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Endoscopic Ablation of Barrett's Esophagus: A Randomized Trial of Photodynamic Therapy (PDT) Versus Argon Plasma Coagulation (APC)
*W1537 Endoscopic Ablation of Barrett's Esophagus: A Randomized Trial of Photodynamic Therapy (PDT) Versus Argon Plasma Coagulation (APC) Clive J. Kelty, Roger Ackroyd, Nicola J. Brown, Timothy J. Stephenson, Christopher J. Stoddard, Malcolm W. R. Reed Background: Barrett’s esophagus (BE) is the major risk factor for adenocarcinoma of the esophagus, which is increasing in incidence more rapidly than any other cancer in the Western World. BE confers a lifetime risk for developing adenocarcinoma of 10-15%. Both PDT using 5-aminlevulinic acid as a photosensitiser and APC have been shown to be effective in the ablation of BE, but a comparative trial of these two modalities has not been reported. Materials and Methods: Sixty-eight patients (54 male, 14 female; median age 61 years, range 28-81 years) with biopsy proven BE (median length 4cm, range 2-15cm) were randomized to receive PDT (n=34) or APC (n=34). PDT was performed using 5-aminolevulinic acid (ALA) at a dose of 30 mg/kg, followed by laser endoscopy under sedation 4-6 hours later using a windowed balloon applicator and red (635 nm) light at 68 mW/cm2, with a total fluence of 85J/cm2. APC was administered at a gas flow of 2l/min and power setting of 65 W. Multiple treatment sessions (up to a maximum of five) were performed until macroscopic squamous re-epithelialisation was achieved. Endoscopic follow up with 4 quadrant biopsies was performed at 1, 6, 12 and 24 months. Results: All patients in both groups showed a macroscopic reduction in the length of treated BE, with biopsy proven squamous re-epithelialisation. This was greatest in the APC group with 33 of 34 (97%) ablated (median number of treatments 3, range 1-5). In the PDT group complete ablation was achieved in 17 of 34 (50%) (median number of treatments 4, range 1-5). In the remainder, there was a reduction in the length of BE (median reduction 50%, range 5-90%). Buried glands were found in 4 of 17 (24%) of PDT patients, and 7 of 33 (21%) of APC patients. The median follow up is 12 months (range 1-24 months) in both groups. There was one patient with recurrence of BE after 6 months in the PDT group. All patients treated with PDT suffered from transient nausea and vomiting, and there were photosensitivity reactions in 6 patients (17%). Patients treated with APC developed transient odynophagia. One patient developed an esophageal stricture following APC, which required dilatation. There was no other treatment related morbidity. Conclusions: PDT and APC are both effective modalities for ablating BE. PDT requires more equipment and is more costly in the short term. APC appears to be more effective than PDT for ablation of BE, but the impact of both regimes on the development of carcinoma requires larger studies with long-term follow-up.
