Guidance
4 Efficacy
This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.
Low‑grade dysplasia
4.1 A randomised controlled trial of 127 patients with non‑nodular dysplastic Barrett's oesophagus (64 with low‑grade dysplasia and 63 with high‑grade dysplasia) compared radiofrequency ablation plus endoscopic surveillance against endoscopic surveillance alone (sham procedure). Among patients with low‑grade dysplasia (n=64; 42 treated by radiofrequency ablation, 22 treated by sham procedure), complete eradication of dysplasia was reported in 91% (38/42) of patients treated by radiofrequency ablation, compared with 23% (5/22) treated by sham procedure at 12‑month follow‑up. Patients randomised to the sham procedure were offered crossover to radiofrequency ablation after 12 months. After crossover, complete eradication of all dysplasia and intestinal metaplasia was reported in 98% (51/52) of patients with low‑grade dysplasia at 2‑year follow‑up. At 3‑year follow‑up, dysplasia was eradicated in 100% (32/32) of patients.
4.2 A randomised controlled trial of 136 patients with low‑grade dysplasia comparing radiofrequency ablation (n=68) against endoscopic surveillance (control, n=68) reported that the low‑grade dysplasia treated by radiofrequency ablation was less likely to progress to adenocarcinoma (2% [1/68] compared with 9% [6/68], p=0.03) and less likely to progress to high‑grade dysplasia or adenocarcinoma (2% [1/68] compared with 27% [18/68], p<0.001) at 3‑year follow‑up. At the end of the treatment, complete eradication of dysplasia and intestinal metaplasia occurred in 93% (63/68) and 88% (60/68) of patients respectively in the radiofrequency ablation group (data not given for the control group). During follow‑up, complete eradication of dysplasia and metaplasia was maintained in 98% (62/63) and 90% (54/60) of patients respectively compared with 28% (19/68) (p<0.001) and 0% (p<0.001) of patients respectively in the control group.
4.3 The randomised controlled trial of 127 patients reported less progression from low‑grade dysplasia to high‑grade dysplasia in patients treated by radiofrequency ablation (5% [2/42]) compared with those treated by sham procedure (14% [3/22], p=0.33) at 12‑month follow‑up.
No dysplasia
4.4 A case series of 102 patients with non‑dysplastic Barrett's oesophagus (32 in a dosimetry phase I study and 70 in an effectiveness phase II study) reported complete eradication of intestinal metaplasia in 59% (19/32) of patients in the dosimetry phase and 69% (48/69) of patients in the effectiveness phase at 12‑month follow‑up. In the effectiveness phase study at 30‑month follow‑up, after additional focal ablation in patients with endoscopic and histological evidence of intestinal metaplasia at 12‑month biopsy, complete eradication of intestinal metaplasia was reported in 97% (60/61) of patients. At 5‑year follow‑up, complete eradication of intestinal metaplasia was reported in 92% (46/50) of patients, while 8% (4/50) of patients had intestinal metaplasia that was treated with 'single salvage focal ablation' 1 month after biopsy (complete eradication of intestinal metaplasia was reported at subsequent 2‑month biopsy).
4.5 The specialist advisers listed key efficacy outcomes as eradication of dysplasia, prevention of progression to cancer, eradication of intestinal metaplasia, eradication of Barrett's oesophagus and quality of life.