Ultrasound-guided insertion of the Elipse® gastric balloon: technical details, learning curve, and perioperative outcome in 36 cases

Abstract

Aim: Our aim is to demonstrate the feasibility of real-time ultrasound-assisted insertion of the Elipse^® intragastric balloon for the treatment of overweight and obese patients.

Methods: A plastic gastric phantom filled with water was created to mimic the gastric lumen and to test the operator's ability to recognize the capsule containing the balloon inside. In the clinical phase, we tested the operator's ability to recognize the swallowed capsule and its progressive filling in the gastric lumen by means of ultrasound in 36 consecutive patients with a mean body mass index of 35 in an outpatient setting.

Results: The ultrasound hyperechoic signal of the capsule in the gastric lumen was visible early on and was confirmed after the injection of a few milliliters of saline solution in the capsule with a cyst-like shape. The insertion of the balloon was successful in all cases at the first attempt, and the complete filling was monitored in real-time without the need for fluoroscopy. Postprocedure symptoms were limited to the first 24-48 h and were controlled by symptomatic therapy; endoscopic removal of the balloon because of painful distal gastric migration was necessary in one case after 3 months.

Conclusion: After a learning curve, we were able to demonstrate the placement of the balloon capsule inside the fundus of the stomach under ultrasound guidance without fluoroscopy in all patients in an outpatient setting.

Keywords: Bedside; Elipse gastric-balloon; Ultrasound-guided insertion.

Fig. 1

Elipse^® Balloon (Allurion Technologies, Wellesley, MA, USA). Capsule and filled balloon as they will appear before and at the end of the procedure. The Elipse^® Balloon (Allurion Technologies, Wellesley, MA, USA) is administered by swallowing a capsule; it is self-emptying and naturally excreted and may be desirable for patients who wish to avoid endoscopy and/or anesthesia

Fig. 2

The ultrasound image of the capsule device as it appears in the gastric phantom. Ultrasound hyperechoic linear shape of the capsule (white arrow) with the balloon before the deployment in a plastic gastric phantom containing water

Fig. 3

Ultrasound image sequence of device insertion in the gastric lumen. (a) Oblique longitudinal scan of the median upper abdomen: the gastroesophageal junction (GEJ) posterior to the left lobe of the liver (LL). The black arrow shows the hyperechoic catheter layer inside the cardia. (b) Oblique longitudinal scan of the median upper abdomen: the hyperechoic linear shape of the capsule containing the balloon before deployment (white arrow). (c) Oblique lateral scan through the spleen (SP): the capsule in the gastric fundus as a hyperechoic image with posterior acoustic shadow (white arrow). )d) Late phase of the balloon deployment (B) in the gastric fundus (GF)

Fig. 4

The sequence of the Elipse^® Balloon inflation phase in the gastric lumen. (a) Hyperechoic capsule (white arrow). (b) Early phase of balloon deployment (B). (c) Intermediate balloon filling (B). (d) Complete filling of the balloon (B). GF gastric fundus filled with water, M anterior abdominal wall muscle, D diaphragm