Proximal intestinal mucosal ablation (PIMA) is safe and feasible as an endoscopic treatment for type 2 diabetes: the next evolution in metabolic endoscopy

Aims Radiofrequency Vapor Ablation (RFVA) is being investigated as a modality for duodenal mucosal ablation (DMA) in our first in-human sudy (NCT05887635). DMA is an endoscopic procedure for patients with type 2 diabetes (T2D) that destroys the abnormal hypertrophied duodenal mucosa to improve glycated haemoglobin (HbA1c). The aim is to emulate the glycaemic improvements observed following roux-en-Y gastric bypass whereby nutrients are diverted away from the biliopancreatic limb (BPL) of the proximal intestines. Given the typical length of the BPL is 50 cm, we hypothesised that extending the ablation to around this length could improve the metabolic effects of RFVA. Therefore, we developed a novel procedure called Proximal Intestinal Mucosal Ablation (PIMA). The aim of this study was to determine the safety, tolerability, and feasibility of PIMA using a new RFVA basket catheter.

Methods This was an extension to the single centre, prospective, pilot investigating RFVA as a modality of DMA to treat T2D. Using the new circumferential, through-the-scope, RFVA basket catheter, ablation length was extended to the proximal jejunum as part of the PIMA procedure. Patients with uncontrolled T2D (HbA1c 7.5-10.0%) despite≥1 antidiabetic drug underwent PIMA without lifestyle changes. PIMA was performed by double application of RFVA in the post-ampullary small intestines under general anaesthesia. Procedures were completed with a colonoscope (Olympus HQ190L) at 250J targeting≥20 cm but≤75 cm of ablated mucosa. Primary outcomes were safety (serious adverse events), tolerability (visual analogue score [VAS] for pain post-procedure), and feasibility (procedure time and ablation length). Exploratory outcomes assessed HbA1c reduction at 1-, 3-, and 6-months.

Results In total, seven patients underwent PIMA with an average age of 58 years (IQR 52-62) and 42.9% were female. The baseline HbA1c was 9.2% (SD 0.9), BMI was 31.5 kg/m2 (SD 2.5), and median number of antidiabetic drugs was 2 (IQR 1-2). The technical success was 100% with a median ablation length of 45 cm (IQR 26-53). The procedure time was 62 minutes (IQR 52-73) with an average speed of 1.5 minutes per/cm of ablation. Patients were admitted overnight and discharged the following day with no serious adverse events. The procedure was well-tolerated with an average VAS score of 1.8 (SD 2.7) on day 1 at worst. Five patients have reached one-month follow-up. All demonstrated a normal endoscopy at 28 days post-procedure. We observed a reduction in HbA1c by 1.1% (SD 0.8) without major change in weight (-1 kg; SD 2.5).

Conclusions PIMA is a safe and feasible treatment for T2D, which represents an evolution in metabolic endoscopy due the length of ablation possible with the new RFVA catheter.

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Artikel online veröffentlicht:
27. März 2025