Status:
SUSPENDED
Anxiety and Fear of Cancer Before and After Banding Without Resection in Small SET Management (QUALI-BANDING-SET)
Lead Sponsor:
Francesc Bas-Cutrina
Conditions:
Gastrointestinal Subepithelial Tumors
Eligibility:
All Genders
18-80 years
Brief Summary
To analyze the hypothetical improvement in anxiety degree, quality of life and fear of cancer in patients diagnosed with a small gastrointestinal subeptithelial tumor when opting for the removal of th...
Detailed Description
This "Quality of Life" study is directly related to the "BANDING-SET" study (NCT03247231), whose main aim is to analyze the effectiveness and safety of endoscopic band ligation without resection in th...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Age between 18 and 80 years.
- Patient able to sign and understand the Informed Consent.
- Patient with a previously corroborated diagnosis of a subepithelial tumor (SET) by previous endoscopic ultrasonography (EUS), or possible diagnosis of SET by finding a subepithelial lesion (SEL) in a conventional endoscopy performed that will require a EUS study.
- Acceptance by the patient as a candidate of the BANDING-SET study (NCT03247231) of assessment of the effectiveness and safety of band ligation without resection of subepithelial tumors of the digestive tract ≤15-mm, with the prior signing of the Informed Consent of this study.
- Patient that understand the concept of the study and will complete all the time frame until the study end
- EXCLUSION CRITERIA:
- No Informed Consent.
- No BANDING-SET study (NCT03247231) Informed Consent.
- Patients with functional diversity, unable to understand the nature and possible consequences of the study.
- Patients unable to maintain subsequent follow-up (lack of adherence).
- Patients with a life expectancy of less than 12 months.
Exclusion
Key Trial Info
Start Date :
November 22 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2022
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04316000
Start Date
November 22 2019
End Date
March 1 2022
Last Update
September 8 2021
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