Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial

John G. Hunter; Peter J. Kahrilas; Reginald C.W. Bell; Erik B. Wilson; Karim S. Trad; James P. Dolan; Kyle A. Perry; Brant K. Oelschlager; Nathaniel J. Soper; Brad E. Snyder; Miguel A. Burch; William Scott Melvin; Kevin M. Reavis; Daniel G. Turgeon; Eric S. Hungness; Brian S. Diggs

doi:10.1053/j.gastro.2014.10.009

Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial

John G. Hunter^*, Peter J. Kahrilas, Reginald C.W. Bell, Erik B. Wilson, Karim S. Trad, James P. Dolan, Kyle A. Perry, Brant K. Oelschlager, Nathaniel J. Soper, Brad E. Snyder, Miguel A. Burch, William Scott Melvin, Kevin M. Reavis, Daniel G. Turgeon, Eric S. Hungness, Brian S. Diggs

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

174 Scopus citations

Abstract

Background & Aims Transoral esophagogastric fundoplication (TF) can decrease or eliminate features of gastroesophageal reflux disease (GERD) in some patients whose symptoms persist despite proton pump inhibitor (PPI) therapy. We performed a prospective, sham-controlled trial to determine if TF reduced troublesome regurgitation to a greater extent than PPIs in patients with GERD. Methods We screened 696 patients with troublesome regurgitation despite daily PPI use with 3 validated GERD-specific symptom scales, on and off PPIs. Those with at least troublesome regurgitation (based on the Montreal definition) on PPIs underwent barium swallow, esophagogastroduodenoscopy, 48-hour esophageal pH monitoring (off PPIs), and high-resolution esophageal manometry analyses. Patients with GERD and hiatal hernias ≤2 cm were randomly assigned to groups that underwent TF and then received 6 months of placebo (n = 87), or sham surgery and 6 months of once- or twice-daily omeprazole (controls, n = 42). Patients were blinded to therapy during follow-up period and reassessed at 2, 12, and 26 weeks. At 6 months, patients underwent 48-hour esophageal pH monitoring and esophagogastroduodenoscopy. Results By intention-to-treat analysis, TF eliminated troublesome regurgitation in a larger proportion of patients (67%) than PPIs (45%) (P =.023). A larger proportion of controls had no response at 3 months (36%) than subjects that received TF (11%; P =.004). Control of esophageal pH improved after TF (mean 9.3% before and 6.3% after; P <.001), but not after sham surgery (mean 8.6% before and 8.9% after). Subjects from both groups who completed the protocol had similar reductions in GERD symptom scores. Severe complications were rare (3 subjects receiving TF and 1 receiving the sham surgery). Conclusions TF was an effective treatment for patients with GERD symptoms, particularly in those with persistent regurgitation despite PPI therapy, based on evaluation 6 months after the procedure. Clinicaltrials.gov no: NCT01136980.

Original language	English (US)
Pages (from-to)	324-333.e5
Journal	Gastroenterology
Volume	148
Issue number	2
DOIs	https://doi.org/10.1053/j.gastro.2014.10.009
State	Published - Feb 1 2015

Funding

Conflicts of interest These authors disclose the following: John Hunter is a consultant for EndoGastric Solutions. Peter Kahrilas is a consultant for AstraZeneca, Pfizer, and Trimedyne; has been a consultant for GlaxoSmithKline; and has been on advisory boards for Torax Medical and Reckitt Benckiser. Reginald Bell has received research grant from EndoGastric Solutions. Erik Wilson is a consultant for Apollo, Gore Medical, and Ethicon. Karim Trad has acted as a speaker bureau member and has received speaking honoraria from EndoGastric Solutions. Brant Oelschlager is a consultant and has received a research grant from EndoGastric Solutions. Kevin Reavis is a consultant for EndoGastric Solutions. Eric Hungness received an honorarium as part of being Northwestern University faculty for a surgical training course with Baxter. The remaining authors disclose no conflicts.

