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Predictors of Enteryx® Outcomes at 12 Months
*W1509 Endoscopic Full-Thickness Plication for GERD: Durability at 12-Months Douglas Pleskow, Richard Rothstein, Simon Lo, Robert Hawes, Richard Kozarek, Gregory Haber, Christopher Gostout, Anthony Lembo Background: The Plicator procedure has been designed to inhibit gastroesophageal (GE) reflux by fixating the full-thickness of the cardia wall under direct endoscopic visualization. The resulting serosa-to-serosa tissue union may help to accentuate and restore the valvular mechanism of the GE junction. Aim: To assess safety, efficacy, and 12-month durability of endoscopic full-thickness plication in patients with symptomatic GERD. Methods: Patients with chronic heartburn requiring maintenance anti-secretory therapy were recruited. Exclusions were hiatal hernia (>2cm), Grades III and IV esophagitis, and Barrett’s. The following were assessed at baseline (on and off-meds) and 12 month post-plication: GERDHRQL, GSRS, SF-36 questionnaires, and medication use. Additionally, 24-hr pH-metry and manometry were measured at baseline, three-months (pH/ manometry) and six-months (pH only) post-plication. All patients received a single, full-thickness plication in the gastric cardia 1-2cm below the GE junction. Results: Sixty-four patients (mean age 46.3, range 23-71) underwent endoscopic full-thickness plication. No re-treatments were performed. 12 months postprocedure, proton pump inhibitor (PPI) therapy remained completely discontinued in 68% (36/53) of PPI dependent patients and median GERD-HRQL scores (n=57) were improved when compared to baseline off-med (19.0 vs. 5.0) and on-med (13.0 vs. 5.0). In 24-hour pH-metry performed at six-months postprocedure (n = 46), 80% of patients demonstrated an improvement in distal esophageal acid exposure. Median % time pH < 4 decreased 39% with 30% of patients experiencing a normalization of pH at 6-months. No significant change in esophageal manometry was noted. All procedure related adverse events occurred acutely, including one gastric perforation which was managed conservatively without sequelae. Common adverse events included sore throat (41%) and abdominal pain (20%), resolving spontaneously within several days postprocedure. Conclusions: In this study, a single full-thickness plication placed at the GE junction reduced symptoms, medication use and esophageal acid exposure associated with GERD. Sustained reduction in PPI use at 1-year follow-up suggests durability of full-thickness tissue apposition.
*W1510 Lugol's Chromoendoscopy Improves the Detection of Esophagitis in Patients with Nonerosive Reflux Disease Frederick T. Dy, Jose D. Sollano Jr., Alvin P. Quino, Johnny T. Go, Melchor M. Chan, Victoriano Y. Lim, Carmelita D. Dalupang BACKGROUND Erosive esophagitis in patients with reflux symptoms is highly specific for the diagnosis of gastroesophageal reflux disease (GERD). However, in 35-70%, the endoscopic examination may be normal. Histologic examination of random biopsies taken during endoscopy may increase its diagnostic yield. Lugol’s chromoendoscopy enhances detection of squamous cells with diminished or absent glycogen content, an observation noted in cancer and in esophagitis. Thus, the objective of this study is to determine whether Lugol’s-directed biopsy (LDB) at the distal esophagus increases the diagnostic yield of endoscopy in nonerosive reflux disease (NERD). METHODS Patients with reflux symptoms occurring at least 3 episodes per week for a minimum of three months and demonstrated no esophageal mucosal injury on endoscopy were enrolled. Excluded were those patients with allergy to iodine, thyroid disease, and intake of H2 receptor antagonist or proton pump inhibitor within the past 28 days. A first set of biopsy was taken randomly from one half of the lumen starting 2 cm from the Z-line. Thereafter, 10-20 ml of Lugol’s solution (12 g iodine and 24 g potassium iodide in distilled water) was sprayed into the distal third. To ensure maximal staining of the mucosa, a distilled water rinse was done one minute after dye instillation. A second set of biopsy was taken from the opposite half of the lumen specifically targeting unstained areas. Specimens were interpreted by a single, blinded pathologist. Histologic esophagitis (HE) was established based on the Frierson’s criteria. RESULTS Of 117 GERD patients screened, endoscopy was normal in 64 (54.7%) subjects. Male to female ratio was 1:1.4 with a mean age of 41.6 +/- 13.7 years. After Lugol’s spray, 60 (93.7%) patients exhibited unstained areas from which targeted biopsies were performed. Histologic esophagitis was seen in 44 random biopsies, while HE was noted in 55 Lugol’s-directed biopsies (73.3% vs 91.7%, p=0.009). CONCLUSIONS Lugol’s chromoendoscopy improves the detection of esophagitis and increases the diagnostic yield of endoscopy in nonerosive reflux disease.
