Abstract
Background
Endoscopic treatment of obesity might be an alternative to surgical treatment or,
preoperatively, serve as an auxiliary therapy to surgery in patients at increased
surgical risk.
Objective
To evaluate 6-month safety and efficacy of the Trans-Oral Endoscopic Restrictive Implant
System (TERIS) as weight-loss device.
Setting
University hospital.
Methods
Patients 18–50 years with a body mass index (BMI) of 40–50 kg/m2 or 35–40 kg/m2 with obesity-related co-morbidities were eligible. Included patients underwent an
endoscopic creation of a gastric pouch through attachment of a silicone restrictive
implant to 5 cardia plications. Main outcome measurements were safety, expressed as
serious adverse events and adverse events, and efficacy, expressed as percentage of
excess weight loss (EWL), weight loss (WL), and excess BMI loss (EBMIL).
Results
Eighteen patients (3 males) with BMI of 42.1 kg/m2 (interquartile range 40.3–46.9) were included. Three serious adverse events occurred
(2 pneumoperitoneum, 1 perforation). Adverse events subsided spontaneously or with
medication. In 62.5% of patients, the anchors remained intact for 6 months. Presented
as mean (±standard deviation), excess weight loss after 6 months was 30.1% (±9.8),
weight loss was 15.1% (±5.3), and excess BMI loss was 37.7% (±12.4). In those who
continued the study beyond the first 6 months, weight losses could only partially
be maintained due to the detachment of anchors and the unimpeded passage of food.
Conclusions
Three serious adverse events occurred in the first 7 patients. TERIS tolerability
results improved after major changes in the system and the operating procedure. TERIS
proved to be an effective 6-month treatment of obesity. As yet, because of the poor
durability of the system, it cannot be recommended as a standalone endoscopic bariatric
therapy. Therefore, the company decided to discontinue the TERIS system and to further
develop the successful parts of it, such as the articulating circular endoscopic stapler.
Keywords
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Article info
Publication history
Published online: March 01, 2016
Accepted:
February 23,
2016
Received:
February 21,
2016
Identification
Copyright
© 2016 American Society for Metabolic and Bariatric Surgery. Published by Elsevier Inc. All rights reserved.
