (LSG) is an effective surgical treatment for morbid obesity. However, patients who received LSG were reported to have more GERD symptoms in spite of significant weight loss postoperatively. Little information is available on chronological changes of GERD symptoms and endoscopic alteration of esophageal mucosa after LSG. Aim: The aim of this study was to prospectively evaluate the chronological changes of GERD symptoms and endoscopic alteration of esophageal mucosa in severely obese patients who underwent LSG. Methods: Forty-seven severely obese Chinese patients who received LSG between August 2007 and June 2009 were enrolled. GERD symptoms were defined as the presence of typical heartburn and/or acid regurgitation at least once weekly in the past three months. The severity of GERD symptoms was assessed by Reflux Disease Questionnaires (RDQ). Erosive esophagitis (EE) was defined as the presence of mucosal break at lower esophagus by esophagogastroduodenoscopy (EGD) and graded as A to D according to Los Angeles (LA) classification. All patients received RDQ and EGD before and at least one year after LSG. Results: Thirty-three women (70.2%) and 14 men (29.8%) were enrolled, with a mean age of 36.2 ⫾ 12.1 years. The mean follow-up period was 13.8 months (range: 12-25 months). After surgery, body mass index, waist circumference and the percentage of coexistent metabolic syndrome decreased significantly (36.9 ⫾ 4.4 vs. 25.6 ⫾ 3.2, 100.6 ⫾ 13.3cm vs. 86.3 ⫾ 10.1cm and 55.3% vs. 10.6%, respectively, all with P ⬍ 0.001). The incidence of GERD symptoms and EE increased significantly after LSG (10.6% vs. 38.3%, P ⫽ 0.002 and 17.0% vs. 61.7%, P ⬍ 0.001, respectively). Specifically, the median (interquartile range) score of RQD increased significantly from 0 (2) to 2 (18) (P⬍0.001). Before surgery, 8 patients (17.0%) were found to have EE by EGD and all were graded as A based on LA classification. After LSG, 29 patients (61.7%) had EE, including 14 (29.8%), 13 (27.7%) and 2 (4.2%) with EE of grade A, B and C, respectively. Conclusions: Although LSG can achieve significant weight loss and improvement of co-morbidities in severely obese Chinese patients, the incidence of GERD symptoms and EE increase after the operation. Moreover, both the severity of GERD symptoms and EE aggravate after LSG.
Su1486 Locoregional Mitomycin C Injection for Post-Endoscopic Submucosal Dissection Strictures Refractory to Endoscopic Balloon Dilation Hiroaki Minamino, Hirohisa Machida, Kazunari Tominaga, Yasuaki Nagami, Masami Nakatani, Satoshi Sugimori, Natsuhiko Kameda, Hirotoshi Okazaki, Hirokazu Yamagami, Tetsuya Tanigawa, Kenji Watanabe, Toshio Watanabe, Yasuhiro Fujiwara, Tetsuo Arakawa Gastroentelogy, Osaka City University Graduate School of Medicine, Osaka, Japan Background and Aim: For a precise pathological examination, endoscopic submucosal dissection (ESD) has been widely used in the cases of superficial esophageal carcinoma (SEC) and is considered as a promising approach for SEC treatment. However, using ESD for lesions with superficial wide extension is challenging because of the high risk of development of severe strictures leading to low quality of life after ESD. Although endoscopic balloon dilation (EBD) is effective for such strictures, it needs to be performed frequently until symptoms such as dysphagia disappear. Mitomycin C (MMC), an antineoplastic agent known to inhibit fibroblastic proliferation and decrease collagen synthesis, is effective in reducing scar formation. Locoregional MMC injection can hence reduce stricture development after EBD. We aimed to clarify the feasibility of locoregional MMC injection for post-ESD strictures refractory to EBD in SEC patients. Patients and methods: The institutional review board approved for 5 scheduled cases in June 2009. Eligibility criteria were as follows: age, 20-75 years; presence of esophageal stricture refractory to repeated EBD; Eastern Cooperative Oncology Group (ECOG) performance status, 0-1; presence/absence of multiple strictures; preserved organs functions; and no severe complications. The procedure, MMC injection followed by EBD was performed as follows. (1) The stricture was dilated using a through-the-scope balloon. (2) Next, 1.5 mL of MMC (1 mg/2 mL) was injected into the lesion in 4 quadrants; absence of leakage was immediately confirmed by esophagram after both EBD and injection. (3) The efficacy was assessed by esophagram, endoscopy, and ingestion at 4 and 8 weeks after the procedure. Ingestion was classified into 5 grades according to the dysphagia score (DS) (Grade 0: can have a normal diet, Grade 1: can tolerate some solid foods, Grade 2: can tolerate semisolids only, Grade 3: can swallow liquids only, and Grade 4: complete dysphagia). (4) The procedure was repeated up to 3 times as required. Results: In August 2010, 5 eligible patients (2 males and 3 females, median age: 70 y) were recruited. The
