Not provided
Not provided
Not provided
Not provided
Not provided
Due to SARS-CoV2 (Covid-19) pandemia
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To analyse the effectiveness and safety of endoscopic band ligation without resection in small gastrointestinal subepithelial tumours.
Multicenter prospective study analysing the effectiveness and safety of endoscopic band ligation without resection in small (â€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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic band ligation without resection | Device | Endoscopic treatment of subepithelial tumors: autoamputation by endoscopic band ligation without resection. |
| |
| SINK | Procedure | To obtain sample tissue biopsies after the endoscopic band ligation without resection, performing a single-incision with a needle-knife. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Removal of the subepithelial tumour (global clinical success). | Complete removal and disappearance of the subepithelial tumour at 1 year by endoscopic ultrasonography control. | 1 year |
| Number of participants with treatment-related adverse events as assessed by American Society of Gastrointestinal Endoscopy (ASGE) guideline. |
Not provided
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Not provided
Not provided
Patients with subepithelial lesions (SEL) in the gastrointestinal tract.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Germans Trias i Pujol (Can Ruti) | Badalona | Barcelona, Catalonia | 08916 | Spain | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30978731 | Background | 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. | |
| 28385194 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004598 | Electrosurgery |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
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). |
| 1 year |
| Technical success. | Correct application of elastic banding. | First day |
| SINK biopsy efectiveness. | Positive definitve pathological result rate of single-incision needle-knife (SINK) biopsies permorfed in subeptihelial tumours ligated. | 4-6 weeks |
| Long-term recurrence. | Recurrence of indeterminate or pre-malignant subepithelial tumours rate at 5 years by endoscopic ultrasonography control. | 5 years |
| Hospital Universitari de Bellvitge |
| L'Hospitalet de Llobregat |
| Barcelona, Catalonia |
| 08907 |
| Spain |
| Hospital Universitari MĂștua de Terrassa | Terrassa | Barcelona, Catalonia | 08221 | Spain |
| Hospital de Sant Pau i de la Santa Creu | Barcelona | Catalonia | 08041 | Spain |
| Hospital Universitari de Girona Doctor Josep Trueta | Girona | Catalonia | 17007 | Spain |
| Hospital Universitari Arnau de Vilanova de Lleida | Lleida | Catalonia | 25198 | Spain |
| Hospital Universitari Joan XXIII de Tarragona | Tarragona | Catalonia | 43005 | Spain |
| 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. |
| 26077453 | 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. |
| 25961444 | 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. |
| 21872716 | 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. |
| 24238309 | 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. |
| 27022723 | 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. |
| 32219785 | 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. |
| 37263361 | Derived | 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. |