Banding Without Resection in Small Subepithelial Tumours (BANDING-SET)

Joan B Gornals

Status: Terminated

Conditions: Gastrointestinal Subepithelial Tumors

Treatments: Device: Endoscopic band ligation without resection; Procedure: SINK

Study type: Observational

Funder types: Other

Identifiers

NCT03247231

BANDING-SET

Details and patient eligibility

About

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

Full 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.

Enrollment: 157 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.