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GASTROINTESTINAL ENDOSCOPY
AB279
Abstracts
stricture was extended over half the circumference in all the patients after a median of 7 EBDs before MMC was injected. After the procedure, a standard endoscope (diameter, 9.2 mm) could pass through the lesion, and DS was improved in all cases (Grade3¡1 in 3 patients and Grade4¡2 in 2 patients). The procedure was performed once in 2 patients and twice in 3 patients until dysphagia resolved. No serious complications related to the procedure, such as bleeding, perforation, or myelosuppression by the drug, were noted. Conclusion: Locoregional MMC injection for post-ESD strictures refractory to EBD might be feasible even in SEC cases, although an appropriate schedule of the procedure should be established in a mega-study in the future.
Su1487 Prevention of Reflux Using the Retrofit Reflux Control Device in Patients With Distally Placed Esophageal Stents: A Technical Assessment Meike M. Hirdes1, Frank P. Vleggaar1, Hans Ulrich Laasch2, Peter D. Siersema1 1 Gastroenterology & Hepatology, University Medical Center Utrecht, Utrecht, Netherlands; 2Radiology, The Christie NHS Foundation Trust, Manchester, United Kingdom Background: If an esophageal stent is placed through the lower esophageal sphincter (LES), reflux of gastric acid is inevitable and symptoms may be persistent despite high dose proton pump inhibition (PPI). The Retrofit Reflux Control Device (RRCD) is a promising implantable reflux control device, which can be placed inside a previously placed esophageal ‘host’ stent. It is a 35mm long/18 mm wide or 27mm long/23mm wide implantable device that has a tricuspid-type valve, made of a biomimetic polymer custom designed for use in the GI tract, at its midportion. The valve opens at different pressures in each direction. The device intended to prevent gastroesophageal reflux following placement of an esophageal stent, but to allow food passage (without resistance) as well as belching or vomiting. Aim: To evaluate first clinical experience of the Retrofit Reflux Control Device (RRCD). Methods: Between April and October 2010, all patients who had a stent placed through the LES for both benign and malignant strictures had an RRCD inserted after initial placement of the host stent. The RRCD was loaded into the introducer and placed under fluoroscopic guidance over a stiff guide wire in the host stent. Symptoms were assessed every 2 weeks until death or stent removal. PPI was prescribed in case of reflux symptoms. All patients gave informed consent for both host stent and RRCD placement. Results: Ten patients (7 males, median age 60 years, range 53-80) had fully covered metal stents placed for malignant (n⫽5), benign (n⫽4) strictures and severe bile reflux after esophagectomy (n⫽1). Median follow-up period was 3 months (range 1-6). In 5 patients, a 23 mm RRCD was placed in a wide body host stent, in the other 5 patients a 18 mm RRCD was placed in a small body host stent. The upper edge of the host stent was placed at a median of 32 (range 28-34) cm from incisors; the upper edge of the RRCD was placed at a median 36 (range 33-39) cm. Technical success of placement of the RRCD was 100%, complete expansion to the wall of the host stent was confirmed by fluoroscopy. Dysphagia scores improved from a median of 3 (able to swallow liquids) to 1 (able to swallow most solid food) after host stent ⫹ RRCD placement. No reflux or regurgitation symptoms were reported (unless during belching in 1 patient). Although in 1 patient (13%) during repeat endoscopy after 1 month, it was noted
that the RRCD was damaged, most likely due to solid food ingestion, no other incidents of RRCD migration occurred. In 1 patient the host-stent migrated after 1 month with the RRCD still inside, due to healing of the benign stricture. Conclusion: Placement of the RRCD in a host stent was 100% successful. RRCD migration did not occur in any of the RRCD placements. The RRCD can be considered in patients with an esophageal stent placed through the LES to prevent both reflux and regurgitation.
