Clinical trial NCT03740321: SRAE With Embospheres for Hemorrhoids.
Official title: Superior Rectal Artery Embolization With Tri-acryl Gelatin Particles for Treatment of Symptomatic Hemorrhoids: Safety and Efficacy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Embolization
Hemorrhoids
Keywords: Hemorrhoids
Superior rectal artery
embolization
microspheric particles
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2018-11-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Blocked randomized, single blind, prospective study
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of procedure related mortality (safety)
timeFrame: 12 month
measure: Incidence of procedure related complications (safety)
timeFrame: 12 month
measure: Incidence of the patients' being free of symptoms from hemorrhoidal disease (efficacy)
timeFrame: 12 month
Secondary outcomes:
measure: Technical success
timeFrame: On the day of intervention
measure: Recurrence
timeFrame: 3-6-12. months
Other outcomes:
Locations:
city: Eskişehir
country: Turkey
facility: Eskisehir Osmangazi University, Faculty of Medicine, Department of Interventional Radiology
Study officials:
affiliation: Eskisehir Osmangazi University, Faculty of Medicine, Department of Interventional Radiology
name: Fahrettin Kucukay
role: STUDY_CHAIR
References:
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 Imaging. 2016 Nov;97(11):1079-1084. doi: 10.1016/j.diii.2016.08.002. Epub 2016 Aug 31.
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: 10.1007/s00270-014-1017-8. Epub 2014 Nov 4.
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 2014 Feb 28.
citation: 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.
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.2018.01.778. Epub 2018 Apr 30.
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 application of the "emborrhoid" technique. Tech Coloproctol. 2018 Jun;22(6):453-455. doi: 10.1007/s10151-018-1802-5. Epub 2018 May 24. No abstract available.
citation: Primo Romaguera V, Gregorio Hernandez A, Andreo Hernandez L, de la Morena Valenzuela E. Selective embolization of the superior rectal artery: An alternative to hemorrhoid surgery? Cir Esp (Engl Ed). 2018 Apr;96(4):239-241. doi: 10.1016/j.ciresp.2017.08.005. Epub 2017 Oct 14. No abstract available. English, Spanish.