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Gastrointestinal Subepithelial TumorsBANDING-SETNCT03247231

Banding Without Resection in Small Subepithelial Tumours

An observational study of Gastrointestinal Subepithelial Tumors, run by Joan B Gornals at 7 sites in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

To analyse the effectiveness and safety of endoscopic band ligation without resection in small gastrointestinal subepithelial tumours. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Gastrointestinal Subepithelial Tumors
What is being tested?
Endoscopic band ligation without resection and SINK
How many people
157 participants
Where
7 sitesSpain
Study dates
31 Mar 2017to 30 Mar 2021
How long will I take part?
1 Year
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Spain7 sites

  • Hospital Universitari Germans Trias i Pujol (Can Ruti)

    Badalona, Barcelona, Catalonia, 08916

  • Hospital de Sant Pau i de la Santa Creu

    Barcelona, Catalonia, 08041

  • Hospital Universitari de Girona Doctor Josep Trueta

    Girona, Catalonia, 17007

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, Catalonia, 08907

  • Hospital Universitari Arnau de Vilanova de Lleida

    Lleida, Catalonia, 25198

  • Hospital Universitari Joan XXIII de Tarragona

    Tarragona, Catalonia, 43005

  • Hospital Universitari Mútua de Terrassa

    Terrassa, Barcelona, Catalonia, 08221

Other trials in Spain

About this study

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

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

Read the 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.

Being tested
Endoscopic band ligation without resection, SINK
Keywords
Endoscopic ultrasound, Small gastrointestinal subepithelial tumours, Endoscopic band ligation without resection, Single-incision needle-knife biopsy, Pre-cancerous tumours, Multicenter observational cohort study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endoscopic band ligation without resectionDevice

    Also called Endoscopic ligation, Endoscopic band ligation without electrosurgery, Band ligation with a mucosectomy device without resection

    Endoscopic treatment of subepithelial tumors: autoamputation by endoscopic band ligation without resection.

  • SINKProcedure or surgery

    Also called Single-incision needle-knife, Single-incision needle-knife and use of a biopsy forceps device

    To obtain sample tissue biopsies after the endoscopic band ligation without resection, performing a single-incision with a needle-knife.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Removal of the subepithelial tumour (initial clinical success).

    Complete removal and disappearance of the subepithelial tumour at 4-6 weeks by endoscopic ultrasonography control.

    Measured: 4-6 weeks

Secondary outcomes (5)

  1. Removal of the subepithelial tumour (global clinical success).

    Complete removal and disappearance of the subepithelial tumour at 1 year by endoscopic ultrasonography control.

    Measured: 1 year

  2. Number of participants with treatment-related adverse events as assessed by American Society of Gastrointestinal Endoscopy (ASGE) guideline.

    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).

    Measured: 1 year

  3. Technical success.

    Correct application of elastic banding.

    Measured: First day

  4. SINK biopsy efectiveness.

    Positive definitve pathological result rate of single-incision needle-knife (SINK) biopsies permorfed in subeptihelial tumours ligated.

    Measured: 4-6 weeks

  5. Long-term recurrence.

    Recurrence of indeterminate or pre-malignant subepithelial tumours rate at 5 years by endoscopic ultrasonography control.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2017
  2. Study start31 Mar 2017
  3. Primary completion30 Apr 2020
  4. Study completion30 Mar 2021

Why it stopped: Due to SARS-CoV2 (Covid-19) pandemia

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
157 participants (actual)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT03247231
Sponsor's protocol ID
BANDING-SET
Acronym
BANDING-SET
Status last verified
Sep 2022
First submitted
29 Mar 2017
Last updated
7 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • Bas-Cutrina F, Consiglieri CF, Bosch-Schips J, Gornals JB. Endoscopic band ligation plus single-incision needle knife biopsy for small subepithelial deep-layer tumor: easy and effective. Endoscopy. 2019 Jul;51(7):E191-E192. doi: 10.1055/a-0875-3958. Epub 2019 Apr 12. No abstract available.

