Innovative Endoscopy Procedure for Gastroparesis Is Safe and Feasible

Gastroparesis, delayed gastric emptying in the absence of mechanical obstruction, is a debilitating and chronic digestive disease affecting 5 million people in the U.S. Typically, medical therapies, intrapyloric injections of botulinum toxin, gastric electrical stimulation therapy and surgical open or laparoscopic pyloroplasty are utilized to manage the disease.

Still, it is a frustrating condition for patients and physicians alike, and until recently these medical and surgical procedures have been largely unsuccessful in resolving the disease’s symptoms or have been associated with complications. According to Cleveland Clinic general surgeon John H. Rodriguez, MD, however, a new, minimally invasive endoscopy therapy, per oral endoscopic pyloromyotomy (POP), has recently shown great promise as an alternative to surgical pyloroplasty for these patients.

Dr. Rodriguez explains that POP has been described in small case reports since 2013 and was first performed at Cleveland Clinic in January 2016. Since that time, he and his colleagues have conducted a prospective study of the technique, and recently published results in Surgical Endoscopy on the first 47 subjects (although to date they have performed almost 100 cases).

The POP study design

From January 2016 to January 2017, prospective patients who were suspected of having gastroparesis were evaluated by a multidisciplinary team comprised of a psychiatrist, dietitian, gastroenterologist and four surgeons specializing in minimally invasive techniques. Prior to having the procedure, a four-hour, non-extrapolated gastric-emptying scintigraphy study was performed on all subjects, who subjectively rated their symptoms on the Gastroparesis Cardinal Symptom Index (GCSI). Subjects repeated the GCSI at three months after POP.

Of the 47 patients, 27 (57.4 percent) were classified as having idiopathic gastroparesis, 12 (25.6 percent) as having diabetic gastroparesis and eight (17 percent) as having postsurgical gastroparesis. The majority of the patients (87.2 percent) had been treated with one or more previous interventions for their symptoms, such as placement of an enteral feeding tube or a gastric pacer or botulinum toxin injection.

The POP procedure was performed in the operating room under general anesthesia. Patients stayed in the hospital overnight after the POP procedure and an upper gastrointestinal (GI) series was performed to assess emptying through the pylorus and to check for unrecognized perforations. At discharge, patients were instructed to follow a liquid diet for two weeks and to take anti-acid therapies (sucralfate and a proton pump inhibitor) for four weeks. A repeat gastric-emptying study was performed at three months post-procedure.

The POP procedure produced statistically significant objective and subjective improvements in gastroparesis symptoms at 30 days and three months after treatment. Prior to the procedure, the average percentage of retained food at four hours was 37 percent and the average GCSI score was 4.6. After POP, the retained food percentage was reduced to 20 percent and the GCSI score to 3.3.

One patient died within 30 days of the POP procedure, but his death was unrelated to the surgery. “The procedure is very safe,” says Dr. Rodriguez, “and there were no procedure-related adverse events, including gastric or duodenal ulcer, intraluminal hemorrhage or gastric dumping syndrome.” There were also no repeat surgeries or hospitalizations related to the POP procedure.

A first-line treatment option

“This procedure has dramatically changed our practice at the Cleveland Clinic, and has become our first-line treatment option for medically refractive gastroparesis in well-selected patients,” Dr. Rodriguez says.

According to Matthew D. Kroh, MD, head of the research group and Chief of the Digestive Disease Institute at Cleveland Clinic Abu Dhabi, “POP is an attractive option for patients who in the past would have been offered surgical therapy because it is less invasive. This endoscopic procedure results that are similar to the best alternatives, without the morbidity associated with surgical access, and has a short recovery time.” Dr. Rodriguez adds that “because of its safety profile, we are able to apply POP more broadly than we could apply surgical interventions.”

Dr. Rodriguez reports that Cleveland Clinic has taken the lead in the U.S. with the POP procedure, but because GI motility is so complex and gastroparesis fairly common, he expects to see the technique become more widespread as more experience aggregates on its long-term safety and effectiveness.