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

September 3, 2022 updated by: Joan B Gornals

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

157

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona, Catalonia
      • Badalona, Barcelona, Catalonia, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol (Can Ruti)
      • L'Hospitalet de Llobregat, Barcelona, Catalonia, Spain, 08907
        • Hospital Universitari de Bellvitge
      • Terrassa, Barcelona, Catalonia, Spain, 08221
        • Hospital Universitari Mutua de Terrassa
    • Catalonia
      • Barcelona, Catalonia, Spain, 08041
        • Hospital de Sant Pau i de la Santa Creu
      • Girona, Catalonia, Spain, 17007
        • Hospital Universitari de Girona Doctor Josep Trueta
      • Lleida, Catalonia, Spain, 25198
        • Hospital Universitari Arnau de Vilanova de Lleida
      • Tarragona, Catalonia, Spain, 43005
        • Hospital Universitari Joan Xxiii de Tarragona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with subepithelial lesions (SEL) in the gastrointestinal tract.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joan B Gornals

Investigators

  • Principal Investigator: Francesc Bas-Cutrina, MD, Endoscopy Unit; Digestive Diseases Department; H. Universitari de Bellvitge.
  • Principal Investigator: Joan B Gornals, MD, PhD, Endoscopy Unit; Digestive Diseases Department; H. Universitari de Bellvitge.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2017

Primary Completion (Actual)

April 30, 2020

Study Completion (Actual)

March 30, 2021

Study Registration Dates

First Submitted

March 29, 2017

First Submitted That Met QC Criteria

August 8, 2017

First Posted (Actual)

August 11, 2017

Study Record Updates

Last Update Posted (Actual)

September 7, 2022

Last Update Submitted That Met QC Criteria

September 3, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BANDING-SET

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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