A restrictive procedure via the endoluminal route without the need for a laparoscopic or laparotomic approach has the potential to decrease complications and could become an alternative to other interventions
Jacques Devière, MD PhD, Chairman
Department of Gastroenterology, Hepatopancreatology and
Digestive Oncology Erasme Hospital, Université Libre de Bruxelles, Belgium, President, European Society of
Obesity is one of the major worldwide pandemics, particularly in western countries. It is estimated that more than 300 million people are obese in the world. Its incidence is vastly growing in many countries. In the USA, the percentage of obese patients – those having a body mass index (BMI) of 30 or more – reached 24% in 2005.2 It is associated with increased risk of hypertension, diabetes, hyperlipidemia, sleep apnoea, coronary heart disease, stroke, liver disease, cancer and death.
If diet, exercise and pharmacotherapy remain the first-line therapies, they are associated with a frequent relapse of obesity and an inexorable climb back to, or above, the pre-intervention body weight. Bariatric surgical treatments
are the only ones that have been proven to induce long-term weight loss and are usually considered for patients with a BMI above 40 or with a BMI above 35 along with obesity-related co-morbidities.
Bariatric procedures can be divided into restrictive (vertical gastroplasty, gastric banding, sleeve gastrectomy), malabsorptive (biliopancreatic version) or a combination of both – Roux-en-Y gastric bypass (RYGBP). These procedures remain, however, associated with significant complications, which can be severe, with a mortality rate of 0.1 to 2% according to the kind of procedure. Among these complications, those associated with the transabdominal access, namely parietal complications such as incisional hernia, wound infection, fistula or leak are frequent, and long-term complications may also occur with implanted material.
A restrictive procedure that could be done by the endoluminal route without the need for a laparoscopic or laparotomic approach has therefore the potential to decrease the complications and might represent a minimally invasive approach, which could become an alternative to currently available restrictive bariatric procedures.
Technique of transoral gastroplasty
The procedure is performed under general anesthesia, usually with transnasal endotracheal intubation. The team consists of two physicians, two GI assistants and 1 anaesthetist. The patients are positioned supine and an upper endoscopy is performed, leaving a guidewire into the antrum. A 20 mm bougie is introduced over this guidewire to dilate and test for any resistance prior to device introduction. The TOGA Sleeve Stapler (Figure 1a) consists of a stapler in which the jaws can be opened into the stomach, with a septum deployed with a retraction wire used to spread and orient the stomach tissue for capture (Figure 1c). Capture is performed using high-power suction, applied through vacuum pods located close to the staplers. This TOGA Sleeve Stapler is introduced gently over a guidewire, and a paediatric scope is introduced through a dedicated channel into the device. This scope is used to observe the procedure in retroflexion. Once the stapler body is positioned along the lesser curve of the stomach, the stapler jaws are opened and the septum deployed using the retraction wire (Figure 1a, c). Suction is then applied, and tissue from the anterior and posterior walls of the stomach is acquired in the two vacuum pods of the device. The stapler is then closed and fired, delivering three rows of titanium staples (Figure 1d). This creates a transmural staple line connecting the anterior and posterior stomach and beginning at the level of or 1 cm proximal to the Z-line. This staple line of 5 cm is performed a second time in order to create a sleeve of approximately 8–9 cm in length (Figure 1e). The distal sleeve outlet is then narrowed using the TOGA Restrictor, also a vacuum-based stapler that acquires and staples the tissue to form small cushions that serve as distal restrictions. Two to five distal restrictions are placed until the outlet is less than 15 mm
(Figure 1b, f).
This completes a procedure that forms a restrictive gastroplasty along the lesser curve with an anatomy similar to gastric pouches created by open or laparoscopic procedures.
Two pilot studies have been currently published using this technique and have shown that this procedure was feasible and safe.[4,5] No severe adverse event has been reported to date, and it was demonstrated as possible to create a vertical pouch with a distal endoluminal restriction. Interestingly, no implantation of foreign material is necessary for this distal restriction.
In the first 21 patients treated by this technique, the percentage of excess weight loss was 24.5% at 6 months4 and was reported recently in abstract form to be 35% at 12 months. A second phase of the pilot trial has been performed after improvement of the design of the device in order to avoid the occurrence of stomas at the level of the staple lines, particularly between the two staple lines. Using this improved instrument, the mean excess weight loss at 6 months has reached 46%5 with a mean BMI decreasing from 41.6 at baseline to 33.1 six months after the procedure. This was also associated with a dramatic improvement in the IWQOL-Lite survey, which measures the quality of life specifically in relation to obesity, as well as in SF-36 surveys, which measures overall quality of life.
Currently, approximately 70 patients have been treated worldwide, and a multicentric randomised sham-controlled trial has started in the USA and Europe. The currently available data show that weight loss is still increasing at 12 months, and longer follow-up is ongoing. One of the typical features of this procedure was the smooth postoperative course; almost all the patients, in the setting of a phase 1 clinical trial, have been discharged within 24 hours after admission. This suggests that, in routine practice, this procedure could be performed on an
The currently available trials on TOGA have shown that this bariatric procedure performed by the endoluminal route is feasible and apparently safe and results in weight loss that is similar to other bariatric procedures. If these results are
confirmed long term, transoral gastroplasty could become a technique of endoluminal restrictive surgery offered as first line to morbidly obese patients. Interestingly, three patients who had failed to maintain weight loss after this procedure underwent a RYGBP without complication or technical difficulties. Moving from a transabdominal to a transoral approach might reduce parietal complications, hospital stay and work loss and, if validated in multicentre trials and in the long term, this technique might become a less invasive option for patients who are unwilling or unable to tolerate the potential risk of traditional bariatric surgery for obesity.
1. Haslam DW, James WPT. Obesity. Lancet 2005;366:1197-209.
2. DeMaria EJ. Bariatric surgery for morbid obesity. N Engl J Med 2007;356:2176-83.
3. Colquitt J, Clegg A, Loveman E, et al. Surgery for morbid obesity. Cochrane Database Syst Rev 2005;4:CD003641.
4. Devière J, Ojeda Valdes G, Cuevas Herrera L, et al. Safety, feasibility and weight loss after transoral gastroplasty (TOGA): first human multicenter study. Surg Endosc 2008;22:589-98.
5. Moreno C, Closset J, Dugardeyn S, et al. Transoral gastroplasty is safe, feasible, and induces significant weight loss in morbidly obese patients: results of the second human pilot study. Endoscopy 2008;40:406-13.