Incisionless operation for stomach ulcers may soon move into human trials

An incisionless operation to patch stomach ulcers and potentially other perforations in the digestive tract may soon move into human trials at the Mayo Clinic in Rochester, MN. Clinical investigators reported on their research experience at the 95th annual Clinical Congress of the American College of Surgeons.

"The problem we're looking at with perforated ulcer disease is that while it is not very frequent, the results for patients have not changed very much despite all the medications we have available to treat the disease," according to coauthor Juliane Bingener, MD, FACS. "Patients who have an ulcer do not do very well." Previous studies have reported that the incidence of severe ulcer disease has held steady despite the widespread use of antibiotics to counter the Helicobacter pylori bacteria linked to peptic ulcer symptoms. Approximately 30,000 Americans have operations for peptic ulcers yearly.

Perforated stomach ulcers typically require an operation to close the tear, but conventional open or minimally invasive surgical procedures can be problematic, particularly in seniors or younger patients with other health problems. The minimally invasive operation requires inflating the body cavity with carbon dioxide to create a large enough workspace for manipulating the surgical probes. This process raises pressure in the peritoneum, or abdominal cavity, and blood pressure with obvious consequences for people with other health problems or older patients. Those same individuals are most vulnerable to problems with the more invasive open-cavity operation.

The Mayo investigators used what is called an endoscopic approach, which involves the insertion of a scope with a suturing device into the stomach through the mouth to repair ulcers in laboratory pigs. Known as NOTES (natural orifice translumenal endoscopic surgery), this approach could be more tolerable for people who would have problems with the more conventional operations. "Our initial animal data suggests that we may not need quite as much peritoneal pressure with endoscopy," Dr. Bingener reported. "The advantage of lower pressure is more cardiovascular stability for the patient."

In Japan, where higher rates of stomach cancer exist, surgeons have a wider experience with the NOTES approach in humans. They have used NOTES to repair tears that can result from the removal of stomach tumors. The procedure involves using the inserted scope to pull up the omentum (abdominal tissue near the stomach) to patch the tear. Surgical clips hold the patch in place. The body passes the clips after approximately two weeks.

The Mayo investigators have received approval for using the NOTES repair in human volunteers. The first volunteers will initially undergo general anesthesia and have the procedure performed in an operating room. "In the future, if we can prove this technique works and have success with it, it can be done with less and less anesthesia, making the population that can undergo this procedure wider," said coauthor Erica A. Moran, MD. The procedure uses instruments already available in the typical operating room.