Hybrid Argon Plasma Coagulation (Hybrid-APC) for the treatment of Barrett*s esophagus with Low-Grade, High-Grade Intraepithelial Neoplasia or after Endoscopic Resection for Early Neoplasia

Hybrid Argon Plasma Coagulation (Hybrid-APC) for the treatment of Barrett*s esophagus with Low-Grade, High-Grade Intraepithelial Neoplasia or after Endoscopic Resection for Early Neoplasia - Prospective Multicenter study Hybrid-APC Barrett's esophagus neoplasia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40133

Enrollment

Registered

2014-05-05

Start date

2014-04-09

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barrett dysplasia precancerous

Interventions

Eradication of barrett's esophagus

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: a) Patients in the age of 18-85 years b) Residual BE (defined as columnar lined esophagus with intestinal metaplasia) after prior ER (max 3 ER procedures) for HGD or mucosal cancer, irrespective if the residual BE harbors NDBE, LGD or HGD, OR patients with a BE without prior ER and a confirmed histological diagnosis of HGD or LGD. c) Written informed consent.

Exclusion criteria

Exclusion criteria: a) BE with a C-value 10 cm b) Prior ER for G3/G4; L1; V1; R1 (vertical margin only) or submucosal invasion; c) Presence of endoscopically visible abnormalities at the time of initial APC treatment (additional ER is allowed); d) Presence of cancer in random biopsies obtained at the mapping endoscopy, 8-12 weeks before initial APC treatment; e) Pregnancy f) Patients in whom complete eradication is not considered a relevant treatment goal or in whom additional treatment is contraindicated; g) Patients in whom >80% of the BE has been resected by ER; h) Patients with incomplete wound healing 3 months post-ER despite adequate PPI-medication; i) Prior ablative therapy in the esophagus; j) Significant esophageal stenosis prior to initial APC treatment defined as a stenosis that can not be passed by a therapeutic endoscope or a stenosis that has been dilated endoscopically before. k) Presence of esophageal varices l) Anticoagulant therapy (apart from aspirin or NSAIDS) that can not be continued prior to APC or hemostatic disorders m) Life expectancy less than 1 year

Design outcomes

Primary

Measure	Time frame
1. Complete eradication of BE 2. Complete eradication of neoplasia	—

Secondary

Measure	Time frame
1. Number of Hybrid-APC treatment sessions (resection not considered) 2. Early and late postoperative complications (retrosternal pain, dysphagy, odynophagy, fever bleedings, perforation, stenosis, mortality) and required therapies for the treatment of stenosis (rate of bougie applications, number of dilatations applied to each patient) 3. Recurrence rate of BE and neoplasia within one year follow-up in both groups 4. Predictive factors for treatment success 5. Neoplastic progression under treatment	—

Measure

Time frame

1. Number of Hybrid-APC treatment sessions (resection not considered) 2. Early and late postoperative complications (retrosternal pain, dysphagy, odynophagy, fever bleedings, perforation, stenosis, mortality) and required therapies for the treatment of stenosis (rate of bougie applications, number of dilatations applied to each patient) 3. Recurrence rate of BE and neoplasia within one year follow-up in both groups 4. Predictive factors for treatment success 5. Neoplastic progression under treatment

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)