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Community practice evaluation of the effectiveness on the STRETTA procedure for the treatment of GERD
AJG – September, Suppl., 2001
62 The response of eosinophilic esophagitis to an elemental diet in children and adolescents Chris A Liacouras MD1, John E Markowitz MD1 and Eduardo Ruchelli MD1*. 1Division of Gastroenterology and Nutrition, The Children’s Hospital of Philadelphia, Philadelphia, PA, United States. Purpose: Since 1995, eosinophilic esophagitis (EE) has been a recognized entity in children. The diagnosis of EE is made in patients who have symptoms similar to those seen in patients with GERD but who are unresponsive to acid blockade therapy. Esophageal histology reveals greater than 20 eosinophils per high powered field (HPF). In the past, therapy for EE has consisted of stricture dilatation, corticosteroids, acid blockade and diet modification. AIM: To evaluate the effect of an elemental diet in children with EE. Methods: Prospective study, evaluating 57 children with GERD symptoms, unresponsive to proton pump inhibitors, who had esophageal biopsies demonstrating ⬎20 eosinophils per HPF (normal gastric and duodenal biopsies). All children underwent pH probe evaluation (off acid blockade). Three children with severe acid reflux by pH probe were referred for surgical therapy. 51 children with normal or borderline-normal pH probe results were prescribed an elemental diet consisting solely of Neocate 1⫹ and clear liquids consisting of water and 1 fruit (fruit juice). All patients receiving dietary therapy underwent repeat endoscopy after 1 month. Three children with EE refused dietary therapy. Results: 51 children were diagnosed with EE (33 males); average age 8.3 ⫾ 3.1 years; 36 (71%) displayed vomiting or regurgitation; 40 (78%) had abdominal pain; 26 (51%) had a history of asthma, rhinitis or eczema; 20 (39%) had a family history of allergic symptoms. Before diet, the number of distal esophageal eos (DEE) was 33.7 ⫾ 10.3; the number of mid esophageal eos (MEE) was 19.8 ⫾ 5.8; the number of reflux episodes/hr 3.0 ⫾ 1.8; number of reflux episodes ⬎5 minutes/hr 0.06 ⫾ 0.06; longest reflux episode (min) 6.8 ⫾ 2.2; reflux index (%) 5.0 ⫾ 1.6. After diet, 49 of 51 patients became asymptomatic with the number of DEE 1.0 ⫾ 0.9 (p ⬍ 0.005); 2/51 (4%) continued to have symptoms and had no significant change in DEE. There was no significant difference in the number of esophageal eos, response to diet, or presence of symptoms when compared to age or sex. Conclusions: EE should be considered in children with GERD symptoms and ⬎20 esophageal eos per HPF, depite the use of proton pump inhibitors. These patients respond symptomatically and histologically to an elemental formula and the elimination of complex dietary antigens.
63 The association between cholecystectomy and gastroesophageal reflux symptoms: a controlled prospective study Otto S Lin1, Lauren B Gerson2 and George Triadafilopoulos2*, 1 Gastroenterology Division, Virginia Mason Medical Center, Seattle, Washington, United States; and 2Gastroenterology Division, Stanford University Medical Center, Stanford, California, United States. Purpose: It has been noted that open and laparoscopic cholecystectomy appears to cause or worsen gastroesophageal reflux symptoms, although the mechanism is unclear Two prospective observational studies, two crosssectional studies and one retrospective cohort study have reported that reflux symptoms and intraesophageal acid reflux worsen after cholecystectomy. However, the retrospective studies did not adjust for confounding, while both prospective studies were uncontrolled. Furthermore, the follow-up periods were short and the sample sizes relatively small. Methods: We performed a prospective, controlled study to assess changes in reflux symptoms after elective cholecystectomy for cholelithiasis (study group) or inguinal hernia repair (controls). Subjects filled out two previ-
Abstracts
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ously validated questionnaires 1–15 days prior to their surgery and 2– 8 weeks afterwards. Differences in the Reflux Symptom Score (RSS), scored from 0 to 6.5, and the Health Related Quality of Life Reflux Questionnaire (HRQOL), scored from 0 to 50, were compared between the two groups using the 2-tailed unpaired Student t-test. Results: 35 consecutive cholecystectomy and 48 inguinal hernia repair subjects were enrolled. The two groups were similar in age, comorbid health conditions, medication use, and smoking/alcohol habits; however, the cholecystectomy group consisted of 42% women versus 12% for the hernia group. 54% of the cholecystectomy subjects and 19% of the hernia subjects decreased their RSS after the surgery, while 35% of the cholecystectomy subjects and 33% of the hernia subjects decreased their HRQOL. The RSS decreased by a mean of 1.04 after the surgery in the cholecystectomy group and increased by 0.03 in the hernia group (p ⫽ 0.006). The HRQOL decreased by a mean of 4.62 after the surgery in the cholecystectomy group and decreased by 0.52 in the hernia group (p ⫽ 0.01). Conclusions: As the only prospective controlled study to date on this topic, this study finds a statistically significant decrease in reflux symptoms after surgery in the cholecystectomy group as compared to the control group. These results contradict those of previous studies and suggest that cholecystectomy may not be a risk factor for the development of reflux.
