The Stretta procedure for the treatment of GERD: 6 and 12 month follow-up of the U.S. open label trial

George Triadafilopoulos, John K. DiBaise, Timothy T. Nostrant, Neil H. Stollman, Paul K. Anderson, M. Michael Wolfe, Richard I. Rothstein, John Wo, Douglas A. Corley, Marco G. Patti, Louis V. Antignano, John S. Goff, Steven A. Edmundowicz, Donald O. Castell, John C. Rabine, Michael S. Kim, David S. Utley

Research output: Contribution to journalArticle

250 Citations (Scopus)

Abstract

Background: This multicenter prospective study investigated the longer-term (12 month) safety and efficacy of radiofrequency energy delivery for the treatment of GERD. Methods: A prospective study was conducted of 118 patients with chronic heartburn and/or regurgitation who required antisecretory medication daily and had demonstrated pathologic esophageal acid exposure, a sliding hiatal hernia (≤2 cm), and esophagitis (≤ grade 2). RF energy was delivered with the Stretta catheter and thermocouple-controlled generator to create thermal lesions below the mucosa at the gastroesophageal junction. GERD symptom scores, quality of life (SF-36), and medication use were assessed at 0, 1, 4, 6, and 12 months; esophageal acid exposure, motility, and endoscopy were assessed at 0 and 6 months. Results: Seventy-two men and 46 women were treated. At 12 months, 94 patients were available for follow-up. There were improvements after 12 months in the median heartburn score (4 to 1, p = 0.0001), GERD score (27 to 9, p = 0.0001), satisfaction (1 to 4, p = 0.0001), mental SF-36 (46.3 to 55.4, p <0.0001), and physical SF-36 (40.9 to 53.1, p = 0.0001); proton pump inhibitor requirement fell from 88.1% to 30% of patients. Esophageal acid exposure improved significantly (10.2% to 6.4%, p = 0.0001). There were 10 (8.6%) complications, none of which required therapeutic intervention. Conclusion: The Stretta procedure significantly improves GERD symptoms, quality of life, and esophageal acid exposure and eliminates the need for antisecretory medication in the majority of patients at 12 months.

Original languageEnglish (US)
Pages (from-to)149-156
Number of pages8
JournalGastrointestinal Endoscopy
Volume55
Issue number2
DOIs
StatePublished - Feb 2002
Externally publishedYes

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Gastroesophageal Reflux
Heartburn
Acids
Quality of Life
Prospective Studies
Esophagogastric Junction
Hiatal Hernia
Esophagitis
Proton Pump Inhibitors
Therapeutics
Endoscopy
Multicenter Studies
Mucous Membrane
Catheters
Hot Temperature
Safety

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Triadafilopoulos, G., DiBaise, J. K., Nostrant, T. T., Stollman, N. H., Anderson, P. K., Wolfe, M. M., ... Utley, D. S. (2002). The Stretta procedure for the treatment of GERD: 6 and 12 month follow-up of the U.S. open label trial. Gastrointestinal Endoscopy, 55(2), 149-156. https://doi.org/10.1067/mge.2002.121227

The Stretta procedure for the treatment of GERD : 6 and 12 month follow-up of the U.S. open label trial. / Triadafilopoulos, George; DiBaise, John K.; Nostrant, Timothy T.; Stollman, Neil H.; Anderson, Paul K.; Wolfe, M. Michael; Rothstein, Richard I.; Wo, John; Corley, Douglas A.; Patti, Marco G.; Antignano, Louis V.; Goff, John S.; Edmundowicz, Steven A.; Castell, Donald O.; Rabine, John C.; Kim, Michael S.; Utley, David S.

In: Gastrointestinal Endoscopy, Vol. 55, No. 2, 02.2002, p. 149-156.

