SRAE With Embospheres for Hemorrhoids.

Hemorrhoids Clinical Trial

Official title:

Superior Rectal Artery Embolization With Tri-acryl Gelatin Particles for Treatment of Symptomatic Hemorrhoids: Safety and Efficacy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03740321
• Other study ID #: 80558721/237
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: December 1, 2020

Study information

• Verified date: November 2018
• Source: Eskisehir Osmangazi University
• Contact: Fahrettin Kucukay, Prof.
• Phone: +905325875318
• Email: fkucukay[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study , safety and efficacy of superior rectal artery embolization with embospheres will be researched prospectively.

Description:

Symptomatic hemorrhoidal disease is a still important public health problem although there are many surgical and nonsurgical minimal invasive treatment methods. Treatment methods are not satisfactory or invasive in some percent of the patients. Superior rectal artery embolization(SRAE) for hemorrhoids is an adapted technique derived from Doppler-guided hemorrhoidal artery ligation (DGHAL). In this technique, the distal branches of the superior rectal artery arising from the inferior mesenteric artery is occluded endovascularly with coils. Its feasibility and safety were supported by articles. Collateralization and recurrence was seen following coil embolization. To prevent this , tri-acryl gelatin microspheres in 500-700 and 700-900 micrometers in size will be used. Safety and efficacy of embolization and using different sized particles will be evaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients with symptoms of hemorrhoidal disease

• Patients with written informed consent

• Patients refusing surgery or other interventional methods

• Patients with high risk for surgery

• Patients accepting follow ups

Exclusion Criteria:

• Previous intervention

• Colorectal diseases other than hemorrhoids

• Patients with anal stenosis

• Patients with rectal prolapsus

• pregnant patients

• Patients with contraindications for technical steps or contrast usage.

• Patients do nor or could not give written informed consent

Related Conditions & MeSH terms

• Embolization
• Hemorrhoids

Intervention

Device:
• Embolization with tri-acryl gelatin (Embosphere) particles
Left, right and posterior branches of superior rectal artery will be embolized with tri-acryl gelatin particles in 500-700 and 700-900 micrometers in size until homeostasis will be achieved.

Locations

Country	Name	City	State
Turkey	Eskisehir Osmangazi University, Faculty of Medicine, Department of Interventional Radiology	Eskisehir

Sponsors (1)

Lead Sponsor	Collaborator
Eskisehir Osmangazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

Galkin E. [X-ray endovascular embolization of the superior rectal artery: New potentialities in the surgical management of chronic hemorrhoids]. Vestn Rentgenol Radiol. 2001 Nov-Dec;(6):44-9. Russian. — View Citation

Primo Romaguera V, Gregorio Hernández A, Andreo Hernández L, de la Morena Valenzuela E. Selective embolization of the superior rectal artery: An alternative to hemorrhoid surgery? Cir Esp. 2018 Apr;96(4):239-241. doi: 10.1016/j.ciresp.2017.08.005. Epub 20 — View Citation

Tradi F, Louis G, Giorgi R, Mege D, Bartoli JM, Sielezneff I, Vidal V. Embolization of the Superior Rectal Arteries for Hemorrhoidal Disease: Prospective Results in 25 Patients. J Vasc Interv Radiol. 2018 Jun;29(6):884-892.e1. doi: 10.1016/j.jvir.2018.01. — View Citation

Venturini M, De Nardi P, Marra P, Panzeri M, Brembilla G, Morelli F, Melchiorre F, De Cobelli F, Del Maschio A. Embolization of superior rectal arteries for transfusion dependent haemorrhoidal bleeding in severely cardiopathic patients: a new field of app — View Citation

Vidal V, Louis G, Bartoli JM, Sielezneff I. Embolization of the hemorrhoidal arteries (the emborrhoid technique): a new concept and challenge for interventional radiology. Diagn Interv Imaging. 2014 Mar;95(3):307-15. doi: 10.1016/j.diii.2014.01.016. Epub — View Citation

Vidal V, Sapoval M, Sielezneff Y, De Parades V, Tradi F, Louis G, Bartoli JM, Pellerin O. Emborrhoid: a new concept for the treatment of hemorrhoids with arterial embolization: the first 14 cases. Cardiovasc Intervent Radiol. 2015 Feb;38(1):72-8. doi: 10. — View Citation

Zakharchenko A, Kaitoukov Y, Vinnik Y, Tradi F, Sapoval M, Sielezneff I, Galkin E, Vidal V. Safety and efficacy of superior rectal artery embolization with particles and metallic coils for the treatment of hemorrhoids (Emborrhoid technique). Diagn Interv — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of procedure related mortality (safety)	The mortality rate among the patients during 12 months related with interventional procedure.	12 month
Primary	Incidence of procedure related complications (safety)	The morbidity rate among the patients during 12 months related with interventional procedure.	12 month
Primary	Incidence of the patients' being free of symptoms from hemorrhoidal disease (efficacy)	The efficacy and clinical success of the procedure will be evaluated	12 month
Secondary	Technical success	The rate of interventions that were performed successfully.	On the day of intervention
Secondary	Recurrence	Recanalization or collateralization of the previously embolized rectal arteries.	3-6-12. months

External Links

•   Device descriptions, Instructions for use