Page 90 - Read Online

Page 4 of 13 Castro et al. Mini-invasive Surg 2020;4:47 I http://dx.doi.org/10.20517/2574-1225.2020.14

en-Y gastric bypass (RYGB) [14,18] . The most studied of these devices is the duodeno-jejunal bypass sleeve
known as the Endobarrier (GI Dynamics, Boston, MA) which is removed endoscopically 12 months after
[19]
placement . Several trials have demonstrated the potential benefit of the Endobarrier for weight loss and
improved glucose control. A pilot study comprised 12 patients, reported a mean %EWL of 23.6% in 12 weeks
and only two patients required removal of the Endobarrier due to inappropriate device placement. Of
the 12 patients included, four were diabetic and did not require their diabetes medications during the
[20]
time the device was placed . A prospective trial of 42 subjects reported that the device was successfully
implanted in 39 patients and they were followed up for 1 year. They reported a 19.9% ± 1.8% reduction of
[21]
total body weight loss and the EWL was 47.0% ± 4.4% . Although some studies have reported positive
outcomes with this device, others have reported various adverse effects [7,14] . The ValenTx (ValenTx, Inc.
Carpinteria, CA, USA) is a gastro-duodenal bypass liner that is still being studied and little data exists
regarding long-term outcomes. A study involving 12 patients who had the ValenTx device placed for 1 year
demonstrated a mean percentage EWL of 54% but only 6 of the patients had a fully attached and functional
device . Further studies and improvement of the device are still needed for the device to be approved and
[22]
considered as an option for obesity.

Transpyloric shuttle
The Transpyloric Shuttle (TPS) (BARONova Inc, San Carlos, CA) is a large spherical bulb attached to a
smaller cylindrical bulb through a catheter that results in delayed gastric emptying and is FDA approved.
It is delivered transorally in the stomach and once it has been deployed, gastric and intestinal contractions
pull the TPS into the duodenum which stops at the pylorus, causing intermittent gastric outlet obstruction
and thus, delaying gastric emptying. Few studies have evaluated its safety and effectiveness. A single-
2
center prospective, non-randomized trial of 20 patients with a mean BMI of 36.0 kg/m reported a mean
EWL of 31.3% ± 15.7% at 3 months and a mean EWL of 50.0% ± 26.4% at 6 months. The device had to be
[23]
removed in two cases due to persistent gastric ulceration . A multicenter randomized sham-controlled
trial in the US evaluated the safety and effectiveness of the TPS for weight loss. All patients (n = 203) who
were treated with TPS reported an adverse event and 10/203 patients presented with a serious adverse
event, no mortality was reported . These results have not yet been published but the preliminary results
[24]
demonstrate that there is still a need for improvement so that it can be safely used in obese patients.

Magnetic compression gastrojejunostomy
[25]
Magnetic surgery for gastrointestinal surgery is an appealing approach that offers promising results .
The Incisionless Magnetic Anastomosis System (GI Windows, Boston, MA) creates an intestinal bypass
through compression of self-assembling magnets delivered endoscopically. The magnets are deployed in the
proximal jejunum and in the ileum with the use of pediatric colonoscopes under fluoroscopic visualization.
Once the magnets are deployed, they will couple and cause necrosis in the tissue, which leads to the
formation of an anastomosis and a dual pathway. The magnets will be expelled naturally after a couple of
days. Ryou et al. evaluated the feasibility of this device on eight pigs. By day 10, the anastomosis had
[26]
already been formed and by day 90, the magnets had been completely expelled with full anastomotic
patency. The first human pilot study included ten patients and used laparoscopy to confirm adequate
magnet coupling. The anastomosis was created in all subjects and no device-related serious adverse events
were reported. Patency of the anastomosis was confirmed at 2, 6, and 12 months. The mean total weight
loss was 14.6% and the mean excess weight loss was 40.2% at 12 months. This study also showed a decrease
[27]
in Hemoglobin A and fasting glucose in diabetic patients . Even though these results sound promising,
1C
further studies and longer-term results are needed to confirm the utility of the incisionless anastomotic
system.

Mucosal resurfacing for diabetes
Duodenal mucosal resurfacing (DMR) is a procedure that consists of hydrothermal ablation of the
duodenal mucosa. Once the catheter is advanced into the duodenum, a balloon is inflated with heated