Gastroesophageal reflux disease, also known as GERD, is common, costly, and often chronic. For some people, it may mean taking medications for long periods of time. For others, surgery may be required to get long-lasting relief.
What is GERD?
GERD occurs when the lower esophageal sphincter becomes lax and allows moderate to large amounts of acidic stomach contents to regurgitate (reflux) into the esophagus. This causes esophageal inflammation (esophagitis) and, sometimes, ulcerations, scarring (strictures), and a variety of non-gastrointestinal symptoms, such as a chronic cough and asthma.
It can also be associated with the development of Barrett’s esophagus, a condition where the lining of the esophagus responds to the chronic irritation by transforming its cell type to one that more closely resembles that of the lining of the intestine. The reason why this is important is that Barrett’s esophagus is considered a risk factor for the development of an uncommon, but potentially deadly form of cancer – esophageal adenocarcinoma.
Traditional approaches to treatment
Before we explore the pros and cons of incisionless surgery for GERD, here’s a quick review of traditional approaches to the treatment of the disease.
Some people with GERD can control their symptoms with lifestyle changes, such as avoiding fried foods, alcohol, not going to sleep right after a big meal or losing weight. However, many will resort to medications – often proton pump inhibitors or PPIs.
Although prescription or over-the-counter PPIs are often taken for very long periods of time, significant risks related to taking the medication for longer than it was originally intended have been reported in the medical literature. These include (amongst others):
- Vitamin B12 deficiency[i]
- Increased risk of C.difficile[ii]
- Chronic kidney disease[iii]
- Cardiovascular disease[iv]
- Increased risk of osteoporosis fractures[v]
Further, although PPIs reduce the acidity of the regurgitated stomach contents, they do not address the underlying cause of the reflux – that is, the abnormally functioning lower esophageal sphincter (LES).
Surgical correction of a lax LES has been an accepted alternative to treat chronic GERD for many years. However, whether done by an open procedure (Nissen fundoplication) or by laparoscopy (laparoscopic Nissen fundoplication), it is a big operation that may leave patients with some unpleasant symptoms, such the inability to belch or vomit, difficulty swallowing, bloating, and an increase in flatulence.
A Non-Medication, Non-Surgical Incisionless Alternative
I recently met with Skip Baldino, the President and CEO of EndoGastric Solutions. I wanted to learn about his company’s innovative non-medication, non-surgical incisionless alternative for the treatment of GERD. According to their literature, the company is “a medical device company focused on developing and commercializing innovative, evidence-based, non-invasive surgical technology for the treatment of GERD.”
Their product, the EsophyX device, is used with a standard endoscope (for direct visualization) and inserted through the mouth to rebuild the LES using traditional surgical principles. To understand how it works, we need to first review the principles of fundoplication.
What is a fundoplication?
Fundoplication is a surgical procedure that involves wrapping and then sewing the upper part of the stomach (called the fundus) around the lower esophagus in a way that causes the esophagus to pass through a small tunnel created out of stomach muscle. This strengthens the lax LES and makes it more difficult for acidic stomach contents to back up into the esophagus.
The open procedure (Nissen fundoplication) is done by making a large incision in either the abdomen or the chest. The laparoscopic technique (laparoscopic Nissen fundoplication) is performed without making large incisions. Instead, the surgeon inserts a camera and various instruments through small incisions in the abdomen.