Biodegradable Stents in Refractory Benign Oesophageal Strictures - First Report of 4 Patients from UK

Abstracts

0-IIb esophageal carcinoma underwent ESD. Two cultured autologous oral mucosal epithelial cell sheets were transplanted to the 2/3 circumferential ulceration. Four weeks after ESD, complete healing was observed with no sign of constriction. Conclusions: Based on these findings, it is concluded that this treatment promotes wound healing and prevent inflammation and constriction after EMR/ESD, thereby improves post-operative quality of life of patients.

M1484 Buried Glandular Mucosa After Radiofrequency Ablation of Dysplasia in Barrett’s Esophagus Kenneth E. Fasanella, Alyssa M. Krasinskas, Jon M. Davison, Asif Khalid, Kevin McGrath Background: Radiofrequency ablation (RFA) is an accepted modality for endoscopic treatment of dysplastic Barrett’s esophagus. Neosquamous mucosal ingrowth overlying persistent intestinal metaplasia, known as buried glandular mucosa, or ‘‘buried Barrett’s,’’ has been observed after other endoscopic ablative techniques. However, there have been no reports of this finding in surveillance biopsies after RFA. Methods: We identified all patients treated at our center for Barrett’s esophagus using the HALO ablation system. Patients were excluded if they had been treated with other ablation modalities, or if no follow-up biopsies were available. Seattle protocol biopsies were obtained of the length of treated esophagus between 6 and 12 weeks after the most recent RFA. Biopsies were interpreted by expert pathologists at our institution. Buried glandular mucosa was defined as specialized columnar epithelium beneath a layer of squamous epithelium with no communication with the surface. Follow-up was defined as the time from first RFA treatment to most recent biopsy. All patients were treated with twice daily PPI for at least 6 weeks after RFA. Results: A total of 41 patients were identified and 27 were included in the study. Fourteen patients were excluded due to a history of treatment with other ablation modalities (8) and lack of follow-up pathology (6). The median age was 61 years (interquartile range (IQR); 55, 74) and 70% were male. The median Barrett’s segment length was 2 cm (IQR 0.5, 6). The cohort included 3 patients with non-dysplastic Barrett’s, 5 with low-grade dysplasia (LGD), and 19 with high-grade dysplasia (HGD), 6 of whom also had intramucosal adenocarcinoma. Thirteen of these had undergone EMR prior to RFA. Three underwent circumferential ablation only, 18 underwent focal ablation only, and 6 underwent step-wise circumferential and focal RFA. The median number of treatment sessions was 2 (IQR 1, 2) and median follow-up was 6 months (IQR 5, 11). Buried glandular mucosa was reported in 4 patients (14.8%); 3 of these patients initially had HGD and one had LGD. RFA was repeated in all 4 patients. In one, buried glandular mucosa was not observed on Seattle protocol biopsies on three subsequent occasions. In the others, repeat surveillance biopsies have not yet been obtained. Conclusions: Buried glandular mucosa can be seen in surveillance biopsies after treatment with RFA for dysplastic Barrett’s esophagus. As RFA is well tolerated, patients with this finding can be retreated. The clinical importance of this entity remains to be determined and further follow-up will be necessary to determine clearance rates of these changes.

M1485 Treatment of Malignant Gastro-Duodenal Obstruction Using a Nitinol Self Expanding Metal Stent - An International Prospective Multicenter Experience Guido Costamagna, Andrea Tringali, Julius Spicak, John M. Shaw, Massimiliano Mutignani, Andre Roy, Erik Johnsson, Eduardo Guimara˜es H. De Moura, Spencer Cheng, Thierry Ponchon, Max Bittinger, ´ Laugier, Juha Saarnio, Helmut Messmann, Horst Neuhaus, Rene Francisco Igea Arisqueta Objectives: To document technical and clinical success, and complications associated with use of the WallFlexÔ Duodenal Stent (Boston Scientific Corp, Natick, USA) for the palliative management of malignant gastro-duodenal obstruction per standard of practice in a large international multi-centric experience. Stent performance is documented in the largest prospective series conducted to date. Methods: A web-based registry is conducted at 12 endoscopy centers in 10 countries. Follow-up to 9 months is ongoing. An interim analysis is presented. Results: 202 patients (49% male, mean age 70) were enrolled. Most common causes of the stricture were pancreatic cancer (51%), gastric cancer (18%), and duodenal cancer (10%). Stent length was 9 cm (53%), 6 cm (38%), or 12 cm (9%). Technical success was achieved in 96% (193/202). Gastric Outlet Obstruction (GOO) improved from 14% of patients at Baseline tolerating soft solids or low

