Table 1.
Summary of the most relevant studies on the efficacy and safety of primary and revisional endoscopic therapies.
| Type of Study | Number of Patients | Comparator Group | Weight Loss Outcome | AEs Outcome | |||
|---|---|---|---|---|---|---|---|
| Primary endoscopic therapies | Space occupying devices | Orbera® | Meta-analysis [35] | 1638 (17 studies) | None | EWL 25.44 (95% CI, 21.47–29.4) at 1 year | 33.7% pain and nausea 1.4% migration 0.1% gastric perforation |
| Obalon® | Double-blind RCT with sham group [39] | 387 | Lifestyle therapy | TBWL 7.1 ± 5.3 vs. 3.6 ± 5.1 kg | 0.4% SAEs (one bleeding and one balloon deflation | ||
| Elipse™ | Prospective observational [41] | 112 | None | TBWL 7.9% at 1 year | 51% nausea and vomiting 0% SAEs [25] * |
||
| Spatz3® | RCT [44] | 288 | Lifestyle therapy | TBWL 15.0% vs. 3.3% 32 weeks at 32 wks (p < 0.0001) | Seven SAEs (7%). No deaths | ||
| Transpyloric Shuttle® | Observational [46] | 20 | None | EWL 41% at 6 months | 10% early removal for gastric ulceration | ||
| Endoscopic gastroplasties | ESG | Meta-analysis [53] | 1815 (8 studies on ESG) 2179 (7 studies on LSG) |
Laparoscopic sleeve gastrectomy | TBWL 17.1% vs. 30.5% (ESG vs. LSG) at 1 year | Overall AEs 2.9% (95% CI 1.8–4.4) vs. 11.8% (95% CI 8.4–16.4) | |
| POSE | Meta-analysis [52] | 465 (5 studies on POSE) and 1717 (8 studies on ESG) | ESG | EWL 44.9 ± 2.1% vs. 68.3 ± 3.8% (POSE vs. ESG) at 1 year | 4 SAEs for POSE (3 bleeding and 1 hepatic abscess) | ||
| Endoscopic malabsoptive procedures | DMR | RCT [66] | 108 | Sham procedure | HbA1c reduction from 8.5 ± 0.7% to 7.5 ± 0.8% | None | |
| EndoBarrier® | RCT [70] | 80 | Conventional medical therapy | TBWL 9.7% vs. 2.1% at 1 year | 19 (39%) SAEs (11 re-intervention) | ||
| Endo Bypass System | Prospective observational [74] | 13 | None | EWL was 35.9% at 1 year | None | ||
| IMAS | Prospective observational [75] | 10 | None | TBWL was 14.6%; EWL% 40.2% at 1 year | Diarrhea | ||
| Revisional Endoscopic therapies |
APC | RCT with sham group [81] | 42 | Diet | −9.73 kg vs. + 1.38 kg at 6 months | None in 1 year follow-up period | |
| Cryoablation | Retrospective series [79] | 22 | None | TBWL 8.1% at 8 weeks | 13.6% (one stenosis and 2 bleeding) | ||
| TORe | Meta-analysis [82] | 850 (13 studies) | None | TBWL 8.55% at 1 year | Total 11.4% ± 10.11 Severe 0.57% ± 1.35 |
||
| TORe + APC | Meta-analysis [83] | 1625 (16 studies) | TORe | TBWL at 12 months 9.5% vs. 5.8% | Strictures in 4.8% of patients | ||
| Sodium morrhuate | Prospective comparative [84] | 43 | TORe | TBWL 2.7% ±5.5 vs. 10.4% ± 2.2 | N/A | ||
| OTSC | Observational [85] | 94 | None | BMI drop from 32.8 (±1.9) to 27.4 (±3.8) at 1 year | Two stenoses requiring endoscopic dilation | ||
| R-Endosleeve | Prospective [88] | 82 | None | TBWL 15.7% (±7.6%) at 1 year | One moderate adverse event | ||
IGBs, intragastric balloons; ESG, endoscopic sleeve gastroplasty; POSE, primary obesity surgical endoluminal; APC, argon plasma coagulation; TORe, transoral outlet reduction endoscopically; OTSC, over-the-scope clip; LSG, laparoscopic sleeve gastrectomy; TBWL, total body weight loss; EWL, excess of weight loss; AEs, adverse events; SAEs, severe adverse events. * Data extracted from a meta-analysis on two studies with Elipse on 42 patients.