Keywords

Esophagus
EsophyX
Stomach
TIF

ASJC Scopus subject areas

Hepatology
Gastroenterology

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10.1053/j.gastro.2014.10.009

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Hunter, J. G., Kahrilas, P. J., Bell, R. C. W., Wilson, E. B., Trad, K. S., Dolan, J. P., Perry, K. A., Oelschlager, B. K., Soper, N. J., Snyder, B. E., Burch, M. A., Melvin, W. S., Reavis, K. M., Turgeon, D. G., Hungness, E. S., & Diggs, B. S. (2015). Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial. Gastroenterology, 148(2), 324-333.e5. https://doi.org/10.1053/j.gastro.2014.10.009

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title = "Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial",

abstract = "Background & Aims Transoral esophagogastric fundoplication (TF) can decrease or eliminate features of gastroesophageal reflux disease (GERD) in some patients whose symptoms persist despite proton pump inhibitor (PPI) therapy. We performed a prospective, sham-controlled trial to determine if TF reduced troublesome regurgitation to a greater extent than PPIs in patients with GERD. Methods We screened 696 patients with troublesome regurgitation despite daily PPI use with 3 validated GERD-specific symptom scales, on and off PPIs. Those with at least troublesome regurgitation (based on the Montreal definition) on PPIs underwent barium swallow, esophagogastroduodenoscopy, 48-hour esophageal pH monitoring (off PPIs), and high-resolution esophageal manometry analyses. Patients with GERD and hiatal hernias ≤2 cm were randomly assigned to groups that underwent TF and then received 6 months of placebo (n = 87), or sham surgery and 6 months of once- or twice-daily omeprazole (controls, n = 42). Patients were blinded to therapy during follow-up period and reassessed at 2, 12, and 26 weeks. At 6 months, patients underwent 48-hour esophageal pH monitoring and esophagogastroduodenoscopy. Results By intention-to-treat analysis, TF eliminated troublesome regurgitation in a larger proportion of patients (67%) than PPIs (45%) (P =.023). A larger proportion of controls had no response at 3 months (36%) than subjects that received TF (11%; P =.004). Control of esophageal pH improved after TF (mean 9.3% before and 6.3% after; P <.001), but not after sham surgery (mean 8.6% before and 8.9% after). Subjects from both groups who completed the protocol had similar reductions in GERD symptom scores. Severe complications were rare (3 subjects receiving TF and 1 receiving the sham surgery). Conclusions TF was an effective treatment for patients with GERD symptoms, particularly in those with persistent regurgitation despite PPI therapy, based on evaluation 6 months after the procedure. Clinicaltrials.gov no: NCT01136980.",

keywords = "Esophagus, EsophyX, Stomach, TIF",

author = "Hunter, {John G.} and Kahrilas, {Peter J.} and Bell, {Reginald C.W.} and Wilson, {Erik B.} and Trad, {Karim S.} and Dolan, {James P.} and Perry, {Kyle A.} and Oelschlager, {Brant K.} and Soper, {Nathaniel J.} and Snyder, {Brad E.} and Burch, {Miguel A.} and Melvin, {William Scott} and Reavis, {Kevin M.} and Turgeon, {Daniel G.} and Hungness, {Eric S.} and Diggs, {Brian S.}",

note = "Publisher Copyright: {\textcopyright} 2015 AGA Institute.",

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doi = "10.1053/j.gastro.2014.10.009",

language = "English (US)",

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Hunter, JG, Kahrilas, PJ, Bell, RCW, Wilson, EB, Trad, KS, Dolan, JP, Perry, KA, Oelschlager, BK, Soper, NJ, Snyder, BE, Burch, MA, Melvin, WS, Reavis, KM, Turgeon, DG, Hungness, ES & Diggs, BS 2015, 'Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial', Gastroenterology, vol. 148, no. 2, pp. 324-333.e5. https://doi.org/10.1053/j.gastro.2014.10.009

TY - JOUR

T1 - Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial

AU - Hunter, John G.

AU - Kahrilas, Peter J.

AU - Bell, Reginald C.W.

AU - Wilson, Erik B.

AU - Trad, Karim S.

AU - Dolan, James P.

AU - Perry, Kyle A.

AU - Oelschlager, Brant K.

AU - Soper, Nathaniel J.

AU - Snyder, Brad E.

AU - Burch, Miguel A.

