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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Joan B Gornals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 31, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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