Endoscopic resection (ER) and radiofrequency ablation (RFA) are effective treatment modalities for high-grade dysplasia (HGD) and early cancer (EC) in Barrett’s esophagus (BE). ER is, however, a technically complicated procedure with a significant risk of complications. The most frequent late complication is the occurrence of esophageal stenosis, especially for cases that require widespread resection. RFA effectively removes BE mucosa but has only been used for flat type mucosa without visibl
Conditions
Interventions
Endoscopic treatment with RFA and ER in a single endoscopic session in patients with a BE containing visible abnormalities with HGD or EC upon biopsy.
All patients will undergo a circumferential RF a
Sponsors
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Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 85 years inclusive; 2. BE with a minimal circumferential extent of 2 cm; 3. An endoscopically visible abnormality of type 0-I, 0-IIa, 0-IIc or a combination thereof, irrespective of its size; 4. A biopsy proven histological diagnosis of HGD and/or EC on two separate endoscopic sampling procedures; 5. HGD, G1 or G2 cancer in the endoscopic resection specimens, without involvement of the deeper resection margins, no lymphatic invasion, and a maximum infiltration depth into the submucosa <500µm; 6. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Any prior endoscopic treatment for esophageal adenocarcinoma of BE associated neoplasia; 2. Signs of local or distant metastasis on EUS (EUS is obligatory); 3. Signs of distant metastasis on CT-scan of thorax and/or abdomen (optional for mucosal lesions); 4. Any of the following findings in any of the ER specimens: A. G3 or G4 tumor differentiation; B. Lymphatic invasion; C. Infiltration into the submucosa >500µm; D. A positive deeper resection margin. 5. Endoscopic signs of esophageal varices; 6. Esophageal stenosis not allowing passage of a therapeutic endoscope with an ER-cap; 7. Prior esophageal surgery (except fundoplication).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The percentage of BE regression at 3 months follow-up after the combined ER and RFA procedure; 2. The rate of acute (i.e. < 3 days) complications after therapeutic procedures; 3. The rate of late (such as esophageal stenosis) complications occurring during the treatment phase or during follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The rate of complete remission of HGD and EC in all biopsies obtained at 12 months follow-up; 2. The rate of complete remission of BE, defined as the endoscopic absence of columnar lined epithelium upon inspection with NBI and the absence of intestinal metaplasia in all biopsy specimens obtained at 12 months follow-up; 3. The number of endoscopic therapeutic procedures; 4. The frequency, severity, and duration of patient's symptoms after the first therapeutic session as assessed with standardised questionnaires and patient diaries; 5. Maximum depth of injury (a) complete epithelial ablation, (b) maximum depth of ablation assessed as epithelium, lamina propria, muscularis mucosa, submucosa ('ablation' defined as any sign of irreversible injury: coagulum, loss of cellular architecture, and loss of nuclei). | — |
Contacts
Public ContactJ.J.G.H.M. Bergman
Academic Medical Center Bldg. C2-210, Meibergdreef
Outcome results
None listed