After different studies on the main endoscopic techniques to treat obesity and participating in others, the bariatric endoscopy medical team at Centro Medico Teknon in Barcelona has been selected to perform a new pilot study in Spain. Its objective is to evaluate a new technique, known as gastric sleeve with plication (GESP), which will be used to obtain accreditation from the United States Food and Drug Administration (FDA).
The study was carried out at the Endoscopy and Digestive Functional Tests Unit of the Teknon Medical Center, directed by Dr. Jorge C. Espinós and Dr. Jesús Turró. Dr. Román Turró is the principal investigator of the study and Dr. Jesús Turró is the co-investigator. Barham Abu Dayeh, Mayo Clinic, Rochester, USA.
Dr. Román Turró explains that the main advantages of endoscopic plication over other techniques currently used to treat obesity is that it offers greater safety and durability, as well as the possibility of performing the procedure again in the future.
What does the new bariatric endoscopic technique for treating obesity consist of?
The new technique allows an intervention similar to the gastric sleeve with endoscopy. With this minimally invasive approach, a better recovery of the patient is achieved, in addition to reducing the complications that may appear during the operation.
The study was carried out with patients between 35 and 40 BMI (Body Mass Index). Dr. Román Turró explains that this is so because the results will be used in the FDA accreditation and these are the requirements demanded by the American agency. In addition, patients with a higher BMI are, a priori, candidates for bariatric surgery.
Thus, a total of 17 individuals with a BMI between 31.9 and 38.8 were selected for the study. Subsequently, the study was extended to 39 patients.
The study was based on analyzing the results of the application of transmural gastric plication to perform endoscopic sleeve, with a change in the direction of the sutures, which allows a greater shortening and tubulization of the stomach.
The main objectives of the study are:
- To assess safety levels
- To study weight loss with the new procedure.
- To analyze the increase in satiety
- To study the slowing down of gastric emptying.
- To analyze a greater specificity in the selection of patients, so as to allow much more personalized treatments based on their characteristics.
After the intervention, patients were followed up for 12 months to record safety values, changes in weight and measurements related to satiety levels and slowing of gastric emptying.
First positive conclusions of the new endoscopic technique for obesity
After the first months since the study began, the first conclusions on results are encouraging. Thus, of 39 operations performed, all have been successful and there have been no significant adverse effects. All the patients were discharged 24 hours after the operation.
Thus, the first 17 patients who underwent the technique showed an average weight loss of 11.17 kg after two months, which represents 34.26% of the patients’ excess weight.
Dr. Turró explains that greater homogeneity of the results is being observed and a greater weight loss is being achieved. However, he acknowledges that it is still too early to draw definitive conclusions, although the results are encouraging.