Performance and safety of duodenal mucosal ablation in the management of type 2 diabetes: a systematic review and meta-analysis

Aims Type 2 diabetes (T2D) is one of the biggest health issues of the 21^st century and the number of people living with the condition is expected to rise to 1.31 billion by 2050. Despite an increase in the number of anti-diabetic therapies, many patients with T2D are unable to achieve or maintain adequate diabetic. Unfortunately, this has a significant impact on morbidity due to traditional vascular complication and more recent effects on liver disease, cancer, and dementia. Duodenal mucosal ablation (DMA) is a novel minimally invasive endoscopic therapy that aims to selectively, and reversibly, destroy the abnormal hypertrophied duodenal mucosa among patients with inadequately controlled T2D to improve glycated haemoglobin (HbA1c). This is the first systematic review and meta-analysis, where we evaluate DMA by summarising the pooled evidence across the three current technologies being evaluated in clinical practice.

Methods A search in Medline, Cochrane and Scopus databases was performed for studies assessing DMA up to June 2024. The primary outcome was therapeutic effect, defined as the mean HbA1c reduction within six months post-procedure. Secondary outcomes included mean weight loss and complication rate, and a sensitivity analysis was performed stratifying by DMA device. We performed meta-analyses using a random-effects model and the results were reported as percentages with 95% confidence interval (CI).

Results Eight studies (421 patients) were eligible for analysis. Evidence regarding thermal ablation (REVITA system, Fractyl Health; Radiofrequency vapor ablation (RFVA); Aqua Medical) and non-thermal ablation (Re-Cellularization via Electroporation Therapy (ReCET), Endogenex) was provided. The mean reduction of HbA1c within 6 months was -1.08% (95%CI: -1.22, -0.93; I²=88%, p<0.001). The mean weight loss at 6-months was 2.37kg (95%CI: 1.89, 2.86; I²=0%, p=0.92) and adverse events were described in 11%, with only six considered severe. When only considering the REVITA system, a similar HbA1c reduction was observed [-1.01 (95%CI: 1.14, -0.87)] without reduction of heterogeneity (I²=85%, p<0.001).

Conclusions Endoscopic DMA shows a consistent treatment effect among patients with inadequately controlled T2D across all ablation technologies with a moderate safety profile. Optimising procedural efficiency, ablation delivery, and patient selection will improve and standardise the treatment outcome.

Publication History

Article published online:
27 March 2025