Banding Without Resection in Small Subepithelial Tumours

Gastrointestinal Subepithelial Tumors Clinical Trial

— BANDING-SET  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03247231
• Other study ID #: BANDING-SET
• Status: Terminated
• Start date: March 31, 2017
• Est. completion date: March 30, 2021

Study information

• Verified date: September 2022
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 157
• Est. completion date: March 30, 2021
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastrointestinal Subepithelial Tumors
• Neoplasms

Intervention

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

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

Locations

Country	Name	City	State
Spain	Hospital Universitari Germans Trias i Pujol (Can Ruti)	Badalona	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 de Bellvitge	L'Hospitalet de Llobregat	Barcelona, Catalonia
Spain	Hospital Universitari Arnau de Vilanova de Lleida	Lleida	Catalonia
Spain	Hospital Universitari Joan XXIII de Tarragona	Tarragona	Catalonia
Spain	Hospital Universitari Mútua de Terrassa	Terrassa	Barcelona, Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Joan B Gornals

Country where clinical trial is conducted

Spain, 

References & Publications (8)

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. — View Citation

Bas-Cutrina F, Ballester-Clau R, González-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. — View 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. — View 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. Erratum in: Gastrointest Endosc. 2014 Jul;80(1):196. — View Citation

de la Serna-Higuera C, Pérez-Miranda M, Díez-Redondo P, Gil-Simón P, Herranz T, Pérez-Martín E, Ochoa C, Caro-Patón 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. — View Citation

Ibáñez-Sanz G, Gornals JB, Rivas L, Salord S, Paúles MJ, Botargues JM, Galán 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Number of participants with treatment-related adverse events as assessed by American Society of Gastrointestinal Endoscopy (ASGE) guideline.	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
Secondary	Technical success.	Correct application of elastic banding.	First day
Secondary	SINK biopsy efectiveness.	Positive definitve pathological result rate of single-incision needle-knife (SINK) biopsies permorfed in subeptihelial tumours ligated.	4-6 weeks
Secondary	Long-term recurrence.	Recurrence of indeterminate or pre-malignant subepithelial tumours rate at 5 years by endoscopic ultrasonography control.	5 years