Complete ablation of esophageal epithelium with a balloon-based bipolar electrode: a phased evaluation in the porcine and in the human esophagus

Ganz, Robert A.; Utley, David S.; Stern, Roger A.; Jackson, Jerome; Batts, Kenneth P.; Termin, Paul

doi:10.1016/s0016-5107(04)02220-5

Cited by 163 publications

(117 citation statements)

References 10 publications

Supporting

Mentioning

107

Contrasting

Unclassified

Order By: Relevance

“…The procedure consists of duodenal sizing, saline expansion of the submucosal space, and hydrothermal treatment of the mucosa at denaturation temperatures to ablate superficial layers and trigger a rejuvenative healing response. The DMR procedure is analogous to the commonly performed radiofrequency ablation of the esophagus, where ablation and subsequent healing of esophageal mucosa is used to treat Barrett esophagus and esophageal dysplasia (34,35). DMR treatment targets the mucosal surface of the duodenum distal to the ampulla of Vater and proximal to the ligament of Treitz.…”

Section: Discussionmentioning

confidence: 99%

Endoscopic Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes: 6-Month Interim Analysis From the First-in-Human Proof-of-Concept Study

et al. 2016

View full text Add to dashboard Cite

OBJECTIVETo assess procedural safety and glycemic indices at 6 months in a first-in-human study of duodenal mucosal resurfacing (DMR), a novel, minimally invasive, upper endoscopic procedure involving hydrothermal ablation of the duodenal mucosa, in patients with type 2 diabetes and HbA 1c ‡7.5% (58 mmol/mol) on one or more oral antidiabetic agents. RESEARCH DESIGN AND METHODSUsing novel balloon catheters, DMR was conducted on varying lengths of duodenum in anesthetized patients at a single medical center. RESULTSA total of 39 patients with type 2 diabetes (screening HbA 1c 9.5% [80 mmol/mol]; BMI 31 kg/m 2 ) were treated and included in the interim efficacy analysis: 28 had a long duodenal segment ablated (LS; ∼9.3 cm treated) and 11 had a short segment ablated (SS; ∼3.4 cm treated). Overall, DMR was well tolerated with minimal gastrointestinal symptoms postprocedure. Three patients experienced duodenal stenosis treated successfully by balloon dilation. HbA 1c was reduced by 1.2% at 6 months in the full cohort (P < 0.001). More potent glycemic effects were observed among the LS cohort, who experienced a 2.5% reduction in mean HbA 1c at 3 months postprocedure vs. 1.2% in the SS group (P < 0.05) and a 1.4% reduction at 6 months vs. 0.7% in the SS group (P = 0.3). This occurred despite net medication reductions in the LS cohort between 0 and 6 months. Among LS patients with a screening HbA 1c of 7.5-10% (58-86 mmol/mol) and on stable antidiabetic medications postprocedure, HbA 1c was reduced by 1.8% at 6 months (P < 0.01). CONCLUSIONSSingle-procedure DMR elicits a clinically significant improvement in hyperglycemia in patients with type 2 diabetes in the short-term, with acceptable safety and tolerability. Long-term safety, efficacy, and durability and possible mechanisms of action require further investigation.

show abstract

Section: Discussionmentioning

confidence: 99%

Endoscopic Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes: 6-Month Interim Analysis From the First-in-Human Proof-of-Concept Study

et al. 2016

View full text Add to dashboard Cite

show abstract

“…This application of controlled thermal energy causes water vaporization, coagulation of proteins, and cell necrosis. 8 The desiccated tissue has much higher resistance to current than normal tissue. This leads to an ablation depth that is well controlled and provides a superficial depth of injury.…”