VOLUME 59, NO. 5, 2004
*W1511 Spongiosis as a Marker for Gastroesophageal Reflux Disease (GERD) in Esophageal Biopsies Pablo A. Bejarano, Steven A. Simon, Mehdi Nassiri, Miami Endoscopy Center Background:The histological diagnosis of GERD is not based on a single feature in esophageal biopsies. However, the presence of eosinophils is considered a sensitive marker for GERD. A morphological finding that can also be seen in GERD is spongiosis, which is the presence of edema between squamous cells. However, the relationship between spongiosis, eosinophils and other histological features attributed to GERD has not been analyzed in detail. Methods: Histological sections of 57 well-oriented esophageal biopsies were examined microscopically for the presence of eosinophils. The latter were quantified per 10 high power fields (hpf). Spongiosis was graded as absent, mild, moderate and severe (0-3). Parallel sections were stained for PAS and evaluated for the thickness of the basal cell layer component and measured by using an ocular micrometer. The number of layers of basal cells were also counted. Other findings that were quantified included intraepithelial lymphocytes, congestion of the tips of the papillae, neutrophilic infiltrates, hyperkeratosis, hypergranulosis and ulceration. For statistical analysis, the Spearman rank order test was used. Results: 35 biopsies lacked eosinophils and 22 had eosinophils that ranged from 1 to 60 per 10 hpf. Spongiosis was seen in 96% of the cases with eosinophils and in only 74% of the cases without eosinophils. There was a positive correlation (p=0.003) between the presence of eosinophils and spongiosis with 0.09, 0.95, 2.14 and 14 eosinophils per 10 hpf in grades 1, 2, and 3 of spongiosis, respectively. The average thickness of the basal cell layer for the cases with esinophils was 0.26 mm; whereas, for those without eosinophils it was 0.19 mm (p=0.03). Basal cells occupied 27.7% of the full thickness of the squamous mucosa in cases infiltrated by eosinophils and 23% in the cases without eosinophils. There was no correlation with intraepithelial lymphocytes, neutrophilic infiltrates, congestion, ulceration, hyperkaratosis or hypergranulosis. Conclusion:The presence of spongiosis in esophageal biopsies is associated with eosinophilic infiltrates and thus may help in the histologic diagnosis of GERD. Additional studies are needed to correlate with the clinical impression of GERD.
