Trans-oral Endoscopic Restrictive Implant System: endoscopic treatment of obesity?
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.


METHODS
University hospital.


METHODS
Patients 18-50 years with a body mass index (BMI) of 40-50 kg/m2or 35-40 kg/m2with 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.
Department of Gastroenterology and Hepatology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands. Electronic address: t.verlaan@amc.uva.nl.
Tessa
T
Verlaan
Department of Gastroenterology and Hepatology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Koen
K
de Jong
Department of Gastroenterology and Hepatology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Ellen D
ED
de la Mar-Ploem
Department of Dietetics, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Elisabeth A
EA
Veldhuyzen
Department of Gastroenterology and Hepatology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Elisabeth M
EM
Mathus-Vliegen
Department of Gastroenterology and Hepatology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Paul
P
Fockens
D000293:Adolescent; D000328:Adult; D020878:Device Removal; D016099:Endoscopy, Gastrointestinal / Q000295:instrumentation*; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000601:surgery*; D011183:Postoperative Complications / Q000209:etiology; D011446:Prospective Studies; D019736:Prostheses and Implants; D017792:Surgical Stapling; D016896:Treatment Outcome; D015431:Weight Loss / Q000502:physiology; D055815:Young Adult
Feasibility; Obesity; Safety; TERIS; Upper GI endoscopy; Weight loss