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Benign Refractory Esophageal Strictures: Preliminary Results from the BEST (Biodegradable Esophageal STent) Study
Abstracts
cancers in 302 patients by endoscopic resection. Among them, we identified 106 lesions that met our inclusion criteria: (1) lesions measuring 20 mm or more in diameter, (2) tumor invasion depth of m1-sm1 without lymphovascular involvement, (3) histologically proven squamous cell carcinoma, (4) no additional treatment immediately after ER, and (5) follow-up longer than 1 year, with more than two follow-up endoscopies. Patient factors, tumor factors and technical factors were classified into categories. Kaplan-Meier curves were constructed for the analysis of recurrence, and log-rank tests were used to evaluate the statistical significance of differences. In multivariate analysis, the independent factors were determined by Cox’s regression hazard model using patient and tumor factors and treatment method. Results: The study included 57 lesions treated by EMR and 49 lesions treated by ESD. Median tumor size was 30 (20-70) mm. The en bloc resection rates of EMR and ESD were 17.5 % (10/57 lesions) and 93.9 % (46/49 lesions). At a median follow-up of 34 months (range 11-121 months), there were 12 (11.3%) local recurrences, one from ESD group and 11 from EMR group. There was no significant association between local recurrence and age (PZ0.27), gender (PZ0.17), multiple iodine-unstained lesions (PZ0.79), tumor size (PZ0.15), or circumferential spread of tumor (PZ0.054). However, the endoscopic resection method was significantly associated with local recurrence (PZ0.011). In multivariate analysis for local recurrence, endoscopic resection method was an only independent risk factor (hazard ratio, 12.9; 95% confidence interval, 1.6-104.3; PZ0.016). Conclusions: To minimize local recurrence, esophageal squamous cell carcinoma measuring 20 mm or more in diameter should be treated by ESD.
735 Long-Term Outcomes of Endoscopic Submucosal Dissection for Superficial Esophageal Squamous Cell Neoplasms Satoshi Ono, Mitsuhiro Fujishiro, Keiko Niimi, Osamu Goto, Shinya Kodashima, Nobutake Yamamichi, Masao Omata Background: Endoscopic submucosal dissection (ESD) is a novel, promising endoscopic technique for superficial esophageal squamous cell neoplasms (ESCNs). However, long-term outcomes of esophageal ESD have not been elucidated so far. We aimed to assess technical feasibility and long-term outcomes of ESD for ESCNs. Design: Retrospective study from a single institution. Methods: From January 2002 to July 2008, 107 consecutive superficial ESCNs, which were proven as or suspicious of squamous cell carcinoma, in 84 patients were treated by ESD. For the long-term analysis, all the patients were divided into two groups depending on histopathological depth of the main lesion of each patient: A, high grade intraepithelial neoplasm or invasive carcinoma limited to the lamina propria mucosae; B, invasive carcinoma deeper than the lamina propria mucosae. Rates of en bloc resection, complete resection, and complication were evaluated as shortterm outcome. Overall survival, disease-specific survival, and postoperative stricture rate were evaluated as long-term outcome. Results: En bloc and complete resection rates were 100% and 87.9%, respectively. Perforation accompanied with mediastinal emphysema was observed in 4 patients (3.9%). No patient experienced massive bleeding. In the median observation duration of 632 days (range, 8-2358), fifteen patients experienced esophageal benign stricture with dysphagia which was successfully managed by median two sessions (range, 1-20) of balloon dilatation. One patient had local recurrence at the 6th month after ESD. In two patients with m3 carcinomas, distant metastases were observed at the 18th and the 9th month after ESD, respectively. In observation duration, three patients died from esophageal carcinoma. The 5-year disease-specific survival rates of A group and B group were 100% and 84.9%. Conclusion: This long-term follow-up study revealed that ESD could become a curable treatment for superficial ESCNs. ESD can surely play a central role in treatments for ESCNs.