Su1488 Control of Intra-Esophageal pH in Patients With Barrett’s Esophagus on Zegerid (Omeprazole-Sodium Bicarbonate) 40 mg Twice Daily Therapy Lauren B. Gerson1, Shilpa Mitra1, Tohru Sato12, William F. Bleker3, Philip Yeung3 1 Gastroenterology, Stanford University, Stanford, CA; 2 Gastroenterology, VA Palo Alto Health Care System, Palo Alto, CA; 3 Santarus, Inc, San Diego, CA Background: Barrett’s esophagus (BE) occurs in approximately 10% of patients with chronic gastroesophageal reflux disease (GERD). Prior studies have demonstrated that approximately 30-40% of BE patients still manifest abnormal esophageal pH profiles despite adequate control of GERD symptoms with proton pump inhibitor (PPI) therapy; the majority of these patients show inadequate nighttime acid control. The goal of this study was to evaluate control of daytime and nighttime esophageal reflux using 48-hour Bravo pH monitoring in BE patients on Zegerid (IR-OME) 40 mg twice daily (QAM/QHS). Methods: Patients with documented BE with intestinal metaplasia confirmed by biopsy were enrolled. All patients were required to stop their current medical therapy for GERD and undergo 48-hour Bravo pH monitoring off therapy for one week. Patients subsequently received IR-OME therapy subsequently for at least 3 weeks. All patients next underwent repeat Bravo pH testing while on IR-OME therapy. GERD symptoms were assessed by Reflux Disease Questionnaire (RDQ) while off and on IR-OME therapy. Results: Eighty eight patients were screened; 34 patients with BE subsequently declined enrollment. 28 subjects were excluded for the following reasons: lack of BE after review of endoscopy and/or pathology reports (N⫽22), presence of esophageal cancer (1), post-ablative therapy for BE (2), presence of achalasia (2), and asian background (1). 27 patients signed informed consent; 21 patients underwent the first Bravo study off of PPI. 4 patients did not return for a second Bravo study, 2 patients violated protocol and stopped Zegerid prior to the second study. Fifteen patients completed the study [13 male, 2 female; mean (⫾ SD) age 62 ⫾ 9 years; mean body mass index 31 ⫾ 8 kg/m2 (range 23-48); mean BE length of 2.6 ⫾ 2 cm; 9 (43%) patients with long segment BE]. Results from pH monitoring are depicted in the Table. All (100%) patients demonstrated normalization of supine esophageal pH levels on both days of IR-OME therapy. One patient (6%) with 8 cm of BE demonstrated abnormal upright reflux on the second day of monitoring on Zegerid therapy; all of the other patients demonstrated normal pH scores on therapy. IR-OME therapy was well tolerated by all patients without adverse events except for one patient who experienced an unrelated case of diverticulitis. Conclusions: Zegerid 40 mg twice daily (QAM/QHS) demonstrated control of nocturnal esophageal reflux in 100% of BE patients and complete control of esophageal pH during 97% of the 24-hour recording periods.