*W1538 Successful Eradication of Barrett's Mucosa With Argon Coagulation and Acid Suppression: Mid Term Results Emad Y. Rahmani, Omar Nehme, Kathy Arney, Carolyn Turpin Objectives: This report presents our clinical results of argon plasma coagulation (APC) and argon beam coagulation (ABC) in patients with Barrett’s esophagus with and without low grade dysplasia (LGD). Methods: One hundred patients with Barrett’s esophagus including 22 with LGD were treated using argon plasma coagulation (APC; ERBE), and argon beam coagulation (ABC; ConMed). Double dose proton pump inhibitor omeprazole, lansoprazole or esomeprazole were used for 2 months and the dose which is needed to control symptoms thereafter. Patients with Barrett’s longer than 5 cm were treated in a semicircumferential fashion in two sessions. The procedure is repeated every two months until complete endoscopic ablation is achieved. Jumbo biopsies were obtained and examined by a specialized GI pathologist. Patients were followed up for 4-70 months (mean 36 months). Results: Complete re-epithelialization was visualized at endoscopy in 92 patients after 1-4 procedures (mean 2.2). Partial eradication with squamous re-epithelialization was observed in 4 patients. Three patients lost follow up and one patient relapsed 2 years after complete eradication. Histological assessment showed Barrett’s mucosa in apparently eradicated Barrett’s in 4 patients and ‘‘buried Barrett’s’’ in 2 patients. One patient who failed initial treatment developed high grade dysplasia 3 years later and underwent photodynamic therapy which resulted in complete ablation and squamous reepithelialization. Histology from other patients revealed normal squamous epithelium with or without inflammation. Complications include two patients developed subcutaneous and mediastinal emphysema, bleeding requiring transfusion in one patient, fever in two patients, stricture requiring a single dilation in two patients, and pain requiring narcotic for up to one week in 20 patients. Conclusion: Argon coagulation with acid suppression can eradicate Barrett’s mucosa with apparent squamous re-epithelialization in the majority of patients. Relapse is unlikely unless acid suppressive therapy is discontinued. Long term studies is needed to evaluate if such intervention prevent the neoplastic progression of Barrett’s esophagus.
P250
GASTROINTESTINAL ENDOSCOPY
*W1539 Complete Ablation of Porcine Esophageal Epithelium Using a Balloonbased Bipolar Electrode Robert A. Ganz, David S. Utley, Roger Stern, Jerome Jackson, Kenneth P. Batts, Paul Termin Aims: To evaluate the gross and histological effect of a novel, balloon-based bipolar radiofrequency (RF) electrode on porcine esophageal epithelium, and to determine whether complete circumferential ablation can be performed without subsequent stricture formation. Methods: In Phase I, 2-4 circumferential esophageal ablations (3 cm length) were created in each of 19 farm swine (mean 21.3 kg) varying power (60-375 W) and energy density (9.7-29.5 J/cm2). Endoscopy was performed at 2 and 4 weeks to evaluate status of ablation sites. In Phase II, 3 circumferential esophageal ablations (3 cm length) were created in each of 12 farm swine (50-60 kg) varying energy density (5, 8, 10, 12, 15 or 20 J/cm2) at 350 W. All animals underwent endoscopy and sacrifice at 48 hours. Histologic assessment was performed to determine the percent (%) of epithelium removed and ablation depth for each site. Results: In Phase I, low energy density (9.7 and 10.6 J/cm2) produced no strictures at 2 or 4 weeks, while high energy density (>20 J/cm2) produced stricture in every case. In Phase II, 8-20 J/cm2 resulted in complete (100%) ablation of epithelium surface area, whereas 5 J/cm2 eliminated 63%. Low energy density (5 and 8 J/cm2) spared the muscularis mucosae, while 10 J/cm2 injured the muscularis mucosae and preserved the submucosa. Submucosal injury was evident at 12 J/ cm2, while muscularis propria injury and esophageal edema were evident at 15 and 20 J/cm2. Conclusions: Achieving complete circumferential ablation of esophageal epithelium without subsequent stricture formation is possible with this balloonbased bipolar RF electrode. Automated regulation of energy density delivered to the tissue via the novel bipolar electrode array is essential in restricting the depth of injury to the epithelium and lamina propria. Settings of 8-10 J/cm2 had the most favorable results and warrant evaluation for the ablation of intestinal metaplasia in humans.
