Betsy Bates contributed to this report from Las Vegas.
BERLIN — A new device that makes transoral gastroplasty possible, thereby avoiding any incision, was safe and effective with 3 months of follow-up in a pilot study with 21 morbidly obese patients.
The transoral gastroplasty (TOGa) system uses an orally introduced endoscope to deliver vacuum and staples to create a pouch within the patient's stomach. The procedure uses “exactly the same technique as Mason's gastroplasty,” Dr. Jacques Devière said at the 14th United European Gastroenterology Week.
Three months after the procedure, the first 21 patients had lost a mean of about 20% of their excess weight with no severe or long-lasting complications, said Dr. Devière, chief of the division of gastroenterology at Erasme University, Brussels.
The study was sponsored by Satiety Inc., Palo Alto, Calif., which makes the device. A larger study aimed at collecting the data for Food and Drug Administration approval is expected to start next year.
The study enrolled 9 patients in Brussels and 12 at a hospital in Mexico City. All patients had a body mass index (BMI) of more than 35 kg/m2 plus at least one comorbidity, or a BMI of more than 40 kg/m2. The average BMI of the enrolled patients was 43 kg/m2 (range 35–53 kg/m2). The most common comorbidities were hypertension, in 48%, and diabetes, in 33%.
The procedure was done under general anesthesia. The TOGa device, 19 mm in diameter, was inserted through the patient's mouth and down the esophagus to the stomach under direct endoscopic control.
In the stomach, a vacuum pulls the anterior and posterior wall surface into position, with a septum placed between the walls to prevent cross-attachments. Two 4.5-cm staple lines are made with standard, titanium staples to create a restrictive sleeve along the lesser curve of the stomach. The stomach walls are positioned so that the staples produce a four-layer structure. After the sleeve is formed, vacuum is applied a second time and additional staples are placed at the distal end to narrow the outflow tract.
In 11 of 12 of the Mexico City patients, a concomitant laparoscopy was performed so that the procedure could be observed for potential complications, noted Dr. Steven Edmundowicz, chief of endoscopy at Washington University in St. Louis and one of the coauthors of the North American trial.
No serious adverse events occurred, Dr. Edmundowicz said at the annual meeting of the American College of Gastroenterology in Las Vegas. His report was delivered 2 days before Dr. Devière presented the combined study data in Berlin.
All patients were ready to be discharged after 24 hours, and all were discharged within 48 hours of their procedure, Dr. Devière said at the European meeting, sponsored by the United European Gastroenterology Federation. All complications were mild and all but one resolved within 5 days. These included five patients with pain, four with nausea, four with vomiting, three with dysphagia, and one with pharyngitis. One patient had mild temporomandibular dysfunction secondary to the procedure that lasted for 10 days. It's conceivable that the procedure could be done on an outpatient basis, Dr. Devière said.
One month following surgery, esophagogastroduodenoscopy (EGD) examinations revealed that 100% of the staple line persisted in 7 of 12 Mexico City patients. In the remaining patients, the staple line had separated by as much as half of its original length. “Think of a zipper that would open. It doesn't create quite the length of restriction that we provided,” Dr. Edmundowicz said.
The issue appears to be a technical one, requiring adjustment of the staple size to accommodate stomach wall thickness. “Our engineers believe they can actually overcome this challenge,” he said. “We need to focus on making that staple line much more durable.”
Ironically, the weight loss achieved in patients with a separated staple line did not differ statistically from that with a fully intact closure, so consideration also needs to be given to how long a staple line is actually needed, Dr. Edmundowicz added.
At their 3-month follow-up examination, all 21 patients had lost an average of about 12 kg, similar to what would be expected after conventional gastroplasty surgery, Dr. Devière said.
Besides the reduced hospital stay that's made possible by avoiding incisional bariatric surgery, the new procedure, once perfected, could potentially avoid complications associated with a bowel-to-bowel anastomosis, Dr. Edmundowicz noted at a press briefing during the Las Vegas meeting.
“We're really not hooking bowel to bowel, so we don't have to worry about leakage. We don't have to worry about breakdowns,” he said.