Transoral endoscopic fundoplication in the treatment of gastroesophageal reflux disease

The anatomic and physiologic basis for reconstruction of the esophagogastric junction using a novel device

Blair A. Jobe, Robert W. O'Rourke, Barry P. McMahon, Flemming Gravesen, Cedric Lorenzo, John Hunter, Mary Bronner, Stefan J M Kraemer

Research output: Contribution to journalArticle

43 Citations (Scopus)

Abstract

OBJECTIVE:: To determine the safety, mechanism of action, immediate postprocedural anatomic impact on the esophagogastric junction, and short-term efficacy of the first entirely endolumenal antireflux procedure. BACKGROUND:: A safe and effective endoscopic antireflux procedure remains elusive. Transoral endolumenal surgery has enormous potential for the treatment of gastroesophageal reflux disease (GERD) and other esophagogastric diseases. A canine model was used to study a novel endoscopic device, which allows for creation of an endoluminal fundoplication. METHODS:: The transoral incisionless fundoplication (TIF) was performed in 21 canines in a phase I feasibility and safety study, and in 21 canines in a phase II study that included a detailed objective assessment of the effects of 2 variants of the TIF procedure (TIF 1.0 and TIF 2.0) versus sham on esophageal physiology and esophagogastric junction (EGJ) anatomy. RESULTS:: In phase I, TIF provided a safe and feasible endolumenal therapy for GERD, with histologic data that demonstrated serosal fusion of approximated full-thickness tissue plications and durability of the fundoplication. TIF procedures effectively reduced cardia circumference and improved Hill classification grade. In phase II, the TIF 2.0 procedure achieved normalization of distal esophageal acid exposure and increased lower esophageal sphincter (LES) pressure and length based on objective testing over a 2-week period. TIF 2.0 demonstrated superior results to TIF 1.0, and valve appearance and location exhibited similarity to the Nissen fundoplication by vector volume analysis. CONCLUSIONS:: The TIF procedure is safe and results in a durable and functional fundoplication as well as a platform for further development and modification of the procedure, which can be use to impact outcome. This work provides the foundation for human translation and assessment of long-term outcomes.

Original languageEnglish (US)
Pages (from-to)69-76
Number of pages8
JournalAnnals of Surgery
Volume248
Issue number1
DOIs
StatePublished - Jul 2008

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Esophagogastric Junction
Fundoplication
Gastroesophageal Reflux
Equipment and Supplies
Canidae
Safety
Lower Esophageal Sphincter
Cardia
Feasibility Studies

ASJC Scopus subject areas

  • Surgery

Cite this

Transoral endoscopic fundoplication in the treatment of gastroesophageal reflux disease : The anatomic and physiologic basis for reconstruction of the esophagogastric junction using a novel device. / Jobe, Blair A.; O'Rourke, Robert W.; McMahon, Barry P.; Gravesen, Flemming; Lorenzo, Cedric; Hunter, John; Bronner, Mary; Kraemer, Stefan J M.

In: Annals of Surgery, Vol. 248, No. 1, 07.2008, p. 69-76.

Research output: Contribution to journalArticle

Jobe, Blair A. ; O'Rourke, Robert W. ; McMahon, Barry P. ; Gravesen, Flemming ; Lorenzo, Cedric ; Hunter, John ; Bronner, Mary ; Kraemer, Stefan J M. / Transoral endoscopic fundoplication in the treatment of gastroesophageal reflux disease : The anatomic and physiologic basis for reconstruction of the esophagogastric junction using a novel device. In: Annals of Surgery. 2008 ; Vol. 248, No. 1. pp. 69-76.
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abstract = "OBJECTIVE:: To determine the safety, mechanism of action, immediate postprocedural anatomic impact on the esophagogastric junction, and short-term efficacy of the first entirely endolumenal antireflux procedure. BACKGROUND:: A safe and effective endoscopic antireflux procedure remains elusive. Transoral endolumenal surgery has enormous potential for the treatment of gastroesophageal reflux disease (GERD) and other esophagogastric diseases. A canine model was used to study a novel endoscopic device, which allows for creation of an endoluminal fundoplication. METHODS:: The transoral incisionless fundoplication (TIF) was performed in 21 canines in a phase I feasibility and safety study, and in 21 canines in a phase II study that included a detailed objective assessment of the effects of 2 variants of the TIF procedure (TIF 1.0 and TIF 2.0) versus sham on esophageal physiology and esophagogastric junction (EGJ) anatomy. RESULTS:: In phase I, TIF provided a safe and feasible endolumenal therapy for GERD, with histologic data that demonstrated serosal fusion of approximated full-thickness tissue plications and durability of the fundoplication. TIF procedures effectively reduced cardia circumference and improved Hill classification grade. In phase II, the TIF 2.0 procedure achieved normalization of distal esophageal acid exposure and increased lower esophageal sphincter (LES) pressure and length based on objective testing over a 2-week period. TIF 2.0 demonstrated superior results to TIF 1.0, and valve appearance and location exhibited similarity to the Nissen fundoplication by vector volume analysis. CONCLUSIONS:: The TIF procedure is safe and results in a durable and functional fundoplication as well as a platform for further development and modification of the procedure, which can be use to impact outcome. This work provides the foundation for human translation and assessment of long-term outcomes.",
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AB - OBJECTIVE:: To determine the safety, mechanism of action, immediate postprocedural anatomic impact on the esophagogastric junction, and short-term efficacy of the first entirely endolumenal antireflux procedure. BACKGROUND:: A safe and effective endoscopic antireflux procedure remains elusive. Transoral endolumenal surgery has enormous potential for the treatment of gastroesophageal reflux disease (GERD) and other esophagogastric diseases. A canine model was used to study a novel endoscopic device, which allows for creation of an endoluminal fundoplication. METHODS:: The transoral incisionless fundoplication (TIF) was performed in 21 canines in a phase I feasibility and safety study, and in 21 canines in a phase II study that included a detailed objective assessment of the effects of 2 variants of the TIF procedure (TIF 1.0 and TIF 2.0) versus sham on esophageal physiology and esophagogastric junction (EGJ) anatomy. RESULTS:: In phase I, TIF provided a safe and feasible endolumenal therapy for GERD, with histologic data that demonstrated serosal fusion of approximated full-thickness tissue plications and durability of the fundoplication. TIF procedures effectively reduced cardia circumference and improved Hill classification grade. In phase II, the TIF 2.0 procedure achieved normalization of distal esophageal acid exposure and increased lower esophageal sphincter (LES) pressure and length based on objective testing over a 2-week period. TIF 2.0 demonstrated superior results to TIF 1.0, and valve appearance and location exhibited similarity to the Nissen fundoplication by vector volume analysis. CONCLUSIONS:: The TIF procedure is safe and results in a durable and functional fundoplication as well as a platform for further development and modification of the procedure, which can be use to impact outcome. This work provides the foundation for human translation and assessment of long-term outcomes.

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