Duodenal mucosal resurfacing: proof-of-concept, procedural development, and initial implementation in the clinical setting
Open accessAbstract
Background and aims We aimed to develop duodenal mucosal resurfacing (DMR), a minimally invasive upper endoscopic hydrothermal ablation procedure, to treat insulin-resistant metabolic diseases.Methods We completed a sham-controlled, rodent proof-of-concept study and longitudinal safety study in pigs to demonstrate feasibility to test DMR in humans. Subsequently, the DMR procedure was implemented in an open-label first-in-human (FIH) study of safety and efficacy in patients with type 2 diabetes (T2D).Results In rats, duodenal abrasion reduced hyperglycemia by 59 mg/dL on average, compared with no change from baseline in the sham treatment arm (P < .05). In pigs, the balloon catheter successfully and safely delivered hydrothermal ablation to the duodenal mucosa and superficial submucosa. Complete mucosal healing was demonstrated by week 6. In the FIH study, hydrothermal ablation was successfully administered with no evidence of perforation, pancreatitis, or hemorrhage. Duodenal biopsy specimens obtained 3 months postprocedure demonstrated full mucosal regrowth. No inflammation was observed, and there was minimal-to-mild collagen banding deposition observed in a proportion of ablation site biopsy specimens with no evidence of fibrotic scarring. Glycemic and hepatic measures improved through 6 months of follow-up.Conclusions DMR shows potential as an endoscopic intervention that improves glycemic and hepatic parameters in patients with T2D. Further mechanistic and clinical studies are underway to further explore DMR as a treatment for metabolic disease.
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- Authors
- Haidry, R. J., van Baar, A. C., Galvao Neto, M. P., Rajagopalan, H., Caplan, J., Levin, P. S., Bergman, J. J., Rodriguez, L., Deviere, J., & Thompson, C. C.
- Affiliations
- University College Hospital (GB)
- Fractyl (United States) (US)
- Connecticut Science Center (US)
- Amsterdam UMC Location University of Amsterdam (NL)
- Erasmus Hospital (BE)
- Brigham and Women's Hospital (US)
- Corresponding author
- Thompson, Christopher C.
- Venue
- Gastrointestinal Endoscopy
- Publisher
- Elsevier BV
- Published
- 2019-10
- Volume
- 90
- Issue
- 4
- Pages
- 673-681.e2
- ISSN
- 0016-5107 (ISSN-L)
- OpenAlex
- W2931696747
- Cited by
- 66
- References
- 24
- Citations by year
- 2026: 5 · 2025: 10 · 2024: 9 · 2023: 8 · 2022: 8 · 2021: 11 · 2020: 10 · 2019: 5
- FWCI
- 6.90
- Type
- journal article
- Language
- en
- Open access
- green
- hdl.handle.net
- Licence
- Locations
- Gastrointestinal Endoscopy (publishedVersion)
- PubMed (publishedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Dépôt institutionnel de l'Université libre de Bruxelles (Université Libre de Bruxelles) (submittedVersion, other-oa)
- Pure Amsterdam UMC (submittedVersion)
- Funders
- Boston Scientific Corporation
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Surgery › Bariatric Surgery and Outcomes
- Health Sciences › Medicine › Surgery › Minimally Invasive Surgical Techniques
- Keywords
- duodenal mucosal resurfacing, type 2 diabetes, insulin resistance, duodenal mucosa, hyperglycemia, hepatic steatosis, porcine model, mucosal healing, collagen deposition
- MeSH terms
- Proof of Concept Study, Alanine Transaminase, Animals, Aspartate Aminotransferases, Blood Glucose, Constriction, Pathologic, Diabetes Mellitus, Type 2, Disease Models, Animal, Duodenoscopy, Duodenum, Glycated Hemoglobin, Humans, Intestinal Mucosa, Pancreatitis, Postoperative Complications, Swine, Postoperative Hemorrhage, Sus scrofa, Rats, Ablation Techniques, Non-alcoholic Fatty Liver Disease
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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