Clinical trial NCT03247231: Banding Without Resection in Small Subepithelial Tumours
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
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
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2017-08-11
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with subepithelial lesions (SEL) in the gastrointestinal tract.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Removal of the subepithelial tumour (initial clinical success).
timeFrame: 4-6 weeks
Secondary outcomes:
measure: Removal of the subepithelial tumour (global clinical success).
timeFrame: 1 year
measure: Number of participants with treatment-related adverse events as assessed by American Society of Gastrointestinal Endoscopy (ASGE) guideline.
timeFrame: 1 year
measure: Technical success.
timeFrame: First day
measure: SINK biopsy efectiveness.
timeFrame: 4-6 weeks
measure: Long-term recurrence.
timeFrame: 5 years
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol (Can Ruti)
state: Barcelona, Catalonia
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona, Catalonia
city: Terrassa
country: Spain
facility: Hospital Universitari Mútua de Terrassa
state: Barcelona, Catalonia
city: Barcelona
country: Spain
facility: Hospital de Sant Pau i de la Santa Creu
state: Catalonia
city: Girona
country: Spain
facility: Hospital Universitari de Girona Doctor Josep Trueta
state: Catalonia
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova de Lleida
state: Catalonia
city: Tarragona
country: Spain
facility: Hospital Universitari Joan XXIII de Tarragona
state: Catalonia
Study officials:
affiliation: Endoscopy Unit; Digestive Diseases Department; H. Universitari de Bellvitge.
name: Joan B Gornals, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Endoscopy Unit; Digestive Diseases Department; H. Universitari de Bellvitge.
name: Francesc Bas-Cutrina, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.