Endoscopic, deep mural implantation of enteryx for the treatment of GERD: 6-Month follow-up of a multicenter trial

David A. Johnson, Robert Ganz, James Aisenberg, Lawrence B. Cohen, Jacques Deviere, T. Raymond Foley, Gregory B. Haber, Jeffrey H. Peters, Glen Lehman

Research output: Contribution to journalArticle

98 Citations (Scopus)

Abstract

OBJECTIVES: This prospective, multicenter, single-arm study evaluated the safety and efficacy of the endoscopic implantation of Enteryx, a biocompatible, non-biodegradable liquid polymer for the treatment of GERD. METHODS: Eighty-five patients with heartburn symptoms responsive to proton pump inhibitor (PPI) use were enrolled. Inclusion requirements were HRQL score ≤ 11 on PPI and ≥ 20 off PPI, and 24-hour PH probe with ≥ 5% total time at PH ≤ 4. Patients with a hiatus hernia > 3 cm, grade 3 or 4 esophagitis, or esophageal motility disorder were excluded. Using a 4-mm needle tipped catheter during standard endoscopy, implants were made in 3-4 quadrants deep into the wall of the cardia. Use of PPI medications, pH-metry, manometry, GERD symptoms, and patient quality of life were assessed over a 6-month follow-up period. RESULTS: At 6 months, PPI use was eliminated in 74% and reduced by > 50% in 10% of patients. The median HRQL score improved from 24.0 pre-implant (baseline off PPIs) to 4.0 at 6 months (p <0.001). Mean total esophageal acid exposure time was 9.5% pretherapy and 6.7% at 6 months (p <0.001). Mean LES length increased from 2.0 cm at baseline to 3.0 cm posttherapy (p = 0.003). There were no clinically serious adverse events. Transient mild-to-moderate chest pain commonly occurred after implantation. CONCLUSIONS: The endoscopic implantation of Enteryx is a safe and effective therapy for eliminating or decreasing the need for PPI medications, improving GERD symptoms and patient quality of life, and decreasing esophageal acid exposure among patients suffering from GERD.

Original languageEnglish (US)
Pages (from-to)250-258
Number of pages9
JournalAmerican Journal of Gastroenterology
Volume98
Issue number2
DOIs
StatePublished - 2003
Externally publishedYes

Fingerprint

Proton Pump Inhibitors
Gastroesophageal Reflux
Multicenter Studies
Therapeutics
Quality of Life
Esophageal Motility Disorders
Heartburn
Cardia
Hiatal Hernia
Acids
Esophagitis
Manometry
Chest Pain
Endoscopy
Needles
ethylene-vinyl alcohol copolymer
Polymers
Catheters
Safety

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Endoscopic, deep mural implantation of enteryx for the treatment of GERD : 6-Month follow-up of a multicenter trial. / Johnson, David A.; Ganz, Robert; Aisenberg, James; Cohen, Lawrence B.; Deviere, Jacques; Foley, T. Raymond; Haber, Gregory B.; Peters, Jeffrey H.; Lehman, Glen.

In: American Journal of Gastroenterology, Vol. 98, No. 2, 2003, p. 250-258.

Research output: Contribution to journalArticle

Johnson, David A. ; Ganz, Robert ; Aisenberg, James ; Cohen, Lawrence B. ; Deviere, Jacques ; Foley, T. Raymond ; Haber, Gregory B. ; Peters, Jeffrey H. ; Lehman, Glen. / Endoscopic, deep mural implantation of enteryx for the treatment of GERD : 6-Month follow-up of a multicenter trial. In: American Journal of Gastroenterology. 2003 ; Vol. 98, No. 2. pp. 250-258.
@article{b3080e3d871c47a990c777ce2b080058,
title = "Endoscopic, deep mural implantation of enteryx for the treatment of GERD: 6-Month follow-up of a multicenter trial",
abstract = "OBJECTIVES: This prospective, multicenter, single-arm study evaluated the safety and efficacy of the endoscopic implantation of Enteryx, a biocompatible, non-biodegradable liquid polymer for the treatment of GERD. METHODS: Eighty-five patients with heartburn symptoms responsive to proton pump inhibitor (PPI) use were enrolled. Inclusion requirements were HRQL score ≤ 11 on PPI and ≥ 20 off PPI, and 24-hour PH probe with ≥ 5{\%} total time at PH ≤ 4. Patients with a hiatus hernia > 3 cm, grade 3 or 4 esophagitis, or esophageal motility disorder were excluded. Using a 4-mm needle tipped catheter during standard endoscopy, implants were made in 3-4 quadrants deep into the wall of the cardia. Use of PPI medications, pH-metry, manometry, GERD symptoms, and patient quality of life were assessed over a 6-month follow-up period. RESULTS: At 6 months, PPI use was eliminated in 74{\%} and reduced by > 50{\%} in 10{\%} of patients. The median HRQL score improved from 24.0 pre-implant (baseline off PPIs) to 4.0 at 6 months (p <0.001). Mean total esophageal acid exposure time was 9.5{\%} pretherapy and 6.7{\%} at 6 months (p <0.001). Mean LES length increased from 2.0 cm at baseline to 3.0 cm posttherapy (p = 0.003). There were no clinically serious adverse events. Transient mild-to-moderate chest pain commonly occurred after implantation. CONCLUSIONS: The endoscopic implantation of Enteryx is a safe and effective therapy for eliminating or decreasing the need for PPI medications, improving GERD symptoms and patient quality of life, and decreasing esophageal acid exposure among patients suffering from GERD.",
author = "Johnson, {David A.} and Robert Ganz and James Aisenberg and Cohen, {Lawrence B.} and Jacques Deviere and Foley, {T. Raymond} and Haber, {Gregory B.} and Peters, {Jeffrey H.} and Glen Lehman",
year = "2003",
doi = "10.1111/j.1572-0241.2003.07291.x",
language = "English (US)",
volume = "98",
pages = "250--258",
journal = "American Journal of Gastroenterology",
issn = "0002-9270",
publisher = "Nature Publishing Group",
number = "2",

