Perendoscopic GERD Therapies

Several endoscopic devices have been developed and used to treat GERD patients during the past 4 years. The current perendoscopic devices and vendors are listed in Table 13-1. Despite considerable numbers of procedures performed to date, endoscopic treatment modalities for GERD have escaped the scrutiny of carefully designed, randomized, sham studies to critically evaluate their efficacy. Patient treatment groups have been carefully selected to avoid the majority of GERD sufferers with severe problems. Head-to-head studies comparing endoscopic GERD treatment with currently accepted treatment modalities for reflux disease are lacking. Factors to consider in the endoscopic treatment of GERD are shown in Table 13-2. Clinical outcome results of endoscopic GERD treatments have been determined almost exclusively on the basis of short-term, open-label trials. There has been a paucity of peer-reviewed publications. Finally, concerns about the safety, durability and cost-effectiveness of endo-scopic GERD therapy have yet to be adequately answered.

Despite these imposing, critical issues, the number of new endoscopic devices introduced as treatment options for GERD is growing. Premarketing guidelines for future devices for GERD therapy are shown in Table 13-3. At present, perendoscopic GERD treatment modalities have been designed to augment the reflux barrier based on one of the

TABLE 13-1. Endoscopic Devices for Gastroesophageal Reflux Disease Therapy

Device

Vendor

Antireflux Mechanism

Approval

Stretta

Curon Medical Inc, Sunnyvale, CA RF thermal energy

Yes

Endocinch

CR Bard, Inc, Murray Hill, NJ

Sewing/plication

Yes

ESD

Wilson-Cook Med, Inc, Winston-Salem, NC

Sewing/plication

Yes

Enteryx

Boston Scientific, Natick, MA

Injection biopolymer

Yes

Plexiglass

Rohn & Haas, Philadelphia, PA

Injection biopolymer

No

Plicator

NDO Surgical Inc, Mansfield, MA

Plication technique

No

Gatekeeper Medtronic, Minneapolis, MN

Implantable biopolymer

No

FDA = US Food and Drug Administration; RF = radiofrequency.

FDA = US Food and Drug Administration; RF = radiofrequency.

TABLE 13-2. Factors in Endoscopic Therapy for Gastroesophageal Reflux Disease

• Esophagus: Vigorous contractions; longitudinal, shortening; GEJ angulation; wall thickness

• Procedure: Large diameter overtubes; blinded balloon inflations/needle deployment; injections/placement of foreign polymers; instrument impaction

• Anesthesia: Increased amount conscious sedation; general infrequently

• Competence: Adequate training and experience with device/technique

GEJ = gastroesophageal junction.

TABLE 13-3. Future Endoscopic Gastroesophageal Reflux Disease Devices Premarketing Guidelines

• Stringent FDA assessment for approval

• Mandatory sham, controlled trials

• Assured safety of device/procedure

• Longevity of therapeutic benefit

• Comparisons to conventional treatments

• Applicability to all GERD patients

• Cost-effectiveness treatment modality

FDA = US Food and Drug Administration; GERD = gastroesophageal reflux disease.

following three general techniques: (1) radiofrequency (RF) thermal energy, (2) sewing or plication, and (3) injectable or implantable biopolymers. A review of these sophisticated technologies and procedures is necessary to gain an appropriate perspective into the current and future role for this approach to GERD management.

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Responses

  • dieter
    What is GEJ angulation?
    8 years ago

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