Results of pH Monitoring off PPI and on IR-OME Therapy*
Off PPI D#1 Off PPI D#2 On IR-OME D#1 On IR-OME D#2
DeMeester
% Time pH<4
% Upright<4
% Supine < 4
Number Reflux
RDQ Regurg**
RDQ Heartburn **
42⫾2 (19-97) 44⫾26 (1-103) 2⫾2 (0-5) 3⫾6 (0-24)
14⫾6% (5-29%) 14⫾7 (3-29) 0.5⫾0.5 (0-1) 0.6⫾2 (0-7)
16⫾6% (7-28%) 15⫾8 (0-33) 0.7⫾0.7 (0-2) 1⫾3 (0-10)
10⫾10% (0-33%) 5⫾10 (0-36) 0.1⫾0.1 (0-0.5) 0.05⫾0.2 (0-10)
82⫾40 (12-176) 70⫾47 (4-173) 9⫾8 (0-22) 8⫾18 (0-72)
8⫾6 (0-18)
10⫾6 (0-18)
3⫾4 (0-11)
0.5⫾2 (0-6)
Values shown are Mean⫾Standard Deviation (Range) *p values ⬍0.001 comparing all values on pH studies on and off PPI therapy and for RDQ scores on and off PPI therapy **Regurg ⫽ regurgitation subscale. Heartburn ⫽questions pertaining to heartburn symptoms
Su1489 Endotherapy of Tracheo-Esophageal Fistulas Under Simultaneous Bronchoscopic Guidance Mihir S. Wagh1, Michael A. Jantz2, Christopher E. Forsmark1 1 Division of Gastroenterology, University of Florida, Gainesville, FL; 2 Division of Pulmonary Medicine, University of Florida, Gainesville, FL Background: Management of tracheo-esophageal fistulas (TEF) involves a multidisciplinary approach with interventional gastroenterology, pulmonology and thoracic surgery. We present a unique approach for the management of TEF with simultaneous upper endoscopy and bronchoscopy. Aim: To assess the feasibility of a combined endoscopic and brochoscopic approach to management
of TE fistulas. Methods: 7 patients with TEF (5 male; mean age 60.7, range 54 82 yrs) underwent simultaneous endoscopy and bronchoscopy (endoscope and bronchoscope inserted at the same time) under conscious sedation to visualize and treat the fistula. Etiology for the TEF included esophageal cancer in 3 patients, laryngeal cancer post surgery and radiation in 1, lymphoma with radiation in 1, erosion from proximal end of previously placed esophageal stent in 2 patients (one with esophageal cancer and the other with mediastinal fibrosarcoma and radiation). Follow-up esophagram or CT scan was obtained to check for closure of the fistula after stent placement. Clinical follow-up was obtained at pulmonary or GI clinics. Results: Fully covered esophageal stents (2 Alimaxx, 3 Wallflex) and Aero tracheal stents were successfully placed under dual scope guidance. An esophageal stent could not be placed in one patient
AB280 GASTROINTESTINAL ENDOSCOPY Volume 73, No. 4S : 2011
www.giejournal.org
manometry was repeated at 6 month follow up. Results: To date 5 patients have underwent TEEM. A circular myotomy was safely accomplished in all. Resolution of dysphagia was reported in the immediate post op period in all patients and at 6 months. The average LES pressure decreased from average of 27.5 mm of Hg prior to the myotomy to average of 10.5 mm of Hg in 2 patients who have reached 6 month follow up. The esophagus remained a peristaltic. Conclusions: A decrease in LES pressure can be documented at 6 months following TEEM. We speculate that the benefits of TEEM are permanent.
Su1484 Prevalence of Barrett’s Esophagus, Dysplasia and Esophageal Adenocarcinoma in a Single Centre in Argentina Mercedes J. Rebay1, Luis Durand1, Cecilio L. Cerisoli1, Pablo C. Rodriguez1, Carolina Bolino1, Santiago De Elizalde2, Boris Elsner3, Alejandra Avagnina4, Luis E. Caro1 1 Gedyt, Buenos Aires, Argentina; 2Laboratorio de Anatomia Patologica, Ciudad Autonoma de Buenos Aires, Argentina; 3Centro de Patologia Dr. Elsner, Ciudad Autonoma de Buenos Aires, Argentina; 4 CEMIC, Ciudad Autonoma de Buenos Aires, Argentina Background: Esophageal adenocarcinoma (EAC), the worst complication of Gastroesophageal Reflux Disease (GERD) and Barrett’s Esophagus (BE), has had an exponential growth in the last four decades. Male gender, white race and age at the time of diagnosis are known risk factors for this disorder. Its correlation with reflux symptoms and whether Intestinal Metaplasia (IM) is a necessary event in the progression of BE to dysplasia and EAC, remain controversial. Objectives: To estimate the prevalence of: 1. BE and type of metaplasia; 2. Dysplasia and EAC in the BE population; 3. Reflux symptoms in these patients. Materials and Methods: 21765 upper endoscopy reports of adults seen at the GI outpatients’ clinic in Buenos Aires city between 2001 and 2009 were reviewed. Patients with endoscopic suspicion of BE and columnar metaplasia confirmed on histology were included. Intestinal Metaplasia (IM) was the criterion for the diagnosis of BE. Data collection to assess symptoms was based on the information provided in the “reason for study indication”. The study design was