Research output: Contribution to journalArticle

Triadafilopoulos, G, DiBaise, JK, Nostrant, TT, Stollman, NH, Anderson, PK, Wolfe, MM, Rothstein, RI, Wo, J, Corley, DA, Patti, MG, Antignano, LV, Goff, JS, Edmundowicz, SA, Castell, DO, Rabine, JC, Kim, MS & Utley, DS 2002, 'The Stretta procedure for the treatment of GERD: 6 and 12 month follow-up of the U.S. open label trial', Gastrointestinal Endoscopy, vol. 55, no. 2, pp. 149-156. https://doi.org/10.1067/mge.2002.121227
Triadafilopoulos G, DiBaise JK, Nostrant TT, Stollman NH, Anderson PK, Wolfe MM et al. The Stretta procedure for the treatment of GERD: 6 and 12 month follow-up of the U.S. open label trial. Gastrointestinal Endoscopy. 2002 Feb;55(2):149-156. https://doi.org/10.1067/mge.2002.121227
Triadafilopoulos, George ; DiBaise, John K. ; Nostrant, Timothy T. ; Stollman, Neil H. ; Anderson, Paul K. ; Wolfe, M. Michael ; Rothstein, Richard I. ; Wo, John ; Corley, Douglas A. ; Patti, Marco G. ; Antignano, Louis V. ; Goff, John S. ; Edmundowicz, Steven A. ; Castell, Donald O. ; Rabine, John C. ; Kim, Michael S. ; Utley, David S. / The Stretta procedure for the treatment of GERD : 6 and 12 month follow-up of the U.S. open label trial. In: Gastrointestinal Endoscopy. 2002 ; Vol. 55, No. 2. pp. 149-156.
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abstract = "Background: This multicenter prospective study investigated the longer-term (12 month) safety and efficacy of radiofrequency energy delivery for the treatment of GERD. Methods: A prospective study was conducted of 118 patients with chronic heartburn and/or regurgitation who required antisecretory medication daily and had demonstrated pathologic esophageal acid exposure, a sliding hiatal hernia (≤2 cm), and esophagitis (≤ grade 2). RF energy was delivered with the Stretta catheter and thermocouple-controlled generator to create thermal lesions below the mucosa at the gastroesophageal junction. GERD symptom scores, quality of life (SF-36), and medication use were assessed at 0, 1, 4, 6, and 12 months; esophageal acid exposure, motility, and endoscopy were assessed at 0 and 6 months. Results: Seventy-two men and 46 women were treated. At 12 months, 94 patients were available for follow-up. There were improvements after 12 months in the median heartburn score (4 to 1, p = 0.0001), GERD score (27 to 9, p = 0.0001), satisfaction (1 to 4, p = 0.0001), mental SF-36 (46.3 to 55.4, p <0.0001), and physical SF-36 (40.9 to 53.1, p = 0.0001); proton pump inhibitor requirement fell from 88.1{\%} to 30{\%} of patients. Esophageal acid exposure improved significantly (10.2{\%} to 6.4{\%}, p = 0.0001). There were 10 (8.6{\%}) complications, none of which required therapeutic intervention. Conclusion: The Stretta procedure significantly improves GERD symptoms, quality of life, and esophageal acid exposure and eliminates the need for antisecretory medication in the majority of patients at 12 months.",
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T2 - 6 and 12 month follow-up of the U.S. open label trial

AU - Triadafilopoulos, George

AU - DiBaise, John K.

AU - Nostrant, Timothy T.

AU - Stollman, Neil H.

AU - Anderson, Paul K.

AU - Wolfe, M. Michael

AU - Rothstein, Richard I.

AU - Wo, John

AU - Corley, Douglas A.

AU - Patti, Marco G.

AU - Antignano, Louis V.

AU - Goff, John S.

AU - Edmundowicz, Steven A.

AU - Castell, Donald O.

AU - Rabine, John C.

AU - Kim, Michael S.

AU - Utley, David S.

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N2 - Background: This multicenter prospective study investigated the longer-term (12 month) safety and efficacy of radiofrequency energy delivery for the treatment of GERD. Methods: A prospective study was conducted of 118 patients with chronic heartburn and/or regurgitation who required antisecretory medication daily and had demonstrated pathologic esophageal acid exposure, a sliding hiatal hernia (≤2 cm), and esophagitis (≤ grade 2). RF energy was delivered with the Stretta catheter and thermocouple-controlled generator to create thermal lesions below the mucosa at the gastroesophageal junction. GERD symptom scores, quality of life (SF-36), and medication use were assessed at 0, 1, 4, 6, and 12 months; esophageal acid exposure, motility, and endoscopy were assessed at 0 and 6 months. Results: Seventy-two men and 46 women were treated. At 12 months, 94 patients were available for follow-up. There were improvements after 12 months in the median heartburn score (4 to 1, p = 0.0001), GERD score (27 to 9, p = 0.0001), satisfaction (1 to 4, p = 0.0001), mental SF-36 (46.3 to 55.4, p <0.0001), and physical SF-36 (40.9 to 53.1, p = 0.0001); proton pump inhibitor requirement fell from 88.1% to 30% of patients. Esophageal acid exposure improved significantly (10.2% to 6.4%, p = 0.0001). There were 10 (8.6%) complications, none of which required therapeutic intervention. Conclusion: The Stretta procedure significantly improves GERD symptoms, quality of life, and esophageal acid exposure and eliminates the need for antisecretory medication in the majority of patients at 12 months.

AB - Background: This multicenter prospective study investigated the longer-term (12 month) safety and efficacy of radiofrequency energy delivery for the treatment of GERD. Methods: A prospective study was conducted of 118 patients with chronic heartburn and/or regurgitation who required antisecretory medication daily and had demonstrated pathologic esophageal acid exposure, a sliding hiatal hernia (≤2 cm), and esophagitis (≤ grade 2). RF energy was delivered with the Stretta catheter and thermocouple-controlled generator to create thermal lesions below the mucosa at the gastroesophageal junction. GERD symptom scores, quality of life (SF-36), and medication use were assessed at 0, 1, 4, 6, and 12 months; esophageal acid exposure, motility, and endoscopy were assessed at 0 and 6 months. Results: Seventy-two men and 46 women were treated. At 12 months, 94 patients were available for follow-up. There were improvements after 12 months in the median heartburn score (4 to 1, p = 0.0001), GERD score (27 to 9, p = 0.0001), satisfaction (1 to 4, p = 0.0001), mental SF-36 (46.3 to 55.4, p <0.0001), and physical SF-36 (40.9 to 53.1, p = 0.0001); proton pump inhibitor requirement fell from 88.1% to 30% of patients. Esophageal acid exposure improved significantly (10.2% to 6.4%, p = 0.0001). There were 10 (8.6%) complications, none of which required therapeutic intervention. Conclusion: The Stretta procedure significantly improves GERD symptoms, quality of life, and esophageal acid exposure and eliminates the need for antisecretory medication in the majority of patients at 12 months.

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