*W1540 Photodynamic Therapy for Dysplastic Barrett's Esophagus and Early Esophageal Adenocarcinoma Should be First Line Therapy! Emad Y. Rahmani, Carolyn Turpin, Kathy Arney Objective: To evaluate our results using photodynamic therapy (PDT) along with other ablative techniques for the treatment of dysplasia or superficial cancer (T1 N0 M0) in patients with Barrett’s esophagus. Methods: Eighty eight (88) patients including 25 with superficial cancer were treated. Initial evaluation included computed tomography, endoscopic ultrasound (EUS) and occasionally positron emission tomography (PET) scan. Photodynamic therapy is achieved using porfimer sodium and an endoscopic diffuser delivering 630 nm light. Endoscopic mucosal resection was used to excise any raised or polypoid tissue prior to PDT and argon plasma/beam coagulation was used to eradicate residual Barrett’s mucosa without dysplasia or with low grade dysplasia (LGD). Repeat PDT or EMR was used to eradicate residual/recurrent Barrett’s with high grade dysplasia (HGD). Follow up endoscopy was performed at 3, 6, and 12 months and yearly thereafter. Follow up EUS was performed at one year post PDT. Patients were maintained on acid suppressive therapy and were followed for 6-72 months (mean 30 months) Results: Complete eradication of Barrett’ss mucosa and/or superficial neoplasm was documented in 85 patients. Two patients died from progressive disease. One mentally challenged patient with long segment Barrett’s was only downgraded from HGD to no dysplasia without complete eradication of the Barrett’s mucosa. Complications from PDT include symptomatic strictures in 20 patients, photosensitivity in 10 patients, and self limited atrial fibrillation in 2 patients. One patient had immediate bleeding post EMR requiring admission for observation for one day. Conclusions: Endoscopic therapy using PDT along with EMR and argon coagulation appears to eradicate dysplastic Barrett’s and neoplasia. This relatively long-term study further documents the efficacy of endoscopic therapy with favorable morbidity and mortality comparing to other modalities.
VOLUME 59, NO. 5, 2004
*W1538 Successful Eradication of Barrett's Mucosa With Argon Coagulation and Acid Suppression: Mid Term Results Emad Y. Rahmani, Omar Nehme, Kathy Arney, Carolyn Turpin Objectives: This report presents our clinical results of argon plasma coagulation (APC) and argon beam coagulation (ABC) in patients with Barrett’s esophagus with and without low grade dysplasia (LGD). Methods: One hundred patients with Barrett’s esophagus including 22 with LGD were treated using argon plasma coagulation (APC; ERBE), and argon beam coagulation (ABC; ConMed). Double dose proton pump inhibitor omeprazole, lansoprazole or esomeprazole were used for 2 months and the dose which is needed to control symptoms thereafter. Patients with Barrett’s longer than 5 cm were treated in a semicircumferential fashion in two sessions. The procedure is repeated every two months until complete endoscopic ablation is achieved. Jumbo biopsies were obtained and examined by a specialized GI pathologist. Patients were followed up for 4-70 months (mean 36 months). Results: Complete re-epithelialization was visualized at endoscopy in 92 patients after 1-4 procedures (mean 2.2). Partial eradication with squamous re-epithelialization was observed in 4 patients. Three patients lost follow up and one patient relapsed 2 years after complete eradication. Histological assessment showed Barrett’s mucosa in apparently eradicated Barrett’s in 4 patients and ‘‘buried Barrett’s’’ in 2 patients. One patient who failed initial treatment developed high grade dysplasia 3 years later and underwent photodynamic therapy which resulted in complete ablation and squamous reepithelialization. Histology from other patients revealed normal squamous epithelium with or without inflammation. Complications include two patients developed subcutaneous and mediastinal emphysema, bleeding requiring transfusion in one patient, fever in two patients, stricture requiring a single dilation in two patients, and pain requiring narcotic for up to one week in 20 patients. Conclusion: Argon coagulation with acid suppression can eradicate Barrett’s mucosa with apparent squamous re-epithelialization in the majority of patients. Relapse is unlikely unless acid suppressive therapy is discontinued. Long term studies is needed to evaluate if such intervention prevent the neoplastic progression of Barrett’s esophagus.