descriptive, observational, retrospective, and cross sectional. Statistical analysis: VCCSTAT 2.0 Results: 617 patients with endoscopic suspicion of BE were analyzed; 63% were male, average age was 49.5 years (range 14 - 85) and all were white. Columnar metaplasia was confirmed in 586 (95%). Hiatal Hernia and esophagitis were described in 44 and 38% of cases respectively. Other endoscopic findings are described in table 1. Histologic findings included: IM in 46% (283/617), Glandular Metaplasia (GM) in 49%(303/617), and chronic esophagitis in 5%( 31/617) of cases. Prevalence of IM in the selected population was 1.3% (CI 95% 1.2 - 1.5). Prevalence of Low Grade Dysplasia was 3.8% (CI 95% 1.7 - 7), that of High-Grade Dysplasia was 2.5 (CI 95% 0.9 - 5.4) and that of EAC was 2.1% (CI 95% 0.7 - 4.8) in the BE population; none of these findings were reported in the GM group. Table 1 The prevalence of reflux symptoms (table 2) was 41% (95% CI 35-47). However, complications of GERD (42%) were the main indication for the procedure. Table 2 Conclusions: Prevalence of BE, Low and High Grade Dysplasia in our setting is in keeping with data reported in the literature. Dysplasia or EAC were only observed in the IM group. In view of these findings and that complications prompted endoscopy in most cases, implementation of preventive strategies emphasizing the importance of a strict protocol for biopsy collection is imperative. Table 1. Endoscopic findings Endoscopic findings
n
%
Total
Barrett’s Esophagus Union ⬍ 3 cm (short) ⬎ 3 cm (long)
271 238 108
44 38.5 17.5
617
Table 2. Reasons for study indication Indications for Upper endoscopy Symptoms Acidity Heartburn Epigastralgia Regurgitation Complications Control of esophaqitis Surveillance in BE Control of Antireflux surgery Others Total
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n
%
22 74 21 1
7.8 26 7.5 ⫺
18 95 3 49 283
42
17.3 100
Su1485 Increase of Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy for Obesity Chi-Ming Tai, Chih-Kun Huang, Chi-Yang Chang, Shih-Che Huang, Ching-Tai Lee, Jaw-Town Lin E-Da hospital/I-Shou University, Kaohisung, Taiwan Background: Obesity is one of the risk factors for gastroesophageal reflux disease (GERD). Patients with morbid obesity are frequently associated with GERD. Laparoscopic sleeve gastrectomy (LSG) is an effective surgical treatment for morbid obesity. However, patients who received LSG were reported to have more GERD symptoms in spite of significant weight loss postoperatively. Little information is available on chronological changes of GERD symptoms and endoscopic alteration of esophageal mucosa after LSG. Aim: The aim of this study was to prospectively evaluate the chronological changes of GERD symptoms and endoscopic alteration of esophageal mucosa in severely obese patients who underwent LSG. Methods: Forty-seven severely obese Chinese patients who received LSG between August 2007 and June 2009 were enrolled. GERD symptoms were defined as the presence of typical heartburn and/or acid regurgitation at least once weekly in the past three months. The severity of GERD symptoms was assessed by Reflux Disease Questionnaires (RDQ). Erosive esophagitis (EE) was defined as the presence of mucosal break at lower esophagus by esophagogastroduodenoscopy (EGD) and graded as A to D according to Los Angeles (LA) classification. All patients received RDQ and EGD before and at least one year after LSG. Results: Thirty-three women (70.2%) and 14 men (29.8%) were enrolled, with a mean age of 36.2 ⫾ 12.1 years. The mean follow-up period was 13.8 months (range: 12-25 months). After surgery, body mass index, waist circumference and the percentage of coexistent metabolic syndrome decreased significantly (36.9 ⫾ 4.4 vs. 25.6 ⫾ 3.2, 100.6 ⫾ 13.3cm vs. 86.3 ⫾ 10.1cm and 55.3% vs. 10.6%, respectively, all with P ⬍ 0.001). The incidence of GERD symptoms and EE increased significantly after LSG (10.6% vs. 38.3%, P ⫽ 0.002 and 17.0% vs. 61.7%, P ⬍ 0.001, respectively). Specifically, the median (interquartile range) score of RQD increased significantly from 0 (2) to 2 (18) (P⬍0.001). Before surgery, 8 patients (17.0%) were found to have EE by EGD and all were graded as A based on LA classification. After LSG, 29 patients (61.7%) had EE, including 14 (29.8%), 13 (27.7%) and 2 (4.2%) with EE of grade A, B and C, respectively. Conclusions: Although LSG can achieve significant weight loss and improvement of co-morbidities in severely obese Chinese patients, the incidence of GERD symptoms and EE increase after the operation. Moreover, both the severity of GERD symptoms and EE aggravate after LSG.
