Gastrointestinal Subepithelial Tumors
Conditions
Keywords
Endoscopic ultrasound, Small gastrointestinal subepithelial tumours, Endoscopic band ligation without resection, Single-incision needle-knife biopsy, Pre-cancerous tumours, Multicenter observational cohort study
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.
Interventions
DEVICEEndoscopic band ligation without resection
Endoscopic treatment of subepithelial tumors: autoamputation by endoscopic band ligation without resection.
PROCEDURESINK
To obtain sample tissue biopsies after the endoscopic band ligation without resection, performing a single-incision with a needle-knife.
Sponsors
Joan B Gornals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| Technical success. | First day | Correct application of elastic banding. |
| SINK biopsy efectiveness. | 4-6 weeks | Positive definitve pathological result rate of single-incision needle-knife (SINK) biopsies permorfed in subeptihelial tumours ligated. |
| Long-term recurrence. | 5 years | Recurrence of indeterminate or pre-malignant subepithelial tumours rate at 5 years by endoscopic ultrasonography control. |
Countries
Spain
Outcome results
None listed