64 Community practice evaluation of the effectiveness on the STRETTA procedure for the treatment of GERD Donald E Mansell1* 1Gastroenterology, Feather River Hospital, Paradise, California, United States. Purpose: This is a single center, community practice evaluation of the effectiveness of endoluminal radiofrequency (RF) energy delivery, the STRETTA procedure, for the treatment of gastroesophageal reflux disease (GERD) regarding GERD symptoms, quality of life (QOL), and medication use. Methods: Data was collected on 29 patients with a diagnosis of chronic GERD, daily symptoms of heartburn and/or regurgitation, daily anti-secretory medication use, and pathologic esophageal acid exposure by 24-hr pH study or endoscopic biopsy. Pretreatment esophageal motility was performed to exclude patients with achalasia. After conscious sedation and standard endoscopy, we delivered RF energy with the STRETTA catheter and thermocouple-controlled generator to create thermal lesions in the muscle of the gastroesophageal junction. Mucosal integrity was preserved via cooling with constant irrigation through the device. GERD symptom scores (0 –50), heartburn (0 –5), quality of life (SF-36), and medication use were assessed at baseline and post-treatment. Results were stratified according to presence or absence of hiatal hernia. Results: Twenty-two women and 7 men were treated (age 63.1 ⫾ 14 years, mean ⫾ SD). At follow-up (136 ⫾ 78 days), there were significant improvements in the median heartburn score (4 to 1, p ⬍ 0.001), GERD score (32 to 9 p ⬍ 0.001), satisfaction (1 to 5, p ⬍ 0.001), mental SF-36 (52.5 to 59.4, p ⫽ 0.001), physical SF-36 (31.3 to 39.2, p ⬍ 0.001). Subgroup analysis demonstrated that presence of a hiatal hernia had no impact on the observed improvements in GERD, heartburn, QOL, or medication use (p ⬎0.05). Medication use improved from baseline (79% 2 ⫻ PPI, 17% 1 ⫻ PPI, and 4% H2RA) to post-treatment (17% 2 ⫻ PPI, 7% 1 ⫻ PPI, 7% H2RA, and 69% no drug or prn medication only). There were no adverse effects requiring therapeutic or diagnostic intervention. One patient had fundoplication for incomplete symptom control. Conclusions: The STRETTA procedure significantly improves GERD symptoms, patient quality of life, and medication use in this predominantly elderly, female study population both with and without hiatal hernia.
62 The response of eosinophilic esophagitis to an elemental diet in children and adolescents Chris A Liacouras MD1, John E Markowitz MD1 and Eduardo Ruchelli MD1*. 1Division of Gastroenterology and Nutrition, The Children’s Hospital of Philadelphia, Philadelphia, PA, United States. Purpose: Since 1995, eosinophilic esophagitis (EE) has been a recognized entity in children. The diagnosis of EE is made in patients who have symptoms similar to those seen in patients with GERD but who are unresponsive to acid blockade therapy. Esophageal histology reveals greater than 20 eosinophils per high powered field (HPF). In the past, therapy for EE has consisted of stricture dilatation, corticosteroids, acid blockade and diet modification. AIM: To evaluate the effect of an elemental diet in children with EE. Methods: Prospective study, evaluating 57 children with GERD symptoms, unresponsive to proton pump inhibitors, who had esophageal biopsies demonstrating ⬎20 eosinophils per HPF (normal gastric and duodenal biopsies). All children underwent pH probe evaluation (off acid blockade). Three children with severe acid reflux by pH probe were referred for surgical therapy. 51 children with normal or borderline-normal pH probe results were prescribed an elemental diet consisting solely of Neocate 1⫹ and clear liquids consisting of water and 1 fruit (fruit juice). All patients receiving dietary therapy underwent repeat endoscopy after 1 month. Three children with EE refused dietary therapy. Results: 51 children were diagnosed with EE (33 males); average age 8.3 ⫾ 3.1 years; 36 (71%) displayed vomiting or regurgitation; 40 (78%) had abdominal pain; 26 (51%) had a history of asthma, rhinitis or eczema; 20 (39%) had a family history of allergic symptoms. Before diet, the number of distal esophageal eos (DEE) was 33.7 ⫾ 10.3; the number of mid esophageal eos (MEE) was 19.8 ⫾ 5.8; the number of reflux episodes/hr 3.0 ⫾ 1.8; number of reflux episodes ⬎5 minutes/hr 0.06 ⫾ 0.06; longest reflux episode (min) 6.8 ⫾ 2.2; reflux index (%) 5.0 ⫾ 1.6. After diet, 49 of 51 patients became asymptomatic with the number of DEE 1.0 ⫾ 0.9 (p ⬍ 0.005); 2/51 (4%) continued to have symptoms and had no significant change in DEE. There was no significant difference in the number of esophageal eos, response to diet, or presence of symptoms when compared to age or sex. Conclusions: EE should be considered in children with GERD symptoms and ⬎20 esophageal eos per HPF, depite the use of proton pump inhibitors. These patients respond symptomatically and histologically to an elemental formula and the elimination of complex dietary antigens.