AU - Melvin, William Scott

AU - Reavis, Kevin M.

AU - Turgeon, Daniel G.

AU - Hungness, Eric S.

AU - Diggs, Brian S.

PY - 2015/2/1

Y1 - 2015/2/1

N2 - Background & Aims Transoral esophagogastric fundoplication (TF) can decrease or eliminate features of gastroesophageal reflux disease (GERD) in some patients whose symptoms persist despite proton pump inhibitor (PPI) therapy. We performed a prospective, sham-controlled trial to determine if TF reduced troublesome regurgitation to a greater extent than PPIs in patients with GERD. Methods We screened 696 patients with troublesome regurgitation despite daily PPI use with 3 validated GERD-specific symptom scales, on and off PPIs. Those with at least troublesome regurgitation (based on the Montreal definition) on PPIs underwent barium swallow, esophagogastroduodenoscopy, 48-hour esophageal pH monitoring (off PPIs), and high-resolution esophageal manometry analyses. Patients with GERD and hiatal hernias ≤2 cm were randomly assigned to groups that underwent TF and then received 6 months of placebo (n = 87), or sham surgery and 6 months of once- or twice-daily omeprazole (controls, n = 42). Patients were blinded to therapy during follow-up period and reassessed at 2, 12, and 26 weeks. At 6 months, patients underwent 48-hour esophageal pH monitoring and esophagogastroduodenoscopy. Results By intention-to-treat analysis, TF eliminated troublesome regurgitation in a larger proportion of patients (67%) than PPIs (45%) (P =.023). A larger proportion of controls had no response at 3 months (36%) than subjects that received TF (11%; P =.004). Control of esophageal pH improved after TF (mean 9.3% before and 6.3% after; P <.001), but not after sham surgery (mean 8.6% before and 8.9% after). Subjects from both groups who completed the protocol had similar reductions in GERD symptom scores. Severe complications were rare (3 subjects receiving TF and 1 receiving the sham surgery). Conclusions TF was an effective treatment for patients with GERD symptoms, particularly in those with persistent regurgitation despite PPI therapy, based on evaluation 6 months after the procedure. Clinicaltrials.gov no: NCT01136980.

AB - Background & Aims Transoral esophagogastric fundoplication (TF) can decrease or eliminate features of gastroesophageal reflux disease (GERD) in some patients whose symptoms persist despite proton pump inhibitor (PPI) therapy. We performed a prospective, sham-controlled trial to determine if TF reduced troublesome regurgitation to a greater extent than PPIs in patients with GERD. Methods We screened 696 patients with troublesome regurgitation despite daily PPI use with 3 validated GERD-specific symptom scales, on and off PPIs. Those with at least troublesome regurgitation (based on the Montreal definition) on PPIs underwent barium swallow, esophagogastroduodenoscopy, 48-hour esophageal pH monitoring (off PPIs), and high-resolution esophageal manometry analyses. Patients with GERD and hiatal hernias ≤2 cm were randomly assigned to groups that underwent TF and then received 6 months of placebo (n = 87), or sham surgery and 6 months of once- or twice-daily omeprazole (controls, n = 42). Patients were blinded to therapy during follow-up period and reassessed at 2, 12, and 26 weeks. At 6 months, patients underwent 48-hour esophageal pH monitoring and esophagogastroduodenoscopy. Results By intention-to-treat analysis, TF eliminated troublesome regurgitation in a larger proportion of patients (67%) than PPIs (45%) (P =.023). A larger proportion of controls had no response at 3 months (36%) than subjects that received TF (11%; P =.004). Control of esophageal pH improved after TF (mean 9.3% before and 6.3% after; P <.001), but not after sham surgery (mean 8.6% before and 8.9% after). Subjects from both groups who completed the protocol had similar reductions in GERD symptom scores. Severe complications were rare (3 subjects receiving TF and 1 receiving the sham surgery). Conclusions TF was an effective treatment for patients with GERD symptoms, particularly in those with persistent regurgitation despite PPI therapy, based on evaluation 6 months after the procedure. Clinicaltrials.gov no: NCT01136980.

KW - Esophagus

KW - EsophyX

KW - Stomach

KW - TIF

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Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial

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