*W1512 Predictors of EnteryxÒ Outcomes at 12 Months Jacques Deviere, Lawrence B. Cohen, James Aisenberg, Robert A. Ganz, Glen A. Lehman, T. Raymond Foley, David A. Johnson, Gregory B. Haber, Jeffrey H. Peters Purpose: To evaluate predictors of successful outcome for EnteryxÒ, an injectable copolymer designed to treat the symptoms of GERD. Methods: 118 patients with well documented GERD completed 12 month follow-up in a US IDE study. Study outcomes at 12 months and their relationships to baseline and procedural variables were explored using logistic regression models. Baseline variables were gender, age, body mass index (BMI), hiatal hernia presence (0 to 3 cm), esophagitis (Savary-Miller grade), and procedural variables (eg, injection total number and volume). All patients were responsive to proton pump inhibitor (PPI) therapy and sustained early relapse of symptoms upon withdrawal. Baseline endoscopy was performed while the patient returned to PPIs with normalization of GERDHRQL scores. Results: The table lists p-values from logistic regression analyses of study outcomes versus baseline parameters. Baseline esophagitis (on PPIs) was a significant negative predictor of both PPI use improvement and GERD-HRQL score. Specifically, patients with Grade 2 esophagitis at baseline were less likely to have elimination or $50% reduction in PPI use (7/13) as compared to patients with Grade 0 (68/79) or 1 (22/23) esophagitis. There was no statistically significant difference in PPI or pH outcome by gender, but GERD-HRQL symptom scores were significantly more likely to improve (p=0.01) in males (86%; 57/66) than in females (67%; 32/48). Conclusions: EnteryxÒ is more likely to result in a successful outcome in patients who have lower grade esophagitis (on PPIs). This does not mean that Enteryx is more successful only in mild GERD. As all patients entered into the study on PPI therapy, persistence of any esophagitis implies higher acid contact time, hence more severe GERD. No other parameters were shown to be significant predictors of outcome.
GASTROINTESTINAL ENDOSCOPY
P243
*W1510 Lugol's Chromoendoscopy Improves the Detection of Esophagitis in Patients with Nonerosive Reflux Disease Frederick T. Dy, Jose D. Sollano Jr., Alvin P. Quino, Johnny T. Go, Melchor M. Chan, Victoriano Y. Lim, Carmelita D. Dalupang BACKGROUND Erosive esophagitis in patients with reflux symptoms is highly specific for the diagnosis of gastroesophageal reflux disease (GERD). However, in 35-70%, the endoscopic examination may be normal. Histologic examination of random biopsies taken during endoscopy may increase its diagnostic yield. Lugol’s chromoendoscopy enhances detection of squamous cells with diminished or absent glycogen content, an observation noted in cancer and in esophagitis. Thus, the objective of this study is to determine whether Lugol’s-directed biopsy (LDB) at the distal esophagus increases the diagnostic yield of endoscopy in nonerosive reflux disease (NERD). METHODS Patients with reflux symptoms occurring at least 3 episodes per week for a minimum of three months and demonstrated no esophageal mucosal injury on endoscopy were enrolled. Excluded were those patients with allergy to iodine, thyroid disease, and intake of H2 receptor antagonist or proton pump inhibitor within the past 28 days. A first set of biopsy was taken randomly from one half of the lumen starting 2 cm from the Z-line. Thereafter, 10-20 ml of Lugol’s solution (12 g iodine and 24 g potassium iodide in distilled water) was sprayed into the distal third. To ensure maximal staining of the mucosa, a distilled water rinse was done one minute after dye instillation. A second set of biopsy was taken from the opposite half of the lumen specifically targeting unstained areas. Specimens were interpreted by a single, blinded pathologist. Histologic esophagitis (HE) was established based on the Frierson’s criteria. RESULTS Of 117 GERD patients screened, endoscopy was normal in 64 (54.7%) subjects. Male to female ratio was 1:1.4 with a mean age of 41.6 +/- 13.7 years. After Lugol’s spray, 60 (93.7%) patients exhibited unstained areas from which targeted biopsies were performed. Histologic esophagitis was seen in 44 random biopsies, while HE was noted in 55 Lugol’s-directed biopsies (73.3% vs 91.7%, p=0.009). CONCLUSIONS Lugol’s chromoendoscopy improves the detection of esophagitis and increases the diagnostic yield of endoscopy in nonerosive reflux disease.