736 Erroneous EGD-Guided Placement of the pH Capsule Is Common - Time to Hold the Applause? Siva Doma, Sushmita Palladugu, Henry P. Parkman, Frank K. Friedenberg Background: Recommended EGD-guided placement of the BravoÒ pH Capsule is 6 cm proximal to the squamocolumnar junction (SCJ). This corresponds to 5 cm above the proximal border of the manometric LES. Accuracy of EGD-guided capsule placement in symptomatic patients has not been studied. Our aim was to determine the accuracy of EGD-guided capsule placement using manometry as the gold-standard. We hypothesized that an EGD prior to placement may alter the LES SCJ relationship. Specifically, air insufflation of the stomach in a confined area may cause temporary proximal migration of the SCJ landmark resulting in capsule misplacement. Methods: We included all patients undergoing high-resolution esophageal manometry on the same day prior to EGD-guided BravoÒ capsule placement between 1/07 and 8/08. A validated conversion factor of 4 cm was subtracted from the manometric nares-proximal border LES distance to calculate mouth-LES distance. Then 5 cm was subtracted to obtain estimated accurate Bravo location (EL) from the mouth. Actual capsule attachment location (AL) from the incisors was obtained from the EGD report. Difference between AL and EL is the error in placement. Accurate placement for AL was defined as placement within 3 cm of the EL. Results: Of nZ161 patients, 14 were excluded because of prior surgery. Of the remaining 147, the mean age was 45.6 16 y and height 65.2 4.8
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in. Accurate placement of the capsule (within 3.0 cm of EL) was seen in only 91/ 147 (62%) patients. In patients with an inaccurate placement it was more often placed too proximal to the EL (52/56 Z92.9% or 35.4% of all patients undergoing capsule placement) rather than too distal (4/56Z7.1%). There was no correlation between height, hiatal hernia, age, gender, endoscopist, or year of placement and median distance of proximal misplacement. Longer esophageal length correlated with proximal misplacement (43.4 3.5 vs. 41.7 3.2 cm; PZ0.02). Considering only those off PPI’s, for the entire group 59.8% had a positive pH study. For the subgroup with inaccurate placement 65% had a positive study. In the accurately placed group it was 56.5%. Conclusions: The gold-standard for identifying the position of the LES is manometry. The endoscopic technique of using the SCJ as a landmark commonly results in inaccurate placement (primarily proximal) of the BravoÒ pH capsule. Overall, 35.4% were placed O 3 cm too proximal to the manometrically-identified LES. Prior EGD with air insufflation may be the cause. Comparison with non-EGD methods needs to be studied prospectively. Surprisingly, misplacement did not effect the % of patients with a positive pH study for our study group.
737 Benign Refractory Esophageal Strictures: Preliminary Results from the BEST (Biodegradable Esophageal STent) Study Alessandro Repici, Frank P. Vleggaar, Alessandra Carlino, Petra G. Van Boeckel, Fabio Romeo, Peter D. Siersema Background and aim: Benign esophageal strictures refractory to standard dilation therapy are a challenging problem. Temporary plastic and metal stenting has been proposed with inconclusive results. We therefore evaluated the safety and efficacy of a new biodegradable stent (BD Ella Stent) for the treatment of refractory benign esophageal strictures. Patients and Methods: 12 patients (6M/6F, mean age 52.4 range 41-78) with benign esophageal strictures (anastomotic (nZ2), post-surgery (nZ1), post-radiotherapy (nZ4), post-caustic ingestion (nZ1), peptic (nZ3) and idiopathic (nZ1) classified as refractory following the Kochman criteria, were treated by placement of a biodegradable BE Ella stent. Strictures were located in the distal esophagus in 6 patients, in the middle in 3 and in the proximal esophagus in 3. The mean number of dilating sessions before stenting was 6.8þ1.6. Patients were followed at regular interval and endoscopy was scheduled at months 1, 2, 3, 6 and afterwards in case of dysphagia recurrence. Pre and post-stenting dysphagia status as well as complications were prospectively collected. Results: Stents were successfully placed in all patients. No early complications occurred. Pre-stenting mean dysphagia score was 2.8þ0.68. At 3 months, stents were endoscopically in place, but partially fragmented in 3/6 patients. Stent migration was observed in 2 patients (17%). One of these patients was treated again by a second biodegradable stent and is still under follow-up and free of dysphagia. The other patient did not require further treatment because of resolution of the stricture and absence of symptoms at the time of migration. Minor bleeding without a significant drop in Hb lwas observed in 1 patient. After a median follow-up of 22 weeks (4-32), mean dysphagia score was 0.25þ0.12 with 10/12 patients free of dysphagia and 2 patients with persistent but mild dysphagia (grade 1in one patients and grade 2 in a second patient). Conclusions: In this preliminary evaluation, the biodegradable stent afforded a significant relief of dysphagia in a small group of patients with refractory benign esophageal strictures. A larger study with longer follow-up is required to validate these results.