Su1486 Locoregional Mitomycin C Injection for Post-Endoscopic Submucosal Dissection Strictures Refractory to Endoscopic Balloon Dilation Hiroaki Minamino, Hirohisa Machida, Kazunari Tominaga, Yasuaki Nagami, Masami Nakatani, Satoshi Sugimori, Natsuhiko Kameda, Hirotoshi Okazaki, Hirokazu Yamagami, Tetsuya Tanigawa, Kenji Watanabe, Toshio Watanabe, Yasuhiro Fujiwara, Tetsuo Arakawa Gastroentelogy, Osaka City University Graduate School of Medicine, Osaka, Japan Background and Aim: For a precise pathological examination, endoscopic submucosal dissection (ESD) has been widely used in the cases of superficial esophageal carcinoma (SEC) and is considered as a promising approach for SEC treatment. However, using ESD for lesions with superficial wide extension is challenging because of the high risk of development of severe strictures leading to low quality of life after ESD. Although endoscopic balloon dilation (EBD) is effective for such strictures, it needs to be performed frequently until symptoms such as dysphagia disappear. Mitomycin C (MMC), an antineoplastic agent known to inhibit fibroblastic proliferation and decrease collagen synthesis, is effective in reducing scar formation. Locoregional MMC injection can hence reduce stricture development after EBD. We aimed to clarify the feasibility of locoregional MMC injection for post-ESD strictures refractory to EBD in SEC patients. Patients and methods: The institutional review board approved for 5 scheduled cases in June 2009. Eligibility criteria were as follows: age, 20-75 years; presence of esophageal stricture refractory to repeated EBD; Eastern Cooperative Oncology Group (ECOG) performance status, 0-1; presence/absence of multiple strictures; preserved organs functions; and no severe complications. The procedure, MMC injection followed by EBD was performed as follows. (1) The stricture was dilated using a through-the-scope balloon. (2) Next, 1.5 mL of MMC (1 mg/2 mL) was injected into the lesion in 4 quadrants; absence of leakage was immediately confirmed by esophagram after both EBD and injection. (3) The efficacy was assessed by esophagram, endoscopy, and ingestion at 4 and 8 weeks after the procedure. Ingestion was classified into 5 grades according to the dysphagia score (DS) (Grade 0: can have a normal diet, Grade 1: can tolerate some solid foods, Grade 2: can tolerate semisolids only, Grade 3: can swallow liquids only, and Grade 4: complete dysphagia). (4) The procedure was repeated up to 3 times as required. Results: In August 2010, 5 eligible patients (2 males and 3 females, median age: 70 y) were recruited. The
Volume 73, No. 4S : 2011
GASTROINTESTINAL ENDOSCOPY
AB279
Abstracts
stricture was extended over half the circumference in all the patients after a median of 7 EBDs before MMC was injected. After the procedure, a standard endoscope (diameter, 9.2 mm) could pass through the lesion, and DS was improved in all cases (Grade3¡1 in 3 patients and Grade4¡2 in 2 patients). The procedure was performed once in 2 patients and twice in 3 patients until dysphagia resolved. No serious complications related to the procedure, such as bleeding, perforation, or myelosuppression by the drug, were noted. Conclusion: Locoregional MMC injection for post-ESD strictures refractory to EBD might be feasible even in SEC cases, although an appropriate schedule of the procedure should be established in a mega-study in the future.
