Aims
Minimally invasive endoscopic therapies have emerged as alternatives to bariatric surgery for patients with obesity. Among these, gastric fundus endoscopic ablation (GFEA) — a technique aimed at reducing gastric accommodation and decreasing ghrelin secretion — and the BioEnterics Intragastric Balloon (BIB) — which induces early satiety through intragastric volume displacement — represent two distinct approaches. Comparative evidence, however, are not available.
Methods
After reviewing the available literature on mechanisms, efficacy, and safety of GFEA and BIB in obesity treatment, including pilot trials, observational series, and meta-analyses of intragastric balloon (IGB) therapy, we designed a prospective randomized study on comparison between the two techniques. Primary outcomes was total body weight loss (TBWL); secondary outcomes were tolerability and rates of complications.
Results
10 obese patients (mean BMI ~40 kg/m²) were included and equally randomized in GFEA using hybrid argon-plasma ablation of the fundus and placement of air-inflated BIB. At 6 months, mean TBWL ranged from 8 to 10% in GFEA group and from 10 to 12% TBWL in ballon group (p>0,1).
No serious adverse events occurred in both groups. In GFEA group, intense postprocedural abdominal pain was experienced in one patient while in BIB group one patient needed early removal due to intolerance at day one .
No gastric ulceration or perforation were reported in both group.
Conclusions
Gastric fundus endoscopic ablation and the BioEnterics Intragastric Balloon are both effective and with low rate of adverse events. While BIB offers more established short-term outcomes, GFEA appears promising for more durable physiological modulation through reduction of ghrelin secretion and fundic capacity; however, evidence remains preliminary.