Section: Endoscopic Therapymentioning

confidence: 99%

Post-ablation lymphocytic esophagitis in Barrett esophagus with high grade dysplasia or intramucosal carcinoma

et al. 2016

View full text Add to dashboard Cite

In patients who have undergone ablation therapy for treatment of Barrett's esophagus with dysplasia, histologic features of eosinophilic esophagitis, but not lymphocytic esophagitis, have been described. We evaluated for histologic evidence of eosinophilic esophagitis and lymphocytic esophagitis and correlated with endoscopic findings in this population. A single-institution Barrett's esophagus registry was searched for patients who had received radiofrequency ablation, cryotherapy, or both for treatment of Barrett's esophagus with dysplasia. Clinical and endoscopic data were collected and biopsies were reviewed for inflammation and reactive changes at three time points: pre-intervention, first surveillance after ablation therapy, and most recent surveillance. Of the 173 patients initially identified, 102 met the inclusion criteria. Intraepithelial eosinophils were increased at first surveillance (60%, P = 0.096) and last surveillance (69%, P = 0.048) compared with pre-intervention (50%), although histologic evidence of post-ablation eosinophilic esophagitis was not significant. Prevalence of lymphocytic esophagitis was significantly higher at first surveillance (17%, P = 0.02) and at last surveillance (43%, Po 0.001), compared with pre-intervention (7%). Smoking, hyperlipidemia, and cryotherapy were identified as independent risk factors for developing histologic lymphocytic esophagitis. This is the first report that histologic evidence of lymphocytic esophagitis increased over time in patients undergoing ablation for Barrett's esophagus with dysplasia. Though the pathophysiology of lymphocytic esophagitis remains unknown, patients in our study with a history of smoking, hyperlipidemia, or cryotherapy were more likely to develop post-ablation lymphocytic esophagitis.

show abstract

“…Studies involving circumferential ablation were initially conducted in the porcine animal model and in humans prior to esophagectomy in order to determine dosing and technique parameters. [22][23][24] Subsequently, RFA has been proven safe and effective for the eradication of dysplasia and IM in a number of clinical trials involving patients without dysplasia, with LGD or HGD, and after ER of EC and visible lesions. [25][26][27] In addition, no buried Barrett glands have been found in over 4,000 neosquamous biopsies obtained during follow-up, [25][26][27] oncogenetic abnormalities as present in the pretreatment BE are absent in the regenerated neosquamous epithelium after RFA, 28 and the functional integrity of the esophagus is not affected by RFA.…”

Section: Introductionmentioning

confidence: 99%

Eradication of Barrett Esophagus with Early Neoplasia by Radiofrequency Ablation, with or without Endoscopic Resection

Pouw

Gondrie

Sondermeijer

et al. 2008

Journal of Gastrointestinal Surgery

113

View full text Add to dashboard Cite

Background Radiofrequency ablation is safe and effective for complete eradication of nondysplastic Barrett esophagus (BE). The aim was to report the combined results of two published and two ongoing studies on radiofrequency ablation of BE with early neoplasia, as presented at SSAT presidential plenary session DDW 2008. Methods Enrolled patients had BE ≤12 cm with early neoplasia. Visible lesions were endoscopically resected. A balloonbased catheter was used for circumferential ablation and an endoscope-based catheter for focal ablation. Ablation was repeated every 2 months until the entire Barrett epithelium was endoscopically and histologically eradicated. Results Forty-four patients were included (35 men, median age 68 years, median BE 7 cm). Thirty-one patients first underwent endoscopic resection [early cancer (n=16), high-grade dysplasia (n=12), low-grade dysplasia (n=3)]. Worst histology remaining after resection was high-grade (n=32), low-grade (n=10), or no (n=2) dysplasia. After ablation, complete histological eradication of all dysplasia and intestinal metaplasia was achieved in 43 patients (98%). Complications following ablation were mucosal laceration at resection site (n=3) and transient dysphagia (n=4). After 21 months of follow-up (interquartile range 10-27), no dysplasia had recurred. Conclusions Radiofrequency ablation, with or without prior endoscopic resection for visible abnormalities, is effective and safe in eradicating BE and associated neoplasia.

show abstract

Complete ablation of esophageal epithelium with a balloon-based bipolar electrode: a phased evaluation in the porcine and in the human esophagus

Cited by 163 publications

References 10 publications

Endoscopic Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes: 6-Month Interim Analysis From the First-in-Human Proof-of-Concept Study

Endoscopic Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes: 6-Month Interim Analysis From the First-in-Human Proof-of-Concept Study

Post-ablation lymphocytic esophagitis in Barrett esophagus with high grade dysplasia or intramucosal carcinoma

Eradication of Barrett Esophagus with Early Neoplasia by Radiofrequency Ablation, with or without Endoscopic Resection

Contact Info

Product

Resources

About