“Transoral gastroplasty is feasible and apparently safe,” reported Jacques Deviere, MD, Department of Gastroenterology and Hepatopancreatology, Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium. Presenting these results during the 2008 Digestive Disease Week, Dr. Deviere reported that the second pilot study, which employed an approach modified from the first, has been sufficiently promising that a randomized study with a sham control has been recently launched. Participating centers are in the United States and Europe.
The transoral approach is based on a patented system called TOGA (Satiety Inc.), which employs transoral endoscopically guided staplers to create a stapled restrictive pouch along the lesser curve of the stomach. In the first pilot study with 21 patients, published earlier this year (Surg Endosc 2008;22:589-598), the device showed promise, producing a 24.4% excess weight loss at six months, but gaps in the staple line were observed in 13 (62%) of the patients. The device was modified before this second pilot study was conducted. The modifications were made in the stapler to improve precision and in the vacuum ports that are used to maneuver the gastric tissue.
In this more recent pilot study, 29 patients were treated at centers in Brussels and Mexico City. In the current protocol, the procedure is performed under general anesthesia. The stapling device is introduced along a guidewire and an endoscope is introduced through the device by a second operator for visualization. Tissue is sucked into vacuum ports to produce serosa-to-serosa and mucosa-to-mucosa apposition and is then stapled with a triple line of staples to create a pouch. The pouch restricts food volume for early satiety and has a narrowed outlet to slow emptying. In the second pilot study, the average procedure time was 94 minutes.
The procedure result was likened to a vertical band gastroplasty, but the major advantage over previous surgical procedures for obesity is the ability to avoid incisions in the abdominal wall, which is considered the source of many of the complications of bariatric surgery, including a slow recovery time.
“There were two serious adverse events in this series. The first was a case of respiratory insufficiency in a very obese patient who required prolonged intubation. The patient was fully recovered by the following day. The other was a case of acute gallstone pancreatitis seven months after the procedure,” Dr. Deviere said. He noted that staple line gaps were observed in 11 patients in this series, which is a large proportional reduction relative to the first pilot series. Most gaps were small and thought to be nonfunctional.
As part of the protocol, additional gastric restrictions were permitted after three months. This was performed in seven patients who were not considered to have achieved sufficient weight loss. Sedation rather than general anesthesia may be used for these procedures.
The most commonly reported side effects were pain, gastric ulcer, asthenia, diarrhea and nausea, but most resolved over time. Indeed, quality-of-life (QOL) measures produced “dramatic improvements” whether based on obesity-related QOL or general QOL, according to Dr. Deviere. Although he conceded that far longer follow-up is needed to assess the ability of this approach to provide sustained weight loss, the results have been sufficiently encouraging to prompt the randomized trial now under way.
Others have not overlooked the potential advantages of a transoral approach to obesity surgery. Another endoscopic device for full-thickness gastroplasty, which may be appropriate for surgical treatment of gastroesophageal reflux disease (GERD) as well as obesity, has also demonstrated promise in experimental models of disease. Although at an earlier stage of development, this device, which is also patented (SafeStich Medical Inc.), has an integrated excision and suture apparatus and also uses vacuum ports to maneuver the gastric wall.
This device, developed by Charles J. Filipi, MD, professor of surgery at Creighton University School of Medicine, Omaha, Neb., produces a pouch with a full-thickness muscularis propria-to-muscularis propria apposition.
“The preclinical work has demonstrated the feasibility of this device,” confirmed Rudolf J. Stadlhuber, MD, who presented the results on behalf of a team of researchers working at Creighton University. In animals, the procedure has been conducted with conscious sedation. Based on results so far, Dr. Stadlhuber predicted that clinical trials will begin next year.
Responding to Dr. Deviere’s comparison of this transoral approach to vertical band gastroplasty, a procedure that has been largely abandoned because of lack of long-term benefit, Eric Hungness, MD, a bariatric surgeon and assistant professor of surgery at Northwestern University Feinberg School of Medicine, Chicago, suggested that it might be appropriate to remain circumspect until longer follow-up is performed. He indicated that despite the obvious advantages to a transoral route, there are now many bariatric procedures discarded because of lack of sustained weight loss.
Acknowledging the gap often observed between short- and long-term benefits, Dr. Deviere agreed that the feasibility of a transoral route does not prove efficacy. He also acknowledged the need for larger numbers of patients evaluated in a controlled trial. However, he also suggested that easier surgical procedures are needed for the massive public health threat posed by obesity.
According to Dr. Deviere, “surgery is the major player in the treatment of obesity” outside of lifestyle changes, making easier, less risky, and less costly procedures a priority as the obesity epidemic expands.
Source: General Surgery News