63 The association between cholecystectomy and gastroesophageal reflux symptoms: a controlled prospective study Otto S Lin1, Lauren B Gerson2 and George Triadafilopoulos2*, 1 Gastroenterology Division, Virginia Mason Medical Center, Seattle, Washington, United States; and 2Gastroenterology Division, Stanford University Medical Center, Stanford, California, United States. Purpose: It has been noted that open and laparoscopic cholecystectomy appears to cause or worsen gastroesophageal reflux symptoms, although the mechanism is unclear Two prospective observational studies, two crosssectional studies and one retrospective cohort study have reported that reflux symptoms and intraesophageal acid reflux worsen after cholecystectomy. However, the retrospective studies did not adjust for confounding, while both prospective studies were uncontrolled. Furthermore, the follow-up periods were short and the sample sizes relatively small. Methods: We performed a prospective, controlled study to assess changes in reflux symptoms after elective cholecystectomy for cholelithiasis (study group) or inguinal hernia repair (controls). Subjects filled out two previ-
Abstracts
S21
ously validated questionnaires 1–15 days prior to their surgery and 2– 8 weeks afterwards. Differences in the Reflux Symptom Score (RSS), scored from 0 to 6.5, and the Health Related Quality of Life Reflux Questionnaire (HRQOL), scored from 0 to 50, were compared between the two groups using the 2-tailed unpaired Student t-test. Results: 35 consecutive cholecystectomy and 48 inguinal hernia repair subjects were enrolled. The two groups were similar in age, comorbid health conditions, medication use, and smoking/alcohol habits; however, the cholecystectomy group consisted of 42% women versus 12% for the hernia group. 54% of the cholecystectomy subjects and 19% of the hernia subjects decreased their RSS after the surgery, while 35% of the cholecystectomy subjects and 33% of the hernia subjects decreased their HRQOL. The RSS decreased by a mean of 1.04 after the surgery in the cholecystectomy group and increased by 0.03 in the hernia group (p ⫽ 0.006). The HRQOL decreased by a mean of 4.62 after the surgery in the cholecystectomy group and decreased by 0.52 in the hernia group (p ⫽ 0.01). Conclusions: As the only prospective controlled study to date on this topic, this study finds a statistically significant decrease in reflux symptoms after surgery in the cholecystectomy group as compared to the control group. These results contradict those of previous studies and suggest that cholecystectomy may not be a risk factor for the development of reflux.
64 Community practice evaluation of the effectiveness on the STRETTA procedure for the treatment of GERD Donald E Mansell1* 1Gastroenterology, Feather River Hospital, Paradise, California, United States. Purpose: This is a single center, community practice evaluation of the effectiveness of endoluminal radiofrequency (RF) energy delivery, the STRETTA procedure, for the treatment of gastroesophageal reflux disease (GERD) regarding GERD symptoms, quality of life (QOL), and medication use. Methods: Data was collected on 29 patients with a diagnosis of chronic GERD, daily symptoms of heartburn and/or regurgitation, daily anti-secretory medication use, and pathologic esophageal acid exposure by 24-hr pH study or endoscopic biopsy. Pretreatment esophageal motility was performed to exclude patients with achalasia. After conscious sedation and standard endoscopy, we delivered RF energy with the STRETTA catheter and thermocouple-controlled generator to create thermal lesions in the muscle of the gastroesophageal junction. Mucosal integrity was preserved via cooling with constant irrigation through the device. GERD symptom scores (0 –50), heartburn (0 –5), quality of life (SF-36), and medication use were assessed at baseline and post-treatment. Results were stratified according to presence or absence of hiatal hernia. Results: Twenty-two women and 7 men were treated (age 63.1 ⫾ 14 years, mean ⫾ SD). At follow-up (136 ⫾ 78 days), there were significant improvements in the median heartburn score (4 to 1, p ⬍ 0.001), GERD score (32 to 9 p ⬍ 0.001), satisfaction (1 to 5, p ⬍ 0.001), mental SF-36 (52.5 to 59.4, p ⫽ 0.001), physical SF-36 (31.3 to 39.2, p ⬍ 0.001). Subgroup analysis demonstrated that presence of a hiatal hernia had no impact on the observed improvements in GERD, heartburn, QOL, or medication use (p ⬎0.05). Medication use improved from baseline (79% 2 ⫻ PPI, 17% 1 ⫻ PPI, and 4% H2RA) to post-treatment (17% 2 ⫻ PPI, 7% 1 ⫻ PPI, 7% H2RA, and 69% no drug or prn medication only). There were no adverse effects requiring therapeutic or diagnostic intervention. One patient had fundoplication for incomplete symptom control. Conclusions: The STRETTA procedure significantly improves GERD symptoms, patient quality of life, and medication use in this predominantly elderly, female study population both with and without hiatal hernia.