Clinical trial · Observational
Banding Without Resection in Small Subepithelial Tumours
Effectiveness and Safety of the Endoscopic Band Ligation Without Resection of ≤15-mm Subepithelial Tumours of the Digestive Tract: a Multicenter Prospective Study
NCT03247231CI-TRIAL-00060706BANDING-SETterminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to SARS-CoV2 (Covid-19) pandemia
Summary
Brief summary (as posted)
To analyse the effectiveness and safety of endoscopic band ligation without resection in small gastrointestinal subepithelial tumours.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Subepithelial Tumors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic band ligation without resection | Device | — | UNRESOLVED |
| SINK | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Removal of the subepithelial tumour (initial clinical success).
- timeFrame
- 4-6 weeks
- description
- Complete removal and disappearance of the subepithelial tumour at 4-6 weeks by endoscopic ultrasonography control.
Secondary outcomes (5)
- measure
- Removal of the subepithelial tumour (global clinical success).
- timeFrame
- 1 year
- description
- Complete removal and disappearance of the subepithelial tumour at 1 year by endoscopic ultrasonography control.
- measure
- Number of participants with treatment-related adverse events as assessed by American Society of Gastrointestinal Endoscopy (ASGE) guideline.
- timeFrame
- 1 year
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (9)
- BACKGROUNDBas-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
- BACKGROUNDStandards 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
- BACKGROUNDASGE 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
- BACKGROUNDSong 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
- BACKGROUNDde 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
- BACKGROUNDBinmoeller 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.