P250
GASTROINTESTINAL ENDOSCOPY
*W1539 Complete Ablation of Porcine Esophageal Epithelium Using a Balloonbased Bipolar Electrode Robert A. Ganz, David S. Utley, Roger Stern, Jerome Jackson, Kenneth P. Batts, Paul Termin Aims: To evaluate the gross and histological effect of a novel, balloon-based bipolar radiofrequency (RF) electrode on porcine esophageal epithelium, and to determine whether complete circumferential ablation can be performed without subsequent stricture formation. Methods: In Phase I, 2-4 circumferential esophageal ablations (3 cm length) were created in each of 19 farm swine (mean 21.3 kg) varying power (60-375 W) and energy density (9.7-29.5 J/cm2). Endoscopy was performed at 2 and 4 weeks to evaluate status of ablation sites. In Phase II, 3 circumferential esophageal ablations (3 cm length) were created in each of 12 farm swine (50-60 kg) varying energy density (5, 8, 10, 12, 15 or 20 J/cm2) at 350 W. All animals underwent endoscopy and sacrifice at 48 hours. Histologic assessment was performed to determine the percent (%) of epithelium removed and ablation depth for each site. Results: In Phase I, low energy density (9.7 and 10.6 J/cm2) produced no strictures at 2 or 4 weeks, while high energy density (>20 J/cm2) produced stricture in every case. In Phase II, 8-20 J/cm2 resulted in complete (100%) ablation of epithelium surface area, whereas 5 J/cm2 eliminated 63%. Low energy density (5 and 8 J/cm2) spared the muscularis mucosae, while 10 J/cm2 injured the muscularis mucosae and preserved the submucosa. Submucosal injury was evident at 12 J/ cm2, while muscularis propria injury and esophageal edema were evident at 15 and 20 J/cm2. Conclusions: Achieving complete circumferential ablation of esophageal epithelium without subsequent stricture formation is possible with this balloonbased bipolar RF electrode. Automated regulation of energy density delivered to the tissue via the novel bipolar electrode array is essential in restricting the depth of injury to the epithelium and lamina propria. Settings of 8-10 J/cm2 had the most favorable results and warrant evaluation for the ablation of intestinal metaplasia in humans.
*W1540 Photodynamic Therapy for Dysplastic Barrett's Esophagus and Early Esophageal Adenocarcinoma Should be First Line Therapy! Emad Y. Rahmani, Carolyn Turpin, Kathy Arney Objective: To evaluate our results using photodynamic therapy (PDT) along with other ablative techniques for the treatment of dysplasia or superficial cancer (T1 N0 M0) in patients with Barrett’s esophagus. Methods: Eighty eight (88) patients including 25 with superficial cancer were treated. Initial evaluation included computed tomography, endoscopic ultrasound (EUS) and occasionally positron emission tomography (PET) scan. Photodynamic therapy is achieved using porfimer sodium and an endoscopic diffuser delivering 630 nm light. Endoscopic mucosal resection was used to excise any raised or polypoid tissue prior to PDT and argon plasma/beam coagulation was used to eradicate residual Barrett’s mucosa without dysplasia or with low grade dysplasia (LGD). Repeat PDT or EMR was used to eradicate residual/recurrent Barrett’s with high grade dysplasia (HGD). Follow up endoscopy was performed at 3, 6, and 12 months and yearly thereafter. Follow up EUS was performed at one year post PDT. Patients were maintained on acid suppressive therapy and were followed for 6-72 months (mean 30 months) Results: Complete eradication of Barrett’ss mucosa and/or superficial neoplasm was documented in 85 patients. Two patients died from progressive disease. One mentally challenged patient with long segment Barrett’s was only downgraded from HGD to no dysplasia without complete eradication of the Barrett’s mucosa. Complications from PDT include symptomatic strictures in 20 patients, photosensitivity in 10 patients, and self limited atrial fibrillation in 2 patients. One patient had immediate bleeding post EMR requiring admission for observation for one day. Conclusions: Endoscopic therapy using PDT along with EMR and argon coagulation appears to eradicate dysplastic Barrett’s and neoplasia. This relatively long-term study further documents the efficacy of endoscopic therapy with favorable morbidity and mortality comparing to other modalities.
VOLUME 59, NO. 5, 2004