4 Efficacy

Guidance

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.

4.1 A non‑randomised study of 58 patients who had flexible endoscopic treatment or endoscopic stapling using a rigid endoscope reported mean dysphagia scores (measured on a scale of 0 to 3, with lower values meaning less severe symptoms) of 1.6 and 1.2 respectively after treatment compared with 2.8 and 2.7 respectively before treatment. Improvements in both groups were stated as being statistically significant but p values were not reported. A case series of 150 patients reported that the mean dysphagia score (measured on a scale of 0 to 4, with lower values meaning less severe symptoms) dropped from 1.9 at baseline to 0.3 at 1‑month follow‑up (p<0.01). This improvement was maintained in 134 patients with longer‑term follow‑up (median follow‑up was 43 months). In 5% (8/150) of patients there was no improvement in their symptoms at the time of discharge from hospital.

4.2 A case series of 42 patients reported that 93% (39/42) of patients had no dysphagia after a mean follow‑up of 38 months. A case series of 31 patients reported that 61% (19/31) of patients were successfully treated by a single procedure, with a mean follow‑up of 24 months; the clinical success rate based on intention to treat was 84% (26/31). A case series of 22 patients treated by a single procedure reported initial symptomatic improvement in 100% (22/22) of patients. After a mean follow‑up of 13 months, 68% (15/22) of patients had complete or near‑complete symptom resolution and 14% (3/22) had moderate symptom improvement.

4.3 The non‑randomised study of 58 patients reported recurrence of dysphagia in 1 patient who had flexible endoscopic treatment (at 14 months) and in 2 patients treated by endoscopic stapling using a rigid endoscope (at 15 and 18 months respectively). Re‑treatment of the residual bridge with 1 or 2 sessions of endoscopic treatment provided successful relief of symptoms in all 3 patients. The case series of 150 patients reported symptom recurrence in 23% (31/134) of patients after a median follow‑up of 7 months (range 1–82). Of the 31 patients with recurrence, 23 patients had a second treatment and 5 patients had a third treatment. After re‑treatment, 1 patient remained symptomatic. The case series of 42 patients reported recurrent dysphagia in 7% (3/42) of patients during follow‑up; these occurred at 12, 22 and 60 months after initial treatment respectively. Re‑treatment improved dysphagia in all 3 patients. A case series of 41 patients reported symptomatic recurrence during follow‑up in 15% (5/34) of patients (at 8, 9, 13, 15 and 18 months respectively).

4.4 The specialist advisers described the key efficacy outcome as resolution or reduction of dysphagia.