Banding Without Resection in Small Subepithelial Tumours

Terminated

• Conditions: Gastrointestinal Subepithelial Tumors

• Registration Number: NCT03247231
• Lead Sponsor: Joan B Gornals

Brief Summary

To analyse the effectiveness and safety of endoscopic band ligation without resection in small gastrointestinal subepithelial tumours.

Detailed Description

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 Timeline

• Study First Submitted: 2017-03-29
• Study Start: 2017-03-31
• Study First Submitted QC: 2017-08-08
• Study First Posted: 2017-08-11
• Primary Completion: 2020-04-30
• Study Completion: 2021-03-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-03
• Last Update Posted: 2022-09-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 157

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Removal of the subepithelial tumour (initial clinical success).	4-6 weeks	Complete removal and disappearance of the subepithelial tumour at 4-6 weeks by endoscopic ultrasonography control.

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by American Society of Gastrointestinal Endoscopy (ASGE) guideline.	1 year	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).
SINK biopsy efectiveness.	4-6 weeks	Positive definitve pathological result rate of single-incision needle-knife (SINK) biopsies permorfed in subeptihelial tumours ligated.
Removal of the subepithelial tumour (global clinical success).	1 year	Complete removal and disappearance of the subepithelial tumour at 1 year by endoscopic ultrasonography control.
Technical success.	First day	Correct application of elastic banding.
Long-term recurrence.	5 years	Recurrence of indeterminate or pre-malignant subepithelial tumours rate at 5 years by endoscopic ultrasonography control.

Trial Locations

Locations (7)

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; 🇪🇸 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