麻豆传媒

Pyloroplasty paired with gastric electrical stimulation (GES) was more effective than surgery alone for controlling gastroparesis symptoms, a randomized trial indicated.

All patients in the 30-patient double-blind study had a GES device implanted during pyloroplasty, but those who had their stimulation turned on had a greater reduction in mean Gastroparesis Cardinal Symptom Index () total score from at 3 months versus pyloroplasty with no stimulation (P<0.05):

• Pyloroplasty plus stimulation: 19.3 at baseline to 7.9 at 3 months
• Pyloroplasty alone: 17.9 to 11.3

A greater reduction in mean vomiting scores was also observed in the stimulation group from baseline to 3 months (3.3 to 1.1), versus the control group (3.3 to 2.1; P=0.02), and the stimulation group experienced fewer hospitalizations caused by vomiting, reported Irene Sarosiek, MD, of Texas Tech University Health Sciences Center in El Paso, at the American College of Gastroenterology annual meeting.

The findings represent the first double-blind study to demonstrate that adding stimulation with Enterra GES is more effective than pyloroplasty alone, Sarosiek said, particularly when it comes to vomiting scores.

"This is very important clinically," she said, adding that "pyloroplasty significantly accelerated gastric emptying in both groups."

Gastric emptying was normalized at 4 months in 38% of the stimulation group and 40% of controls.

After 3 months, an unblinded phase began where all patients had stimulation for another 3-month study period. When GES was turned on for the control group, they experienced improved 6-month GCSI scores that were similar to the initial stimulation group.

Enterra GES is an FDA approved therapy, under a , for chronic drug refractory nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology. In the study, 24 of the 30 patients had gastroparesis of diabetic etiology.

Michael Cline, DO, of the Cleveland Clinic in Ohio, told 麻豆传媒 that the trial enrolled a typical gastroparesis patient population, though he cautioned about the small sample size.

The findings suggest that if a surgical intervention is being considered, "the two procedures together would be the best approach," said Cline, who was not involved in the research. "The main issue here is that centers are moving away from the invasive procedures to the minimally invasive endoscopic pyloromyotomy, which makes this study somewhat difficult to employ in day-to-day treatment."

Gastroparesis has been suggested to be correlated with the reduction of interstitial cells of Cajal in the pyloric smooth muscle of the stomach, explained Sarosiek during her presentation. These pacemaker cells may increase fibrosis and potentially result in pyloric dysfunction.

The study enrolled patients with drug-refractory gastroparesis, all of whom underwent pyloroplasty with a simultaneous surgical implantation of Medtronic's Enterra Therapy Itrel III GES system. Patients were then randomized 1:1 to receive active gastric electrical stimulation for 3 months after surgery or no stimulation.

"GES and pyloroplasty can be accomplished very safely at the same time, with no technical and surgical complications," said Sarosiek.

Patients had a median age of 46 years, and 60% were women. Eligible patients were required to have gastroparesis for at least 1 year (mean 5.6), a minimum of seven vomiting episodes per week, and a negative esophagogastroduodenoscopy test result.

At baseline, both groups showed a similar delayed gastric emptying on the 4-hour scintigraphic gastric emptying test, with over a 10% retention rate.

From baseline to 3 months, GCSI scores for all individual symptoms significantly decreased in the stimulation group (nausea, vomiting, early satiety, bloating, fullness, abdominal pain). In the control group, only nausea significantly decreased.

No complications or technical dysfunctions occurred after surgery, though two patients experienced a dislodgement of electrodes that required a replacement of GES leads. One patient died from cardiovascular problems, a complication of diabetes, said Sarosiek.

Comment