    PubMed 30978731

  • Standards of Practice Committee; Faulx AL, Kothari S, Acosta RD, Agrawal D, Bruining DH, Chandrasekhara V, Eloubeidi MA, Fanelli RD, Gurudu SR, Khashab MA, Lightdale JR, Muthusamy VR, Shaukat A, Qumseya BJ, Wang A, Wani SB, Yang J, DeWitt JM. The role of endoscopy in subepithelial lesions of the GI tract. Gastrointest Endosc. 2017 Jun;85(6):1117-1132. doi: 10.1016/j.gie.2017.02.022. Epub 2017 Apr 3. No abstract available.

    PubMed 28385194

  • ASGE Technology Committee; Hwang JH, Konda V, Abu Dayyeh BK, Chauhan SS, Enestvedt BK, Fujii-Lau LL, Komanduri S, Maple JT, Murad FM, Pannala R, Thosani NC, Banerjee S. Endoscopic mucosal resection. Gastrointest Endosc. 2015 Aug;82(2):215-26. doi: 10.1016/j.gie.2015.05.001. Epub 2015 Jun 12.

    PubMed 26077453

  • Song JH, Kim SG, Chung SJ, Kang HY, Yang SY, Kim YS. Risk of progression for incidental small subepithelial tumors in the upper gastrointestinal tract. Endoscopy. 2015 Aug;47(8):675-9. doi: 10.1055/s-0034-1391967. Epub 2015 May 11.

    PubMed 25961444

  • de la Serna-Higuera C, Perez-Miranda M, Diez-Redondo P, Gil-Simon P, Herranz T, Perez-Martin E, Ochoa C, Caro-Paton A. EUS-guided single-incision needle-knife biopsy: description and results of a new method for tissue sampling of subepithelial GI tumors (with video). Gastrointest Endosc. 2011 Sep;74(3):672-6. doi: 10.1016/j.gie.2011.05.042.

    PubMed 21872716

  • Binmoeller KF, Shah JN, Bhat YM, Kane SD. Suck-ligate-unroof-biopsy by using a detachable 20-mm loop for the diagnosis and therapy of small subepithelial tumors (with video). Gastrointest Endosc. 2014 May;79(5):750-5. doi: 10.1016/j.gie.2013.09.028. Epub 2013 Nov 12.

    PubMed 24238309

  • Ibanez-Sanz G, Gornals JB, Rivas L, Salord S, Paules MJ, Botargues JM, Galan M. Endoscopic band ligation without resection in selected patients for small and superficial upper gastrointestinal tract lesions. Rev Esp Enferm Dig. 2016 May;108(5):250-6. doi: 10.17235/reed.2016.4031/2015.

    PubMed 27022723

  • Bas-Cutrina F, Ballester-Clau R, Gonzalez-Huix F, Gornals JB. Gastric perforation during ligation-assisted endoscopic mucosal resection of a neuroendocrine tumor: banding without resection may be a safer option. Endoscopy. 2020 Oct;52(10):E370-E371. doi: 10.1055/a-1134-4742. Epub 2020 Mar 27. No abstract available.

    PubMed 32219785

  • Bas-Cutrina F, Loras C, Pardo A, Ballester-Clau R, Huertas C, Guarner-Argente C, Colan-Hernandez J, Consiglieri CF, Andujar X, Vilanova-Serra M, Gonzalez-Huix F, Pardo-Grau L, Maisterra S, Ruiz-Ramirez P, Garcia-Sumalla A, Tebe C, Videla S, Gornals JB. Management of small subepithelial tumors by endoscopic banding without resection and single-incision needle-knife-assisted biopsy sampling: a prospective multicenter study. Gastrointest Endosc. 2023 Dec;98(6):911-921.e8. doi: 10.1016/j.gie.2023.05.057. Epub 2023 May 30.

    PubMed 37263361

Questions about this trial

What is this clinical trial studying?

An observational study of Gastrointestinal Subepithelial Tumors, run by Joan B Gornals at 7 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Due to SARS-CoV2 (Covid-19) pandemia). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Removal of the subepithelial tumour (initial clinical success). (time frame: 4-6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03247231, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2022; AzTrials last refreshed its copy on 30 Oct 2026.

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