Aims:
The endoscopic-band-ligation (EBL) without resection combined with a single-incision-needle-knife (SINK) biopsy is a little reported option in the management of submucosal-tumours (SMT). The main aim was to determine the efficacy of this technique. Secondary aims: to evaluate its safety and the diagnostic yield of biopsy.
Methods:
Prospective multicenter study. Inclusion criteria: SMT≤15 mm, confirmed by endoscopic-ultrasound (EUS). Technical success: complete EBL of the SMT plus SINK biopsy. Clinical success: total disappearance of the SMT. Clinical controls: recovery at first 6-hours, calling at 48-hours and 7-days. EUS control at 4 – 6 weeks and 12 months. Clinical-Trials.gov register: NCT03247231.
Results:
Sixty-four cases (44% of the sample calculation); EUS-control 4 – 6 weeks n = 51. Esophagus n = 3, stomach n = 49, duodenum n = 11, rectum n = 1. SMT medium-size: 9.5-mm (4.5 – 15 mm). EBL technical success: 87.5% (n = 56/64). Clinical success at 4 – 6 weeks: 92.2% (n = 47/51), overall clinical success: 79.7% (n = 47/59). SMT dependence of superficial vs. deep layer subanalysis: technical success 93% vs. 75%; overall clinical success 87% vs. 65%. SMT≤10-mm vs. > 10-mm: technical success 100% vs. 68%; overall clinical success 97% vs. 54%. Pathological diagnosis: 62.5% (30/48); no differences between SMT-size, SMT-layer, or number or biopsies. Two mild adverse events (3%): bleeding, pain. Incidences: epigastralgy (6h: 33%; 24 – 48h: 30%; 7-days: 14%; 4 – 6 weeks: 2%).
Tab. 1:
Technical and clinical success subanalysis
|
Superficial layer
|
Deep layer
|
SMT ≤10-mm
|
SMT > 10-mm
|
YES technical success
|
41 (93%)
|
15 (75%)
|
39 (100%)
|
17 (68%)
|
NO technical success
|
3 (7%)
|
5 (25%)
|
0 (0%)
|
8 (32%)
|
YES clinical success
|
34 (94%)
|
13 (87%)
|
34 (97%)
|
13 (81%)
|
Overall NO clinical success
|
5 (13%)
|
7 (35%)
|
1 (3%)
|
11 (46%)
|
Conclusions:
Preliminary results in the short-medium follow-up term indicate that EBL of small SMT, supplemented with SINK biopsy, seems to be a feasible and safe technique. The limitations of its technical and clinical success seem to be associated with the SMT size and deep layers dependence.