AB254 GASTROINTESTINAL ENDOSCOPY Volume 69, No. 5 : 2009

residue/normal diet to 84% at 15 days, 86% at 30 days, 81% at 90 days, and 79% at 180 days. At 90 days post stent placement compared to Baseline, symptoms of postprandial epigastric tenderness, nausea and vomiting improved in 50%, 55% and 69% of patients respectively and did not worsen in 95% for all three symptoms. The most significant complications to date include stent migration (3%), stent fracture (0.5%), perforation (0.5%), cholangitis (1%), pancreatitis (0.5%), and GOO due to tumor ingrowth (10%), tumor overgrowth (3%) or food impaction (2%). Retreatment occurred in 19 patients (13%); 16/19 received another self-expanding metal stent. To date 59% (119/202) patients died, none due to stent or stenting related complications. Conclusion: Preliminary results from this International Registry related to the WallFlexÔ Duodenal Stent, confirm the effectiveness of the endoscopic treatment of GOO with SEMS with acceptable complication profile. Endoscopic re-treatment of malfunctioning (ingrowth/overgrowth) or migrated SEMS is possible.

M1486 Size Matters - SEMS in Pancreatic Necrosis Georg F. Kaehler, Sebastian Belle, Peter H. Collet Background: After H. Seifert proposed endoscopic transgastric debridement many endoscopists carried out pancreatic necrosectomies. Mostly complete cleansing is not achievable in the first session. More than one flap Stent will be changed every session and sometimes the patients need additional rinsing tubes. Methods: Herein we describe the use of a special metallic stent which was designed to keep the pancreaticogastrostomy open in 3 cases. It is a self expanding metal mesh stent with 50 mm length and 20-25 mm diameter. The indication for necrosectomy was made due to infected necrosis in all cases. The decision to use a SEMS was insufficient therapy with flap stents in two cases and visible solid character of the necrosis in the us in the remaining. After establishing of a cystogastrostomy in two cases and one cystoduodenostomy we dilated the cystoenterostomy with a balloon up to 20 mm. Visible and mobile necrotic material was extracted gently with a Dormia basket. Treatment was defined as intervall from implantation of the SEMS until explantation as shown in the table. If no more necrosis was visible the SEMS was removed. Results: In all cases the pancreatic necrosis could be resolved. In a treatment period of 7-8 d with 2-3 endoscopic procedures we achieved clinical success in all cases without major complications. Discussion: In our knowledge this is the first report about the use of metallic stents for transgastric necrosectomy of the pancreas. We conclude from this observation that SEMS promosing new tool. It seems to us that SEMS accelerate healing and are more convenient to the patient.

onset to Age therapy Indication

Treatment period complication

65 73

59 d 144 d

infected necrosis infected necrosis

7d 8d

42

791

infected necrosis/ pain

7d

Endoscopic sessions

none transitory gastric outlet obstruction none

3 3

2

M1487 Biodegradable Stents in Refractory Benign Oesophageal Strictures - First Report of 4 Patients from UK Anjan Dhar, Joanne H. Topping, Emma Johns, Denise O’Neill Introduction: Benign peptic strictures can sometimes be refractory to endoscopic dilatations, with patients requiring frequent dilatations, with risk of complications. These patients have no other option for management except for surgery. Self expanding plastic stents (SEPS) have been anecdotally used in some patients with a high incidence of migration leading to stent removal. Polydioxanone biodegradable stents have recently been introduced in the UK and this is a report of

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Abstracts

their use in the first 4 patients in the North East of England. Aims and Methods: This pilot was carried out with the primary aim of assessing the feasibility of the Ella BDÒ Polydioxanone stent (Ella-CS, Kralove, Czech Republic) in oesophageal dilatation in 4 patients with refractory benign oesophageal stricture. Secondary aims were to assess ease of insertion and placement, patient comfort, migration rates, disintegration times, dysphagia scores at 3 month intervals and complications if any.4 patients with refractory benign oesophageal stricture, defined as symptomatic dysphagiaOGrade2 despite endoscopic dilatation to 15mm in the previous 6 months or requiring more than 3 dilatation sessions over the previous 12 months were offered the Ella BDÒ stent placement. The stent was placed under fluoroscopic and endoscopic visualisation with conscious sedation. Patients were followed up clinically every 4 weeks and endoscopy carried out at 4-6 weeks intervals to assess stent disintegration. Dysphagia assessment was done at 3 months post stent disintegration. Results: 1. The Ella BD stent is cumbersome to load onto the delivery device although improvements have been made to the second generation of the stent.2. Stent placement is easy, and the second generation of stents have better radiological visualisation due to circumferential markers.3. 1 patient had moderately severe discomfort after stent placement requiring analgesics over 2 days.4. No displacement reported or seen at endoscopy in 3 patients; 2cm proximal displacement seen in third patient.5. Stent disintegration occurs around 10-12 weeks.6. Follow up range: 4-17 weeks. No need for dilatation in any patient and no recurrence of dysphagia at 3months post disintegration in 2 patients. Conclusion: The Polydioxanone stent is a feasible option for management of refractory benign oesophageal strictures. Its use may be associated with fewer endoscopic procedures and cost reduction. However, design improvements and large studies are needed before they can be part of the management algorithm.

