Stretta is a minimally invasive
endoscopic
An endoscopy is a procedure used in medicine to look inside the body. The endoscopy procedure uses an endoscope to examine the interior of a hollow organ or cavity of the body. Unlike many other medical imaging techniques, endoscopes are insert ...
procedure for the treatment of
gastroesophageal reflux disease
Gastroesophageal reflux disease (GERD) or gastro-oesophageal reflux disease (GORD) is one of the upper gastrointestinal chronic diseases where stomach content persistently and regularly flows up into the esophagus, resulting in symptoms and/ ...
(GERD) that delivers
radiofrequency energy in the form of
electromagnetic waves
In physics, electromagnetic radiation (EMR) consists of waves of the electromagnetic (EM) field, which propagate through space and carry momentum and electromagnetic radiant energy. It includes radio waves, microwaves, infrared, (visible) lig ...
through electrodes at the end of a
catheter
In medicine, a catheter (/ˈkæθətər/) is a thin tube made from medical grade materials serving a broad range of functions. Catheters are medical devices that can be inserted in the body to treat diseases or perform a surgical procedure. Cath ...
to the
lower esophageal sphincter
The esophagus (American English) or oesophagus (British English; both ), non-technically known also as the food pipe or gullet, is an organ in vertebrates through which food passes, aided by peristaltic contractions, from the pharynx to the ...
(LES) and the
gastric cardia – the region of the stomach just below the LES. The energy heats the tissue, ultimately causing it to swell and stiffen; the way this works was not understood as of 2015, but it was thought that perhaps the heat causes local inflammation, collagen deposition and muscular thickening of the LES and that it may
disrupt the nerves there.
History
Its relative efficacy is controversial, with the
American College of Gastroenterology
The American College of Gastroenterology (ACG) is a Bethesda, Maryland–based medical association of gastroenterologists.
The association was founded in 1932 and holds annual meetings and regional postgraduate continuing education courses, est ...
recommending against its use in 2013, and in the same year the
Society of American Gastrointestinal and Endoscopic Surgeons
The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) is a 501c6 non-profit professional organization providing education on gastrointestinal minimally invasive surgery. It describes itself thus: The mission of the Society of Ame ...
(SAGES) giving it a strong recommendation for people who refuse laparoscopic
Nissen fundoplication
A Nissen fundoplication, or laparoscopic Nissen fundoplication when performed via laparoscopic surgery, is a surgical procedure to treat gastroesophageal reflux disease (GERD) and hiatal hernia. In GERD, it is usually performed when medical thera ...
, which involves making incisions in the torso and wrapping part of the stomach around the base of the esophagus, and which is considered the gold standard for efficacy.
In 2015 an American Society for Gastrointestinal Endoscopy
The American Society for Gastrointestinal Endoscopy (ASGE) is a professional organization of physicians dedicated to improving endoscopy. The ASGE is made up largely of gastroenterologists from the United States. Included in its membership are en ...
guideline noted that the quality of evidence was low for Stretta and the other available endoscopic treatment for GERD (transoral incisionless fundoplication
Transoral incisionless fundoplication (TIF) is an endoscope treatment designed to relieve symptoms of gastroesophageal reflux disease (GERD). The TIF procedure, similar to Nissen fundoplication, alleviates GERD symptoms by wrapping a portion of the ...
) and called for better research to be conducted; it suggested that endoscopic treatments for GERD be considered.
The device for carrying out the procedure was originally developed by a company called Curon which obtained FDA approval for the device in 2000 but then went bankrupt in 2006; the device was brought back to market by Mederi Therapeutics in 2010.[ The procedure costs between $3,000 and $4,000 as of 2004.]
Evidence
An American Society of Gastrointestinal Endoscopy (ASGE) statement in June 2015 state that endoscopic antireflux therapy is a potential treatment based on the 2012 review.
In 2015 three reviews were published discussing the relative safety and effectiveness of the procedure compared with other endoscopic procedures delivered through the mouth, drug treatment (generally proton-pump inhibitors
Proton-pump inhibitors (PPIs) are a class of medications that cause a profound and prolonged reduction of stomach acid production. They do so by irreversibly inhibiting the stomach's H+/K+ ATPase proton pump.
They are the most potent inhibitors ...
), and fundoplication.
One was a systematic review and meta-analysis of clinical trials conducted with Stretta, done in response to the 2013 SAGES review (which did not include meta-analysis). This review found that quality of studies that had been conducted was generally poor, and that compared with sham therapy (used a placebo for medical device clinical trials), the procedure did not change time spent at a pH less than 4, did not increase lower esophageal sphincter pressure (LESP), did not allow people to stop treatment with proton-pump inhibitors, and did not improve health-related quality of life.[
Another of the 2015 reviews was a narrative ]literature review
A literature review is an overview of the previously published works on a topic. The term can refer to a full scholarly paper or a section of a scholarly work such as a book, or an article. Either way, a literature review is supposed to provid ...
, noted its long history of use, and found the procedure safe and effective, and noted that the procedure complemented drug treatment and fundoplication, providing a useful option.[
The other 2015 review was a narrative literature review was more tentative, noting the long safety record but only willing to state that the procedure "may be effective in reducing symptom burden and quality of life scores up to 8 years post-intervention. However, there does not appear to be any sustained improvement in objective outcomes and there is no evidence that Stretta results in improved outcomes as compared to surgical intervention.][
A more recent study published in 2020] evaluated 25 patients post Stretta Procedure and the results concluded significant improvement in reflux symptoms and quality of life, lowering Heartburn Score (DeMeester score) from 3.7 in women and 4.0 in men to 1.6±1 (p = 0.05) in women and 1.68±1.19 (p = 0.05) in men.
A 2012 systematic review and meta-analysis upon which the 2013 SAGES review had relied, had found that it improves GERD symptoms.
References
{{reflist, 32em
External links
WebMD: The Stretta Procedure to Treat GERD
Digestive system procedures
Endoscopy