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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03247231
Recruitment Status : Recruiting
First Posted : August 11, 2017
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
JOAN B GORNALS, Hospital Universitari de Bellvitge

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

Condition or disease Intervention/treatment
Gastrointestinal Subepithelial Tumors Device: Endoscopic band ligation without resection Procedure: SINK

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 157 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Effectiveness and Safety of the Endoscopic Band Ligation Without Resection of ≤15-mm Subepithelial Tumours of the Digestive Tract: a Multicenter Prospective Study
Actual Study Start Date : April 21, 2016
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy


Intervention Details:
  • Device: Endoscopic band ligation without resection
    Endoscopic treatment of subepithelial tumors: autoamputation by endoscopic band ligation without resection.
    Other Names:
    • Endoscopic ligation
    • Endoscopic band ligation without electrosurgery
    • Band ligation with a mucosectomy device without resection
  • Procedure: SINK
    To obtain sample tissue biopsies after the endoscopic band ligation without resection, performing a single-incision with a needle-knife.
    Other Names:
    • Single-incision needle-knife
    • Single-incision needle-knife and use of a biopsy forceps device


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. Technical success. [ Time Frame: First day ]
    Correct application of elastic banding.

  4. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with subepithelial lesions in the gastrointestinal tract.
Criteria

INCLUSION CRITERIA:

  • Age between 18 and 80 years.
  • Endoscopic ultrasound 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's duration.

EXCLUSION CRITERIA:

  • Subepithelial tumours >15-mm.
  • Subepithelial tumors with clear diagnosis of EUS benign semiology: lipoma, ectopic pancreas.
  • Patients with multiple subepithelial tumours (eg, carcinoids).
  • Vascular subepithelial tumours (Doppler imaging observed by endoscopic ultrasound).
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03247231


Contacts
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Contact: Joan B Gornals, MD, PhD +34 93 260 76 82 ext 2624 jgornals@bellvitgehospital.cat
Contact: Francesc Bas-Cutrina, MD +34 93 260 76 82 ext 2624 francescb@bellvitgehospital.cat

Locations
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Spain
Hospital Universitari Germans Trias i Pujol (Can Ruti) Recruiting
Badalona, Barcelona, Catalonia, Spain, 08916
Contact: Juan A Colán, MD         
Hospital Universitari de Bellvitge Recruiting
L'Hospitalet de Llobregat, Barcelona, Catalonia, Spain, 08907
Contact: Joan B Gornals, MD, PhD    +34 93 260 76 82 ext 2624    jgornals@bellvitgehospital.cat   
Contact: Francesc Bas-Cutrina, MD    +34 93 260 76 82 ext 2624    francescb@bellvitgehospital.cat   
Sub-Investigator: Claudia F. Consiglieri, MD, PhD         
Sub-Investigator: Sandra Maisterra, MD         
Sub-Investigator: Albert Garcia-Sumalla, MD         
Sub-Investigator: Sergi Bazaga Pérez de Rozas, MD         
Hospital Universitari Mútua de Terrassa Recruiting
Terrassa, Barcelona, Catalonia, Spain, 08221
Contact: Carme Loras, MD, PhD         
Sub-Investigator: Xavi Andújar, MD         
Hospital de Sant Pau i de la Santa Creu Recruiting
Barcelona, Catalonia, Spain, 08041
Contact: Carles Guarner-Argente, MD, PhD         
Hospital Universitari de Girona Doctor Josep Trueta Recruiting
Girona, Catalonia, Spain, 17007
Contact: Carlos Huertas, MD, PhD         
Hospital Universitari Arnau de Vilanova de Lleida Recruiting
Lleida, Catalonia, Spain, 25198
Contact: Ferran González-Huix, MD, PhD         
Sub-Investigator: Raquel Ballester-Clau, MD         
Sub-Investigator: Natividad Zaragoza-Velasco, MD         
Sub-Investigator: Isabel Miguel, MD         
Hospital Universitari Joan XXIII de Tarragona Recruiting
Tarragona, Catalonia, Spain, 43005
Contact: Albert Pardo, MD, PhD         
Sponsors and Collaborators
JOAN B GORNALS
Investigators
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Principal Investigator: Joan B Gornals, MD, PhD Endoscopy Unit; Digestive Diseases Department; H. Universitari de Bellvitge.
Principal Investigator: Francesc Bas-Cutrina, MD Endoscopy Unit; Digestive Diseases Department; H. Universitari de Bellvitge.
Additional Information:

Publications:

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Responsible Party: JOAN B GORNALS, Principal investigator, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT03247231    
Other Study ID Numbers: BANDING-SET
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by JOAN B GORNALS, Hospital Universitari de Bellvitge:
Endoscopic ultrasound
Small gastrointestinal subepithelial tumours
Endoscopic band ligation without resection
Single-incision needle-knife biopsy
Pre-cancerous tumours
Multicenter observational cohorts study
Additional relevant MeSH terms:
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Neoplasms