M1488 Prevention of Subsequent Stricture; Circumferential Endoscopic Resection for Wide Spread Squamous Cell Carcinoma in the Esophagus Hitomi Minami, Haruhiro Inoue, Akira Yokoyama, Haruo Ikeda, Shigeharu Hamatani, Shin-Ei Kudo Background: Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) has become more widely accepted as less invasive treatment for early-stage esophageal cancer. However, circumferential mucosal resection has not generally accepted as a standard procedure because of high rate of subsequent stricture. Among 216 cases of EMR or ESD for early esophageal cancer performed in our institution since April 2001, 7.1% of them had near circumferential spreading of neoplasia, still, the cancer invasion depth was limited to superficial mucosal layer. There are some alternative treatments for squamous cell carcinoma of the esophagus including ablation, chemo-radiation and esophagectomy which still lack evidence of their effectiveness for mucosal squamous cell carcinoma and provide no pathological diagnosis. This report also describes about a series of balloon dilation which was performed after circumferential ESD to prevent subsequent stricture. Objective: The purpose of this study is to clarify the feasibility and morbidity of circumferential mucosal resection for esophageal cancer and effectiveness of preventive balloon dilation. Patients and Methods: Nine patients who underwent circumferential esophageal mucosal resection and preventive balloon dilation for superficial esophageal cancer. Mean age was 71 years old (range 59-81). All patients had mucosal squamous cell carcinoma or adenocarcinoma. Since April 2007, preventive balloon dilation was applied with the last 6 patients. In the first consecutive 3 patients, dilation was performed according to the symptom of dysphagia. All cases were successfully prevented from development of severe dysphagia symptom by frequent dilation. In the last 6 patients, dilation was started on the next day of resection. Duration and frequency were 52 to 183 days (mean 116 days) and 17 to 40 times (mean 23.6 times). All the cases were dilated by using Balloon Dilator(18 mm/20 mm, outer diameter). According to the level of stenosis or resistance of dilating balloon, repeated dilation was applied. In all the cases, no recurrent or remnant cancer has been experienced. Discussion: Resultant esophageal stenosis is unavoidable without dilation after esophageal circumferential mucosal resection. The extensive dissection is hard to be popularized because of the difficulty in releasing stenosis once formed. Preventive balloon dilation is required before the area get concrete stenosis which causes persistent dysphagia. Conclusion: Circumferential ESD can be safe and effective option even for circumferential esophageal cancer. In order to avoid consistent stricture, preventive balloon dilation is regarded to be effective.

M1489 Radiofrequency Ablation for the Treatment of Squamous High Grade Dysplasia of the Oesophagus- First Reported Series Jason M. Dunn, Sally Thorpe, Marco Novelli, Stephen G. Bown, Laurence Lovat Introduction: Squamous dysplasia is the precancerous lesion of squamous cell carcinoma (SCC) of the oesophagus. It is rarely diagnosed in the UK, more commonly seen in Asia. A landmark study from China demonstrated rapid progression to cancer; 35% from low grade dysplasia (LGD) to SCC and 75% from