}

TY - JOUR

T1 - Endoscopic, deep mural implantation of enteryx for the treatment of GERD

T2 - 6-Month follow-up of a multicenter trial

AU - Johnson, David A.

AU - Ganz, Robert

AU - Aisenberg, James

AU - Cohen, Lawrence B.

AU - Deviere, Jacques

AU - Foley, T. Raymond

AU - Haber, Gregory B.

AU - Peters, Jeffrey H.

AU - Lehman, Glen

PY - 2003

Y1 - 2003

N2 - OBJECTIVES: This prospective, multicenter, single-arm study evaluated the safety and efficacy of the endoscopic implantation of Enteryx, a biocompatible, non-biodegradable liquid polymer for the treatment of GERD. METHODS: Eighty-five patients with heartburn symptoms responsive to proton pump inhibitor (PPI) use were enrolled. Inclusion requirements were HRQL score ≤ 11 on PPI and ≥ 20 off PPI, and 24-hour PH probe with ≥ 5% total time at PH ≤ 4. Patients with a hiatus hernia > 3 cm, grade 3 or 4 esophagitis, or esophageal motility disorder were excluded. Using a 4-mm needle tipped catheter during standard endoscopy, implants were made in 3-4 quadrants deep into the wall of the cardia. Use of PPI medications, pH-metry, manometry, GERD symptoms, and patient quality of life were assessed over a 6-month follow-up period. RESULTS: At 6 months, PPI use was eliminated in 74% and reduced by > 50% in 10% of patients. The median HRQL score improved from 24.0 pre-implant (baseline off PPIs) to 4.0 at 6 months (p <0.001). Mean total esophageal acid exposure time was 9.5% pretherapy and 6.7% at 6 months (p <0.001). Mean LES length increased from 2.0 cm at baseline to 3.0 cm posttherapy (p = 0.003). There were no clinically serious adverse events. Transient mild-to-moderate chest pain commonly occurred after implantation. CONCLUSIONS: The endoscopic implantation of Enteryx is a safe and effective therapy for eliminating or decreasing the need for PPI medications, improving GERD symptoms and patient quality of life, and decreasing esophageal acid exposure among patients suffering from GERD.

AB - OBJECTIVES: This prospective, multicenter, single-arm study evaluated the safety and efficacy of the endoscopic implantation of Enteryx, a biocompatible, non-biodegradable liquid polymer for the treatment of GERD. METHODS: Eighty-five patients with heartburn symptoms responsive to proton pump inhibitor (PPI) use were enrolled. Inclusion requirements were HRQL score ≤ 11 on PPI and ≥ 20 off PPI, and 24-hour PH probe with ≥ 5% total time at PH ≤ 4. Patients with a hiatus hernia > 3 cm, grade 3 or 4 esophagitis, or esophageal motility disorder were excluded. Using a 4-mm needle tipped catheter during standard endoscopy, implants were made in 3-4 quadrants deep into the wall of the cardia. Use of PPI medications, pH-metry, manometry, GERD symptoms, and patient quality of life were assessed over a 6-month follow-up period. RESULTS: At 6 months, PPI use was eliminated in 74% and reduced by > 50% in 10% of patients. The median HRQL score improved from 24.0 pre-implant (baseline off PPIs) to 4.0 at 6 months (p <0.001). Mean total esophageal acid exposure time was 9.5% pretherapy and 6.7% at 6 months (p <0.001). Mean LES length increased from 2.0 cm at baseline to 3.0 cm posttherapy (p = 0.003). There were no clinically serious adverse events. Transient mild-to-moderate chest pain commonly occurred after implantation. CONCLUSIONS: The endoscopic implantation of Enteryx is a safe and effective therapy for eliminating or decreasing the need for PPI medications, improving GERD symptoms and patient quality of life, and decreasing esophageal acid exposure among patients suffering from GERD.

UR - http://www.scopus.com/inward/record.url?scp=0037285702&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0037285702&partnerID=8YFLogxK

U2 - 10.1111/j.1572-0241.2003.07291.x

DO - 10.1111/j.1572-0241.2003.07291.x

M3 - Article

C2 - 12591037

AN - SCOPUS:0037285702

VL - 98

SP - 250

EP - 258

JO - American Journal of Gastroenterology

JF - American Journal of Gastroenterology

SN - 0002-9270

IS - 2

ER -