738 Complications of Long-Term Esophageal Stenting in the Management of Benign Perforations Nicoline C. Van Heel, Jelle Haringsma, Manon Spaander, Ernst J. Kuipers Background: The standard approach to benign esophageal perforations includes conservative treatment, surgical repair or esophagectomy. Removable selfexpandable metal stents (SEMS) are increasingly used for relief of perforations of the esophagus. In the current cohort study we investigated the clinical value of SEMS placement for non-malignant esophageal defects. Methods: In a prospective single center observational study, 32 consecutive patients were included. Data were collected from a prospective database, operation reports and endoscopy records. To obtain missing information, we contacted the patients, their relatives or their general practitioner. Results: Thirty-two patients (66% male; median age 73 years (range: 13-87 years)) were followed after initial placement of SEMS (median followup 2 years (range 1 day-7 years)). The majority of perforations were iatrogenic (nZ19), other causes included Boerhaave’s syndrome (nZ9), trauma (nZ1), foreign body (nZ1) and anastomotic leakage (nZ2). Three patients received a fully-covered SEMS and 29 patients received a partially-covered SEMS. Placement was technically successful in all patients. Three patients with Boerhaave’s syndrome required an esophagectomy because of immediate stent failure. The overall 90 day mortality rate was 19%. Stent migration occurred in 10 patients after a median of 12 days, requiring stent reposition (nZ4), additional stent insertion (nZ3) stent removal (nZ1), or no intervention (nZ2). Twelve patients required 16 additional stents for either persistent leakage during stent therapy (nZ8) or after SEMS extraction (nZ8). Four patients underwent debridement of an empyema. A total of 31 endoscopic stent extractions were performed. Of these, 21 stent extractions
Volume 69, No. 5 : 2009 GASTROINTESTINAL ENDOSCOPY AB123
cancers in 302 patients by endoscopic resection. Among them, we identified 106 lesions that met our inclusion criteria: (1) lesions measuring 20 mm or more in diameter, (2) tumor invasion depth of m1-sm1 without lymphovascular involvement, (3) histologically proven squamous cell carcinoma, (4) no additional treatment immediately after ER, and (5) follow-up longer than 1 year, with more than two follow-up endoscopies. Patient factors, tumor factors and technical factors were classified into categories. Kaplan-Meier curves were constructed for the analysis of recurrence, and log-rank tests were used to evaluate the statistical significance of differences. In multivariate analysis, the independent factors were determined by Cox’s regression hazard model using patient and tumor factors and treatment method. Results: The study included 57 lesions treated by EMR and 49 lesions treated by ESD. Median tumor size was 30 (20-70) mm. The en bloc resection rates of EMR and ESD were 17.5 % (10/57 lesions) and 93.9 % (46/49 lesions). At a median follow-up of 34 months (range 11-121 months), there were 12 (11.3%) local recurrences, one from ESD group and 11 from EMR group. There was no significant association between local recurrence and age (PZ0.27), gender (PZ0.17), multiple iodine-unstained lesions (PZ0.79), tumor size (PZ0.15), or circumferential spread of tumor (PZ0.054). However, the endoscopic resection method was significantly associated with local recurrence (PZ0.011). In multivariate analysis for local recurrence, endoscopic resection method was an only independent risk factor (hazard ratio, 12.9; 95% confidence interval, 1.6-104.3; PZ0.016). Conclusions: To minimize local recurrence, esophageal squamous cell carcinoma measuring 20 mm or more in diameter should be treated by ESD.
