Endoscopic augmentation of the cardia with a biocompatible injectable polymer (Enteryx) in a porcine model

R. J. Mason, M. Hughes, Glen Lehman, G. Chiao, J. Deviere, D. E. Silverman, T. R. DeMeester, J. H. Peters

Research output: Contribution to journalArticle

73 Citations (Scopus)

Abstract

Background: Endoscopic approaches to restore the gastroesophageal barrier in patients with gastroesophageal reflux disease (GERD) are presently undergoing clinical trial. The aim of the study was to demonstrate the feasibility, durability, safety, and antireflux efficacy following augmentation of the cardia with a biocompatible injectable polymer (Enteryx). Methods: Augmentation was performed in 12 Yucatan mini-pigs. The cardia was injected circumferentially with 1-1.5 ml of Enteryx at three or four sites. Four groups of three animals each were killed at 2, 6, 12, and 24 weeks following augmentation. Gastrointestinal endoscopy and esophageal manometry were performed preoperatively and postoperatively. Competency was determined as the intragastric pressure (yield pressure) and volume (yield volume) needed during gastric distension with air and water to result in equalization of gastric and esophageal pressure. Comparisons were made with a group of noninjected animals (n = 6). Results: All animals had a normal eating pattern; none showed any evidence of vomiting or regurgitation. The median injection volume was 4 ml (range, 1-8). At autopsy, implants were found in 83% of the animals. Intramuscular placement of the implant was durable, whereas sloughing occurred if the implant was placed submucosally. The mechanical properties of sphincter length and pressure were unaffected by the injection. The median yield pressure of the animals that survived for >6 weeks (21.4 mmHg) was significantly greater (p = 0.049) than the animals that survived for <6 weeks (4.5 mmHg) and greater (p = 0.054) than the control animals (9.1 mmHg), suggesting that the healing process was associated with reduced distensibility of the cardia. Conclusions: Augmentation of the cardia with an injectable polymer (Enteryx) is simple, safe, and durable. Early studies suggest that alteration in the distensibility and geometry of the gastroesophageal junction may provide antireflux protection.

Original languageEnglish
Pages (from-to)386-391
Number of pages6
JournalSurgical Endoscopy and Other Interventional Techniques
Volume16
Issue number3
DOIs
StatePublished - 2002

Fingerprint

Cardia
Polymers
Swine
Injections
Pressure
Stomach
Esophagogastric Junction
Gastrointestinal Endoscopy
Manometry
Gastroesophageal Reflux
ethylene-vinyl alcohol copolymer
Vomiting
Autopsy
Eating
Air
Clinical Trials
Safety
Water

Keywords

  • Cardia
  • Endoscopy
  • Gastroesophageal reflux disease
  • Lower esophageal sphincter augmentation
  • Porcine model

ASJC Scopus subject areas

  • Surgery

Cite this

Endoscopic augmentation of the cardia with a biocompatible injectable polymer (Enteryx) in a porcine model. / Mason, R. J.; Hughes, M.; Lehman, Glen; Chiao, G.; Deviere, J.; Silverman, D. E.; DeMeester, T. R.; Peters, J. H.

In: Surgical Endoscopy and Other Interventional Techniques, Vol. 16, No. 3, 2002, p. 386-391.

Research output: Contribution to journalArticle

Mason, R. J. ; Hughes, M. ; Lehman, Glen ; Chiao, G. ; Deviere, J. ; Silverman, D. E. ; DeMeester, T. R. ; Peters, J. H. / Endoscopic augmentation of the cardia with a biocompatible injectable polymer (Enteryx) in a porcine model. In: Surgical Endoscopy and Other Interventional Techniques. 2002 ; Vol. 16, No. 3. pp. 386-391.
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T1 - Endoscopic augmentation of the cardia with a biocompatible injectable polymer (Enteryx) in a porcine model

AU - Mason, R. J.

AU - Hughes, M.

AU - Lehman, Glen

AU - Chiao, G.

AU - Deviere, J.

AU - Silverman, D. E.

AU - DeMeester, T. R.

AU - Peters, J. H.

PY - 2002

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N2 - Background: Endoscopic approaches to restore the gastroesophageal barrier in patients with gastroesophageal reflux disease (GERD) are presently undergoing clinical trial. The aim of the study was to demonstrate the feasibility, durability, safety, and antireflux efficacy following augmentation of the cardia with a biocompatible injectable polymer (Enteryx). Methods: Augmentation was performed in 12 Yucatan mini-pigs. The cardia was injected circumferentially with 1-1.5 ml of Enteryx at three or four sites. Four groups of three animals each were killed at 2, 6, 12, and 24 weeks following augmentation. Gastrointestinal endoscopy and esophageal manometry were performed preoperatively and postoperatively. Competency was determined as the intragastric pressure (yield pressure) and volume (yield volume) needed during gastric distension with air and water to result in equalization of gastric and esophageal pressure. Comparisons were made with a group of noninjected animals (n = 6). Results: All animals had a normal eating pattern; none showed any evidence of vomiting or regurgitation. The median injection volume was 4 ml (range, 1-8). At autopsy, implants were found in 83% of the animals. Intramuscular placement of the implant was durable, whereas sloughing occurred if the implant was placed submucosally. The mechanical properties of sphincter length and pressure were unaffected by the injection. The median yield pressure of the animals that survived for >6 weeks (21.4 mmHg) was significantly greater (p = 0.049) than the animals that survived for <6 weeks (4.5 mmHg) and greater (p = 0.054) than the control animals (9.1 mmHg), suggesting that the healing process was associated with reduced distensibility of the cardia. Conclusions: Augmentation of the cardia with an injectable polymer (Enteryx) is simple, safe, and durable. Early studies suggest that alteration in the distensibility and geometry of the gastroesophageal junction may provide antireflux protection.

AB - Background: Endoscopic approaches to restore the gastroesophageal barrier in patients with gastroesophageal reflux disease (GERD) are presently undergoing clinical trial. The aim of the study was to demonstrate the feasibility, durability, safety, and antireflux efficacy following augmentation of the cardia with a biocompatible injectable polymer (Enteryx). Methods: Augmentation was performed in 12 Yucatan mini-pigs. The cardia was injected circumferentially with 1-1.5 ml of Enteryx at three or four sites. Four groups of three animals each were killed at 2, 6, 12, and 24 weeks following augmentation. Gastrointestinal endoscopy and esophageal manometry were performed preoperatively and postoperatively. Competency was determined as the intragastric pressure (yield pressure) and volume (yield volume) needed during gastric distension with air and water to result in equalization of gastric and esophageal pressure. Comparisons were made with a group of noninjected animals (n = 6). Results: All animals had a normal eating pattern; none showed any evidence of vomiting or regurgitation. The median injection volume was 4 ml (range, 1-8). At autopsy, implants were found in 83% of the animals. Intramuscular placement of the implant was durable, whereas sloughing occurred if the implant was placed submucosally. The mechanical properties of sphincter length and pressure were unaffected by the injection. The median yield pressure of the animals that survived for >6 weeks (21.4 mmHg) was significantly greater (p = 0.049) than the animals that survived for <6 weeks (4.5 mmHg) and greater (p = 0.054) than the control animals (9.1 mmHg), suggesting that the healing process was associated with reduced distensibility of the cardia. Conclusions: Augmentation of the cardia with an injectable polymer (Enteryx) is simple, safe, and durable. Early studies suggest that alteration in the distensibility and geometry of the gastroesophageal junction may provide antireflux protection.

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KW - Lower esophageal sphincter augmentation

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