VOLUME 59, NO. 5, 2004
*W1511 Spongiosis as a Marker for Gastroesophageal Reflux Disease (GERD) in Esophageal Biopsies Pablo A. Bejarano, Steven A. Simon, Mehdi Nassiri, Miami Endoscopy Center Background:The histological diagnosis of GERD is not based on a single feature in esophageal biopsies. However, the presence of eosinophils is considered a sensitive marker for GERD. A morphological finding that can also be seen in GERD is spongiosis, which is the presence of edema between squamous cells. However, the relationship between spongiosis, eosinophils and other histological features attributed to GERD has not been analyzed in detail. Methods: Histological sections of 57 well-oriented esophageal biopsies were examined microscopically for the presence of eosinophils. The latter were quantified per 10 high power fields (hpf). Spongiosis was graded as absent, mild, moderate and severe (0-3). Parallel sections were stained for PAS and evaluated for the thickness of the basal cell layer component and measured by using an ocular micrometer. The number of layers of basal cells were also counted. Other findings that were quantified included intraepithelial lymphocytes, congestion of the tips of the papillae, neutrophilic infiltrates, hyperkeratosis, hypergranulosis and ulceration. For statistical analysis, the Spearman rank order test was used. Results: 35 biopsies lacked eosinophils and 22 had eosinophils that ranged from 1 to 60 per 10 hpf. Spongiosis was seen in 96% of the cases with eosinophils and in only 74% of the cases without eosinophils. There was a positive correlation (p=0.003) between the presence of eosinophils and spongiosis with 0.09, 0.95, 2.14 and 14 eosinophils per 10 hpf in grades 1, 2, and 3 of spongiosis, respectively. The average thickness of the basal cell layer for the cases with esinophils was 0.26 mm; whereas, for those without eosinophils it was 0.19 mm (p=0.03). Basal cells occupied 27.7% of the full thickness of the squamous mucosa in cases infiltrated by eosinophils and 23% in the cases without eosinophils. There was no correlation with intraepithelial lymphocytes, neutrophilic infiltrates, congestion, ulceration, hyperkaratosis or hypergranulosis. Conclusion:The presence of spongiosis in esophageal biopsies is associated with eosinophilic infiltrates and thus may help in the histologic diagnosis of GERD. Additional studies are needed to correlate with the clinical impression of GERD.
*W1512 Predictors of EnteryxÒ Outcomes at 12 Months Jacques Deviere, Lawrence B. Cohen, James Aisenberg, Robert A. Ganz, Glen A. Lehman, T. Raymond Foley, David A. Johnson, Gregory B. Haber, Jeffrey H. Peters Purpose: To evaluate predictors of successful outcome for EnteryxÒ, an injectable copolymer designed to treat the symptoms of GERD. Methods: 118 patients with well documented GERD completed 12 month follow-up in a US IDE study. Study outcomes at 12 months and their relationships to baseline and procedural variables were explored using logistic regression models. Baseline variables were gender, age, body mass index (BMI), hiatal hernia presence (0 to 3 cm), esophagitis (Savary-Miller grade), and procedural variables (eg, injection total number and volume). All patients were responsive to proton pump inhibitor (PPI) therapy and sustained early relapse of symptoms upon withdrawal. Baseline endoscopy was performed while the patient returned to PPIs with normalization of GERDHRQL scores. Results: The table lists p-values from logistic regression analyses of study outcomes versus baseline parameters. Baseline esophagitis (on PPIs) was a significant negative predictor of both PPI use improvement and GERD-HRQL score. Specifically, patients with Grade 2 esophagitis at baseline were less likely to have elimination or $50% reduction in PPI use (7/13) as compared to patients with Grade 0 (68/79) or 1 (22/23) esophagitis. There was no statistically significant difference in PPI or pH outcome by gender, but GERD-HRQL symptom scores were significantly more likely to improve (p=0.01) in males (86%; 57/66) than in females (67%; 32/48). Conclusions: EnteryxÒ is more likely to result in a successful outcome in patients who have lower grade esophagitis (on PPIs). This does not mean that Enteryx is more successful only in mild GERD. As all patients entered into the study on PPI therapy, persistence of any esophagitis implies higher acid contact time, hence more severe GERD. No other parameters were shown to be significant predictors of outcome.
GASTROINTESTINAL ENDOSCOPY
P243