Banding Without Resection in Small Subepithelial Tumours
NCT ID: NCT03247231
Last Updated: 2022-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
157 participants
OBSERVATIONAL
2017-03-31
2021-03-30
Brief Summary
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Detailed Description
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This endoscopic technique will be complemented with a SINK (single-incision needle-knife) biopsy for ensuring the pathological diagnosis of the treated subepithelial tumour.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Endoscopic band ligation without resection
Endoscopic treatment of subepithelial tumors: autoamputation by endoscopic band ligation without resection.
SINK
To obtain sample tissue biopsies after the endoscopic band ligation without resection, performing a single-incision with a needle-knife.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
80 Years
ALL
No
Sponsors
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Joan B Gornals
OTHER
Responsible Party
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Joan B Gornals
Principal investigator
Principal Investigators
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Joan B Gornals, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Endoscopy Unit; Digestive Diseases Department; H. Universitari de Bellvitge.
Francesc Bas-Cutrina, MD
Role: PRINCIPAL_INVESTIGATOR
Endoscopy Unit; Digestive Diseases Department; H. Universitari de Bellvitge.
Locations
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Hospital Universitari Germans Trias i Pujol (Can Ruti)
Badalona, Barcelona, Catalonia, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Catalonia, Spain
Hospital Universitari Mútua de Terrassa
Terrassa, Barcelona, Catalonia, Spain
Hospital de Sant Pau i de la Santa Creu
Barcelona, Catalonia, Spain
Hospital Universitari de Girona Doctor Josep Trueta
Girona, Catalonia, Spain
Hospital Universitari Arnau de Vilanova de Lleida
Lleida, Catalonia, Spain
Hospital Universitari Joan XXIII de Tarragona
Tarragona, Catalonia, Spain
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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BANDING-SET
Identifier Type: -
Identifier Source: org_study_id
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