20 research outputs found
Gastric per-oral endoscopic myotomy (G-POEM) for refractory gastroparesis: results from an international prospective trial
OBJECTIVE: Although gastric per-oral endoscopic myotomy (G-POEM) is considered a promising technique for the management of refractory gastroparesis, high-quality evidence is limited. We prospectively investigated the efficacy and safety of G-POEM in unselected patients with refractory gastroparesis.
DESIGN: In five tertiary centres, patients with symptomatic gastroparesis refractory to standard medical therapy and confirmed by impaired gastric emptying were included. The primary endpoint was clinical success, defined as at least one score decrease in Gastroparesis Cardinal Symptom Index (GCSI) with ≥25% decrease in two subscales, at 12 months. GCSI Score and subscales, adverse events (AEs) and 36-Item Short Form questionnaire of quality of life were evaluated at baseline and 1, 3, 6 and 12 months after G-POEM. Gastric emptying study was performed before and 3 months after the procedure.
RESULTS: Of 80 enrolled patients, 75 patients (94%) completed 12-month follow-up. Clinical success at 12 months was 56% (95% CI, 44.8 to 66.7). GCSI Score (including subscales) improved moderately after G-POEM (p\u3c0.05). In a regression model, a baseline GCSI Score \u3e2.6 (OR=3.23, p=0.04) and baseline gastric retention \u3e20% at 4 hours (OR=3.65, p=0.03) were independent predictors of clinical success at 12 months, as was early response to G-POEM at 1 month after therapy (OR 8.75, p\u3c0.001). Mild procedure-related AEs occurred in 5 (6%) patients.
CONCLUSION: G-POEM is a safe procedure, but showed only modest overall effectiveness in the treatment of refractory gastroparesis. Further studies are required to identify the best candidates for G-POEM; unselective use of this procedure should be discouraged.
TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry NCT02732821
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Durability of Cryoballoon Ablation in Neoplastic Barrett's Esophagus
Endoscopic ablation can eradicate neoplastic Barrett's esophagus (BE) without visible lesions. Cryoballoon ablation (CBA) is an established but relatively newer ablative technique that can eliminate BE but data on the durability of its treatment effects are lacking. We assessed the durability of CBA treatment for neoplastic BE.
We performed a single-center cohort study of consecutive BE patients with confirmed low-grade dysplasia, high-grade dysplasia or intramucosal cancer treated with CBA to eradicate all BE. We excluded patients with prior ablative therapy. Visible lesions were removed with endoscopic mucosal resection prior to CBA. Outcomes included complete eradication of dysplasia (CE-D) and complete eradication of intestinal metaplasia (CE-IM) at 1 year, durability at 2 and 3 years after initial ablation, cumulative recurrence rate of dysplasia and IM, and rate of neoplastic progression.
Fifty-nine patients (55.9% with high-grade dysplasia; 20.3% with prior endoscopic mucosal resection) were tracked for a median of 54.3 months. CE-D and CE-IM at 1 year were 94.6% (53/56) and 75% (42/56), respectively. Allowing for retreatment, rates of maintained CE-D and CE-IM for those who have achieved CE-D or CE-IM were 100% (53/53) and 98% (47/48) at 2 years; 100% (45/45) and 98% (40/41), at 3 years, respectively. Cumulative recurrence rate was 1.9% (1/53) for dysplasia and 14.6% (7/48) for IM (not allowing for retreatment). There was no neoplastic progression.
In treatment-naïve patients with dysplastic BE, CBA is a durable endoscopic eradication therapy but endoscopic surveillance after eradication is still warranted