735 Long-Term Outcomes of Endoscopic Submucosal Dissection for Superficial Esophageal Squamous Cell Neoplasms Satoshi Ono, Mitsuhiro Fujishiro, Keiko Niimi, Osamu Goto, Shinya Kodashima, Nobutake Yamamichi, Masao Omata Background: Endoscopic submucosal dissection (ESD) is a novel, promising endoscopic technique for superficial esophageal squamous cell neoplasms (ESCNs). However, long-term outcomes of esophageal ESD have not been elucidated so far. We aimed to assess technical feasibility and long-term outcomes of ESD for ESCNs. Design: Retrospective study from a single institution. Methods: From January 2002 to July 2008, 107 consecutive superficial ESCNs, which were proven as or suspicious of squamous cell carcinoma, in 84 patients were treated by ESD. For the long-term analysis, all the patients were divided into two groups depending on histopathological depth of the main lesion of each patient: A, high grade intraepithelial neoplasm or invasive carcinoma limited to the lamina propria mucosae; B, invasive carcinoma deeper than the lamina propria mucosae. Rates of en bloc resection, complete resection, and complication were evaluated as shortterm outcome. Overall survival, disease-specific survival, and postoperative stricture rate were evaluated as long-term outcome. Results: En bloc and complete resection rates were 100% and 87.9%, respectively. Perforation accompanied with mediastinal emphysema was observed in 4 patients (3.9%). No patient experienced massive bleeding. In the median observation duration of 632 days (range, 8-2358), fifteen patients experienced esophageal benign stricture with dysphagia which was successfully managed by median two sessions (range, 1-20) of balloon dilatation. One patient had local recurrence at the 6th month after ESD. In two patients with m3 carcinomas, distant metastases were observed at the 18th and the 9th month after ESD, respectively. In observation duration, three patients died from esophageal carcinoma. The 5-year disease-specific survival rates of A group and B group were 100% and 84.9%. Conclusion: This long-term follow-up study revealed that ESD could become a curable treatment for superficial ESCNs. ESD can surely play a central role in treatments for ESCNs.
736 Erroneous EGD-Guided Placement of the pH Capsule Is Common - Time to Hold the Applause? Siva Doma, Sushmita Palladugu, Henry P. Parkman, Frank K. Friedenberg Background: Recommended EGD-guided placement of the BravoÒ pH Capsule is 6 cm proximal to the squamocolumnar junction (SCJ). This corresponds to 5 cm above the proximal border of the manometric LES. Accuracy of EGD-guided capsule placement in symptomatic patients has not been studied. Our aim was to determine the accuracy of EGD-guided capsule placement using manometry as the gold-standard. We hypothesized that an EGD prior to placement may alter the LES SCJ relationship. Specifically, air insufflation of the stomach in a confined area may cause temporary proximal migration of the SCJ landmark resulting in capsule misplacement. Methods: We included all patients undergoing high-resolution esophageal manometry on the same day prior to EGD-guided BravoÒ capsule placement between 1/07 and 8/08. A validated conversion factor of 4 cm was subtracted from the manometric nares-proximal border LES distance to calculate mouth-LES distance. Then 5 cm was subtracted to obtain estimated accurate Bravo location (EL) from the mouth. Actual capsule attachment location (AL) from the incisors was obtained from the EGD report. Difference between AL and EL is the error in placement. Accurate placement for AL was defined as placement within 3 cm of the EL. Results: Of nZ161 patients, 14 were excluded because of prior surgery. Of the remaining 147, the mean age was 45.6 16 y and height 65.2 4.8
www.giejournal.org
in. Accurate placement of the capsule (within 3.0 cm of EL) was seen in only 91/ 147 (62%) patients. In patients with an inaccurate placement it was more often placed too proximal to the EL (52/56 Z92.9% or 35.4% of all patients undergoing capsule placement) rather than too distal (4/56Z7.1%). There was no correlation between height, hiatal hernia, age, gender, endoscopist, or year of placement and median distance of proximal misplacement. Longer esophageal length correlated with proximal misplacement (43.4 3.5 vs. 41.7 3.2 cm; PZ0.02). Considering only those off PPI’s, for the entire group 59.8% had a positive pH study. For the subgroup with inaccurate placement 65% had a positive study. In the accurately placed group it was 56.5%. Conclusions: The gold-standard for identifying the position of the LES is manometry. The endoscopic technique of using the SCJ as a landmark commonly results in inaccurate placement (primarily proximal) of the BravoÒ pH capsule. Overall, 35.4% were placed O 3 cm too proximal to the manometrically-identified LES. Prior EGD with air insufflation may be the cause. Comparison with non-EGD methods needs to be studied prospectively. Surprisingly, misplacement did not effect the % of patients with a positive pH study for our study group.
