Banding Without Resection in Small Subepithelial Tumours

Study Overview
=================
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.

Official Title
-----------------
Effectiveness and Safety of the Endoscopic Band Ligation Without Resection of ≤15-mm Subepithelial Tumours of the Digestive Tract: a Multicenter Prospective Study

Conditions
-----------------
Gastrointestinal Subepithelial Tumors

Intervention / Treatment
-----------------
* Device: Endoscopic band ligation without resection
* Procedure: SINK


Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Age between 18 and 80 years old. Endoscopic ultrasound (EUS) image of a gastrointestinal subepithelial tumour (SET) ≤15-mm. Patient capable of understanding and signing informed consent form. Patient understanding the type of study and complying with the follow-up of complementary tests during the study duration. EXCLUSION CRITERIA: SETs >15-mm. SETs with clear diagnosis of EUS benign semiology: ie., lipoma, ectopic pancreas. Patients with multiple SETs (e.g., carcinoids). Vascular SETs (Doppler effect by EUS). Severe coagulation disorder: INR >1.5 not correctible with administration of plasma and/or platelets <50,000/mm3. Conditions that preclude upper digestive endoscopy, such as stenosis. Pregnancy or breast-feeding. Failure to sign informed consent form. Patients with functional diversity who are unable to understand the nature and possible consequences of the study, unless there is a competent legal representative. Patients unable to adhere to subsequent follow-up requirements. Patients with a life expectancy of less than 12 months.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Endoscopic band ligation without resection|Endoscopic treatment of subepithelial tumors: autoamputation by endoscopic band ligation without resection.|
|Procedure: SINK|To obtain sample tissue biopsies after the endoscopic band ligation without resection, performing a single-incision with a needle-knife.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Removal of the subepithelial tumour (initial clinical success). | Complete removal and disappearance of the subepithelial tumour at 4-6 weeks by endoscopic ultrasonography control. | 4-6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Removal of the subepithelial tumour (global clinical success). | Complete removal and disappearance of the subepithelial tumour at 1 year by endoscopic ultrasonography control. | 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). | 1 year | 
| Technical success. | Correct application of elastic banding. | First day | 
| SINK biopsy efectiveness. | Positive definitve pathological result rate of single-incision needle-knife (SINK) biopsies permorfed in subeptihelial tumours ligated. | 4-6 weeks | 
| Long-term recurrence. | Recurrence of indeterminate or pre-malignant subepithelial tumours rate at 5 years by endoscopic ultrasonography control. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endoscopic ultrasound, Small gastrointestinal subepithelial tumours, Endoscopic band ligation without resection, Single-incision needle-knife biopsy, Pre-cancerous tumours, Multicenter observational cohort study