Tessa Verlaan1, Koen de Jong2, Ellen D de la Mar-Ploem2, Elisabeth A Veldhuyzen3, Elisabeth M Mathus-Vliegen2, Paul Fockens2. 1. Department of Gastroenterology and Hepatology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands. Electronic address: t.verlaan@amc.uva.nl. 2. Department of Gastroenterology and Hepatology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands. 3. Department of Dietetics, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
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.
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.
Authors: Francesco Maria Carrano; Miroslav P Peev; John K Saunders; Marcovalerio Melis; Valeria Tognoni; Nicola Di Lorenzo Journal: Obes Surg Date: 2020-02 Impact factor: 4.129