Su1487 Prevention of Reflux Using the Retrofit Reflux Control Device in Patients With Distally Placed Esophageal Stents: A Technical Assessment Meike M. Hirdes1, Frank P. Vleggaar1, Hans Ulrich Laasch2, Peter D. Siersema1 1 Gastroenterology & Hepatology, University Medical Center Utrecht, Utrecht, Netherlands; 2Radiology, The Christie NHS Foundation Trust, Manchester, United Kingdom Background: If an esophageal stent is placed through the lower esophageal sphincter (LES), reflux of gastric acid is inevitable and symptoms may be persistent despite high dose proton pump inhibition (PPI). The Retrofit Reflux Control Device (RRCD) is a promising implantable reflux control device, which can be placed inside a previously placed esophageal ‘host’ stent. It is a 35mm long/18 mm wide or 27mm long/23mm wide implantable device that has a tricuspid-type valve, made of a biomimetic polymer custom designed for use in the GI tract, at its midportion. The valve opens at different pressures in each direction. The device intended to prevent gastroesophageal reflux following placement of an esophageal stent, but to allow food passage (without resistance) as well as belching or vomiting. Aim: To evaluate first clinical experience of the Retrofit Reflux Control Device (RRCD). Methods: Between April and October 2010, all patients who had a stent placed through the LES for both benign and malignant strictures had an RRCD inserted after initial placement of the host stent. The RRCD was loaded into the introducer and placed under fluoroscopic guidance over a stiff guide wire in the host stent. Symptoms were assessed every 2 weeks until death or stent removal. PPI was prescribed in case of reflux symptoms. All patients gave informed consent for both host stent and RRCD placement. Results: Ten patients (7 males, median age 60 years, range 53-80) had fully covered metal stents placed for malignant (n⫽5), benign (n⫽4) strictures and severe bile reflux after esophagectomy (n⫽1). Median follow-up period was 3 months (range 1-6). In 5 patients, a 23 mm RRCD was placed in a wide body host stent, in the other 5 patients a 18 mm RRCD was placed in a small body host stent. The upper edge of the host stent was placed at a median of 32 (range 28-34) cm from incisors; the upper edge of the RRCD was placed at a median 36 (range 33-39) cm. Technical success of placement of the RRCD was 100%, complete expansion to the wall of the host stent was confirmed by fluoroscopy. Dysphagia scores improved from a median of 3 (able to swallow liquids) to 1 (able to swallow most solid food) after host stent ⫹ RRCD placement. No reflux or regurgitation symptoms were reported (unless during belching in 1 patient). Although in 1 patient (13%) during repeat endoscopy after 1 month, it was noted
that the RRCD was damaged, most likely due to solid food ingestion, no other incidents of RRCD migration occurred. In 1 patient the host-stent migrated after 1 month with the RRCD still inside, due to healing of the benign stricture. Conclusion: Placement of the RRCD in a host stent was 100% successful. RRCD migration did not occur in any of the RRCD placements. The RRCD can be considered in patients with an esophageal stent placed through the LES to prevent both reflux and regurgitation.
Su1488 Control of Intra-Esophageal pH in Patients With Barrett’s Esophagus on Zegerid (Omeprazole-Sodium Bicarbonate) 40 mg Twice Daily Therapy Lauren B. Gerson1, Shilpa Mitra1, Tohru Sato12, William F. Bleker3, Philip Yeung3 1 Gastroenterology, Stanford University, Stanford, CA; 2 Gastroenterology, VA Palo Alto Health Care System, Palo Alto, CA; 3 Santarus, Inc, San Diego, CA Background: Barrett’s esophagus (BE) occurs in approximately 10% of patients with chronic gastroesophageal reflux disease (GERD). Prior studies have demonstrated that approximately 30-40% of BE patients still manifest abnormal esophageal pH profiles despite adequate control of GERD symptoms with proton pump inhibitor (PPI) therapy; the majority of these patients show inadequate nighttime acid control. The goal of this study was to evaluate control of daytime and nighttime esophageal reflux using 48-hour Bravo pH monitoring in BE patients on Zegerid (IR-OME) 40 mg twice daily (QAM/QHS). Methods: Patients with documented BE with intestinal metaplasia confirmed by biopsy were enrolled. All patients were required to stop their current medical therapy for GERD and undergo 48-hour Bravo pH monitoring off therapy for one week. Patients subsequently received IR-OME therapy subsequently for at least 3 weeks. All patients next underwent repeat Bravo pH testing while on IR-OME therapy. GERD symptoms were assessed by Reflux Disease Questionnaire (RDQ) while off and on IR-OME therapy. Results: Eighty eight patients were screened; 34 patients with BE subsequently declined enrollment. 28 subjects were excluded for the following reasons: lack of BE after review of endoscopy and/or pathology reports (N⫽22), presence of esophageal cancer (1), post-ablative therapy for BE (2), presence of achalasia (2), and asian background (1). 27 patients signed informed consent; 21 patients underwent the first Bravo study off of PPI. 4 patients did not return for a second Bravo study, 2 patients violated protocol and stopped Zegerid prior to the second study. Fifteen patients completed the study [13 male, 2 female; mean (⫾ SD) age 62 ⫾ 9 years; mean body mass index 31 ⫾ 8 kg/m2 (range 23-48); mean BE length of 2.6 ⫾ 2 cm; 9 (43%) patients with long segment BE]. Results from pH monitoring are depicted in the Table. All (100%) patients demonstrated normalization of supine esophageal pH levels on both days of IR-OME therapy. One patient (6%) with 8 cm of BE demonstrated abnormal upright reflux on the second day of monitoring on Zegerid therapy; all of the other patients demonstrated normal pH scores on therapy. IR-OME therapy was well tolerated by all patients without adverse events except for one patient who experienced an unrelated case of diverticulitis. Conclusions: Zegerid 40 mg twice daily (QAM/QHS) demonstrated control of nocturnal esophageal reflux in 100% of BE patients and complete control of esophageal pH during 97% of the 24-hour recording periods.
