To prospectively evaluate the efficacy of RFA combined with ER in case of focal lesions, for BE with HGD/EC in 13 European centers with expertise in BE neoplasia. Patients with BE≤12 cm and HGD/EC on 2 separate endoscopies were included. Visible lesions (<2cm length; <50% circumference) were removed with ER, residual EC was excluded on 2 mapping endoscopies post-ER. Subsequent RFA was scheduled

every 3 months until clearance of BE was Selleck HSP inhibitor achieved, with max 5 RFA sessions allowed. Escape treatment was permitted for residual BE after RFA (max 2 APC sessions for islands <5mm, ER for islands >5mm or suspicious lesions). Follow-up (FU) endoscopy was scheduled at 3+9 mo after

last treatment and annually thereafter, with 4Q/2cm biopsies from ERK inhibitor mw neosquamous epithelium and gastric cardia. Endpoints: complete eradication of neoplasia (CE-neo) and intestinal metaplasia (CE-IM); durability of CE-neo/CE-IM. To ensure uniformity and protocol compliance, investigators were trained at the coordinating site and a study monitor attended all treatments and first FU on-site. Central pathology review of all ER/biopsies was performed at the coordinating site. 132 patients (107M, mean 65yrs, median BE C3M6) underwent en-bloc (n=63) or piecemeal ER (n=56); or no-ER (n=13). Worst ER histology: EC (n=78), HGD (n=31), LGD (n=7), no dysplasia (n=3). Worst grade post-ER/pre-RFA: HGD (n=36), LGD (n=45), no dysplasia (n=51). 124 pts Amine dehydrogenase completed the treatment phase, 8 discontinued due to unrelated causes. After a median of 3 (IQR 3-4) treatments, including ER (n=14) or APC (n=14), per intention-to-treat analysis (counting drop-outs as failures) CE-neo was reached in 122/132 (92%) and CE-IM in 115/132 (87%) pts. In a per-protocol analysis (censoring for drop-outs) CE-neo/CE-IM

were achieved in 98% and 93%, respectively. Of 2 CE-neo failures, 1 was referred for surgery (T1bN0M0), 1 patient was treated endoscopically (off-protocol). Of 115 pts who reached CE-neo/CE-IM per-protocol, CE-neo was maintained in 112/115 (97%) pts during median 25 (IQR 18-34) mo FU since last treatment, with median 4 (2-5) FU endoscopies and 41 biopsies per patient. 3 pts with recurrent neoplasia (EC n=1; HGD n=2) were effectively re-treated by ER or APC. This is the largest prospective multicenter trial on RFA combined with ER for treatment of BE with HGD/EC. Our outcomes suggest that if performed by trained, expert endoscopists in carefully selected patients, this combined approach is highly effective, and appears durable in the majority (97%) of patients once complete eradication of neoplasia and IM is established. “
“Barrett’s esophagus (BE) is the pre-cursor lesion to esophageal adenocarcinoma (EAC).