Banding Without Resection in Small Subepithelial Tumours

NCT03247231 | Terminated FDA Device

• 1 other identifier: BANDING-SET
• Study Type: observational
• Target: 157
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Gastrointestinal Subepithelial Tumors

Keywords

Endoscopic ultrasound; Small gastrointestinal subepithelial tumours; Endoscopic band ligation without resection; Single-incision needle-knife biopsy; Pre-cancerous tumours; Multicenter observational cohort study

Outcome Measures

Primary Outcomes (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.

  4-6 weeks

Secondary Outcomes (5)

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

  1 year

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

  1 year

• Technical success.

  First day

• SINK biopsy efectiveness.

  4-6 weeks

• Long-term recurrence.

  5 years

Interventions

Endoscopic band ligation without resection DEVICE

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

Also known as: Endoscopic ligation, Endoscopic band ligation without electrosurgery, Band ligation with a mucosectomy device without resection

SINK PROCEDURE

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

Also known as: Single-incision needle-knife, Single-incision needle-knife and use of a biopsy forceps device

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Joan B Gornals: lead

Study Sites (7)

Hospital Universitari Germans Trias i Pujol (Can Ruti)

Badalona, Barcelona, Catalonia, 08916, Spain

Location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Catalonia, 08907, Spain

Location

Hospital Universitari Mútua de Terrassa

Terrassa, Barcelona, Catalonia, 08221, Spain

Location

Hospital de Sant Pau i de la Santa Creu

Barcelona, Catalonia, 08041, Spain

Location

Hospital Universitari de Girona Doctor Josep Trueta

Girona, Catalonia, 17007, Spain

Location

Hospital Universitari Arnau de Vilanova de Lleida

Lleida, Catalonia, 25198, Spain

Location

Hospital Universitari Joan XXIII de Tarragona

Tarragona, Catalonia, 43005, Spain

Location

Related Publications (9)

• 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.

  PMID: 30978731 BACKGROUND

• 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.

  PMID: 28385194 BACKGROUND

• 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.

  PMID: 26077453 BACKGROUND

• 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.

  PMID: 25961444 BACKGROUND

• 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.

  PMID: 21872716 BACKGROUND

• 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.

  PMID: 24238309 BACKGROUND

• 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.

  PMID: 27022723 BACKGROUND

• 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.

  PMID: 32219785 BACKGROUND

• 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.

  PMID: 37263361 DERIVED

MeSH Terms

Interventions

Electrosurgery

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• 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.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: August 11, 2017
• Study Start: March 31, 2017
• Primary Completion: April 30, 2020
• Study Completion: March 30, 2021
• Last Updated: September 7, 2022

Record last verified: 2022-09

Locations

ES (7)