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high grade dysplasia (HGD) to SCC after 3 years. Most patients are referred for chemoradiation. A minimally invasive treatment option is needed. Endoscopic circumferential radiofrequency ablation (RFA) is a new technique that is effective for the eradication of dysplastic columnar lined oesophagus. Aim: Prospective study to assess the safety and efficacy of RFA for the treatment of squamous dysplasia. Methods: Patients were enrolled with squamous HGD confirmed on two occasions by two independent pathologists. Exclusion criteria included the presence of invasive cancer or previous radiotherapy. Patients underwent EUS prior to enrolment, and endoscopic resection (ER) was undertaken on all visible nodules. A four quadrant biopsy series was taken throughout the oesophagus to delineate the extent of dysplasia. Patients received circumferential balloon based RFA using an energy of 12J/cm2. Follow up biopsy series of the treated area was performed at 2, 6 and 12 months. If there was flat residual dysplasia without SCC on biopsy a further circumferential ablation was undertaken. Any raised areas post RFA were removed by ER. All adverse events were recorded. Results: Efficacy: Seven patients underwent RFA between May 2007 - July 2008. All were non surgical candidates. Mean age 71 years (range 47-82 years), 57% male. Mean follow up is 5 months. Median length of treatment area is 9cm (range 5-15cm). One patient is continuing treatment and is not included in analysis. Complete reversal of HGD was achieved in 4/6 (67%) of patients. 3 had RFA alone(median 1 session, range 1-2), 1 had RFA þ ER . 2/6 patients were found to have moderately differentiated SCC at their first follow up post ablation, and are undergoing chemoradiotherapy. Safety: All ablations were under conscious sedation, with one overnight admission for minor bleeding from the treated area, not requiring transfusion. 1 patient developed a stricture post RFA and ER which required a total of 6 dilatations over 4 months. Conclusion: Circumferential RFA appears a safe and effective adjunct to current treatment for squamous HGD in patients who are not suitable for surgical resection. Patients with nodules post RFA may undergo rescue ER with curative intent. This work is supported by the CRUK Experimental Cancer Medicine Centre at UCL and the NIHR Comprehensive Biomedical Research Centre at UCLH.

M1490 Single Balloon Enteroscopy: Initial Experience At a U.S. Tertiary Care Center David J. Frantz, Evan S. Dellon, Ian S. Grimm, Douglas Morgan Background: Single Balloon Enteroscopy (SBE) is a novel deep enteroscopy modality for diagnosis and treatment of disorders of the small bowel. The aim of the study was to examine the performance, yield and safety of the initial experience of SBE at a tertiary care center. Methods: Retrospective review of all SBEs over a 10 month period in 2008. Patient and procedural characteristics were extracted from electronic clinical and endoscopy records. Primary data analysis is presented for anterograde SBEs. Results: Forty-one SBEs were performed, of which 38 were anterograde. The mean age was 62 (42% female), with mean BMI 26. Nearly all patients (97%) were initially referred for obscure GI bleeding. Parallel indications included: capsule endoscopy with mucosal abnormalities (nZ11), Crohn’s disease (nZ3), abdominal pain (nZ2), suspected polyps or neoplasia (nZ3). The mean procedure time was 49 minutes (range 25-105 min), which did not significantly vary based upon procedural experience. The estimated depth of insertion: proximal jejunum (34%), mid-jejunum (45%), distal jejunum (21%). The mean conscious sedation doses: fentanyl dose 133 mcg, midazolam 9 mg. Adjuvant medication mean dosing when utilized: promethazine 16 mg (nZ8), glucagon 0.3 mg (nZ16). General anesthesia was used in 4 cases (11%). The mean recovery time was 64 minutes (range 29-230 min). The SBE diagnostic yield was 47%, with significant findings in 18 patients. Common findings included: angiectasias or bleeding (nZ10), abnormal mucosa or ulceration (nZ7), polyps (nZ1), foreign body (nZ1). The therapeutic yield was 42%, with APC performed in 24% of patients. Additional therapeutic interventions: hemostasis (nZ2), polypectomy (nZ1), dilatation (nZ1), foreign body removal (nZ1). Also, diagnostic biopsies were performed in 24% of subjects, and tattooing in 52%. There were no immediate complications (perforation, pancreatitis, hospitalization, death). The 3 retrograde SBEs successfully evaluated the distal ileum (range 50-70cm), but without significant findings. Conclusions: Single balloon enteroscopy appears to be a safe and efficient method (49 minutes) for examination of the mid-small bowel. The significant therapeutic yield (42%) suggests comparative studies with DBE and Spiral enteroscopy are warranted.

M1491 A Novel Device, the Orbicular Spring with ‘‘Question Mark’’Shaped Clips, Allows the Mucosal Stomach Carcinoma to Be Rolled Up, Making It Easier to Perform Endoscopic Submucosal Dissection Nobuyuki Sakurazawa, Masao Miyashita, Shunji Kato, Teruo Kiyama, Tsutomu Nomura, Hiroshi Makino, Itsuro Fujita, Keiichi Okawa, Mitinobu Umakoshi, Natsuki Seki, Goro Takahashi, Katsuhiko Iwakiri, Takashi Tajiri Background and Aims: Recently, endoscopic submucosal dissection (ESD) has come to be recognized as a valid treatment alternative for mucosal stomach

Volume 69, No. 5 : 2009 GASTROINTESTINAL ENDOSCOPY AB255