To analyse the effectiveness and safety of endoscopic band ligation without resection in small gastrointestinal subepithelial tumours.
Multicenter prospective study analysing the effectiveness and safety of endoscopic band ligation without resection in small (≤15-mm) gastrointestinal subepithelial tumours. This endoscopic technique will be complemented with a SINK (single-incision needle-knife) biopsy for ensuring the pathological diagnosis of the treated subepithelial tumour.
Study Type
OBSERVATIONAL
Enrollment
157
Endoscopic treatment of subepithelial tumors: autoamputation by endoscopic band ligation without resection.
To obtain sample tissue biopsies after the endoscopic band ligation without resection, performing a single-incision with a needle-knife.
Hospital Universitari Germans Trias i Pujol (Can Ruti)
Badalona, Barcelona, Catalonia, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Catalonia, Spain
Hospital Universitari Mútua de Terrassa
Terrassa, Barcelona, Catalonia, Spain
Hospital de Sant Pau i de la Santa Creu
Removal of the subepithelial tumour (initial clinical success).
Complete removal and disappearance of the subepithelial tumour at 4-6 weeks by endoscopic ultrasonography control.
Time frame: 4-6 weeks
Removal of the subepithelial tumour (global clinical success).
Complete removal and disappearance of the subepithelial tumour at 1 year by endoscopic ultrasonography control.
Time frame: 1 year
Number of participants with treatment-related adverse events as assessed by American Society of Gastrointestinal Endoscopy (ASGE) guideline.
Incidence of treatment-emergent adverse events, graded by American Society of Gastrointestinal Endoscopy (ASGE) guideline (Ref: Cooton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 2010;71:446-54).
Time frame: 1 year
Technical success.
Correct application of elastic banding.
Time frame: First day
SINK biopsy efectiveness.
Positive definitve pathological result rate of single-incision needle-knife (SINK) biopsies permorfed in subeptihelial tumours ligated.
Time frame: 4-6 weeks
Long-term recurrence.
Recurrence of indeterminate or pre-malignant subepithelial tumours rate at 5 years by endoscopic ultrasonography control.
Time frame: 5 years
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Barcelona, Catalonia, Spain
Hospital Universitari de Girona Doctor Josep Trueta
Girona, Catalonia, Spain
Hospital Universitari Arnau de Vilanova de Lleida
Lleida, Catalonia, Spain
Hospital Universitari Joan XXIII de Tarragona
Tarragona, Catalonia, Spain