Status:
TERMINATED
Banding Without Resection in Small Subepithelial Tumours
Lead Sponsor:
Joan B Gornals
Conditions:
Gastrointestinal Subepithelial Tumors
Eligibility:
All Genders
18-80 years
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 31 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 30 2021
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT03247231
Start Date
March 31 2017
End Date
March 30 2021
Last Update
September 7 2022
Active Locations (7)
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1
Hospital Universitari Germans Trias i Pujol (Can Ruti)
Badalona, Barcelona, Catalonia, Spain, 08916
2
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Catalonia, Spain, 08907
3
Hospital Universitari Mútua de Terrassa
Terrassa, Barcelona, Catalonia, Spain, 08221
4
Hospital de Sant Pau i de la Santa Creu
Barcelona, Catalonia, Spain, 08041