737 Benign Refractory Esophageal Strictures: Preliminary Results from the BEST (Biodegradable Esophageal STent) Study Alessandro Repici, Frank P. Vleggaar, Alessandra Carlino, Petra G. Van Boeckel, Fabio Romeo, Peter D. Siersema Background and aim: Benign esophageal strictures refractory to standard dilation therapy are a challenging problem. Temporary plastic and metal stenting has been proposed with inconclusive results. We therefore evaluated the safety and efficacy of a new biodegradable stent (BD Ella Stent) for the treatment of refractory benign esophageal strictures. Patients and Methods: 12 patients (6M/6F, mean age 52.4 range 41-78) with benign esophageal strictures (anastomotic (nZ2), post-surgery (nZ1), post-radiotherapy (nZ4), post-caustic ingestion (nZ1), peptic (nZ3) and idiopathic (nZ1) classified as refractory following the Kochman criteria, were treated by placement of a biodegradable BE Ella stent. Strictures were located in the distal esophagus in 6 patients, in the middle in 3 and in the proximal esophagus in 3. The mean number of dilating sessions before stenting was 6.8þ1.6. Patients were followed at regular interval and endoscopy was scheduled at months 1, 2, 3, 6 and afterwards in case of dysphagia recurrence. Pre and post-stenting dysphagia status as well as complications were prospectively collected. Results: Stents were successfully placed in all patients. No early complications occurred. Pre-stenting mean dysphagia score was 2.8þ0.68. At 3 months, stents were endoscopically in place, but partially fragmented in 3/6 patients. Stent migration was observed in 2 patients (17%). One of these patients was treated again by a second biodegradable stent and is still under follow-up and free of dysphagia. The other patient did not require further treatment because of resolution of the stricture and absence of symptoms at the time of migration. Minor bleeding without a significant drop in Hb lwas observed in 1 patient. After a median follow-up of 22 weeks (4-32), mean dysphagia score was 0.25þ0.12 with 10/12 patients free of dysphagia and 2 patients with persistent but mild dysphagia (grade 1in one patients and grade 2 in a second patient). Conclusions: In this preliminary evaluation, the biodegradable stent afforded a significant relief of dysphagia in a small group of patients with refractory benign esophageal strictures. A larger study with longer follow-up is required to validate these results.
738 Complications of Long-Term Esophageal Stenting in the Management of Benign Perforations Nicoline C. Van Heel, Jelle Haringsma, Manon Spaander, Ernst J. Kuipers Background: The standard approach to benign esophageal perforations includes conservative treatment, surgical repair or esophagectomy. Removable selfexpandable metal stents (SEMS) are increasingly used for relief of perforations of the esophagus. In the current cohort study we investigated the clinical value of SEMS placement for non-malignant esophageal defects. Methods: In a prospective single center observational study, 32 consecutive patients were included. Data were collected from a prospective database, operation reports and endoscopy records. To obtain missing information, we contacted the patients, their relatives or their general practitioner. Results: Thirty-two patients (66% male; median age 73 years (range: 13-87 years)) were followed after initial placement of SEMS (median followup 2 years (range 1 day-7 years)). The majority of perforations were iatrogenic (nZ19), other causes included Boerhaave’s syndrome (nZ9), trauma (nZ1), foreign body (nZ1) and anastomotic leakage (nZ2). Three patients received a fully-covered SEMS and 29 patients received a partially-covered SEMS. Placement was technically successful in all patients. Three patients with Boerhaave’s syndrome required an esophagectomy because of immediate stent failure. The overall 90 day mortality rate was 19%. Stent migration occurred in 10 patients after a median of 12 days, requiring stent reposition (nZ4), additional stent insertion (nZ3) stent removal (nZ1), or no intervention (nZ2). Twelve patients required 16 additional stents for either persistent leakage during stent therapy (nZ8) or after SEMS extraction (nZ8). Four patients underwent debridement of an empyema. A total of 31 endoscopic stent extractions were performed. Of these, 21 stent extractions
Volume 69, No. 5 : 2009 GASTROINTESTINAL ENDOSCOPY AB123