Results of pH Monitoring off PPI and on IR-OME Therapy*
Off PPI D#1 Off PPI D#2 On IR-OME D#1 On IR-OME D#2
DeMeester
% Time pH<4
% Upright<4
% Supine < 4
Number Reflux
RDQ Regurg**
RDQ Heartburn **
42⫾2 (19-97) 44⫾26 (1-103) 2⫾2 (0-5) 3⫾6 (0-24)
14⫾6% (5-29%) 14⫾7 (3-29) 0.5⫾0.5 (0-1) 0.6⫾2 (0-7)
16⫾6% (7-28%) 15⫾8 (0-33) 0.7⫾0.7 (0-2) 1⫾3 (0-10)
10⫾10% (0-33%) 5⫾10 (0-36) 0.1⫾0.1 (0-0.5) 0.05⫾0.2 (0-10)
82⫾40 (12-176) 70⫾47 (4-173) 9⫾8 (0-22) 8⫾18 (0-72)
8⫾6 (0-18)
10⫾6 (0-18)
3⫾4 (0-11)
0.5⫾2 (0-6)
Values shown are Mean⫾Standard Deviation (Range) *p values ⬍0.001 comparing all values on pH studies on and off PPI therapy and for RDQ scores on and off PPI therapy **Regurg ⫽ regurgitation subscale. Heartburn ⫽questions pertaining to heartburn symptoms
Su1489 Endotherapy of Tracheo-Esophageal Fistulas Under Simultaneous Bronchoscopic Guidance Mihir S. Wagh1, Michael A. Jantz2, Christopher E. Forsmark1 1 Division of Gastroenterology, University of Florida, Gainesville, FL; 2 Division of Pulmonary Medicine, University of Florida, Gainesville, FL Background: Management of tracheo-esophageal fistulas (TEF) involves a multidisciplinary approach with interventional gastroenterology, pulmonology and thoracic surgery. We present a unique approach for the management of TEF with simultaneous upper endoscopy and bronchoscopy. Aim: To assess the feasibility of a combined endoscopic and brochoscopic approach to management
of TE fistulas. Methods: 7 patients with TEF (5 male; mean age 60.7, range 54 82 yrs) underwent simultaneous endoscopy and bronchoscopy (endoscope and bronchoscope inserted at the same time) under conscious sedation to visualize and treat the fistula. Etiology for the TEF included esophageal cancer in 3 patients, laryngeal cancer post surgery and radiation in 1, lymphoma with radiation in 1, erosion from proximal end of previously placed esophageal stent in 2 patients (one with esophageal cancer and the other with mediastinal fibrosarcoma and radiation). Follow-up esophagram or CT scan was obtained to check for closure of the fistula after stent placement. Clinical follow-up was obtained at pulmonary or GI clinics. Results: Fully covered esophageal stents (2 Alimaxx, 3 Wallflex) and Aero tracheal stents were successfully placed under dual scope guidance. An esophageal stent could not be placed in one patient
AB280 GASTROINTESTINAL ENDOSCOPY Volume 73, No. 4S : 2011
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