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In this study , safety and efficacy of superior rectal artery embolization with embospheres will be researched prospectively.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Embospheres 500-700 microns | Experimental | Intervention.Embolization with 500-700 micron particles will be performed with 1 ml vials. Embolization procedure will be continued with vials until the stasis in SRAE will be achieved. Procedure will be performed only one time. |
|
| Embospheres 700-900 microns | Experimental | Intervention.Embolization with 700-900 micron particles will be performed with 1 ml vials. Embolization procedure will be continued with vials until the stasis in SRAE will be achieved. Procedure will be performed only one time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Embolization with tri-acryl gelatin (Embosphere) particles | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of procedure related mortality (safety) | The mortality rate among the patients during 12 months related with interventional procedure. | 12 month |
| Incidence of procedure related complications (safety) | The morbidity rate among the patients during 12 months related with interventional procedure. | 12 month |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | The rate of interventions that were performed successfully. | On the day of intervention |
| Recurrence | Recanalization or collateralization of the previously embolized rectal arteries. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fahrettin Kucukay, Prof. | Contact | +905325875318 | fkucukay@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Fahrettin Kucukay | Eskisehir Osmangazi University, Faculty of Medicine, Department of Interventional Radiology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eskisehir Osmangazi University, Faculty of Medicine, Department of Interventional Radiology | Recruiting | Eskişehir | 26450 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27597728 | Result | 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. | |
| 25366092 |
| Label | URL |
|---|---|
| Device descriptions, Instructions for use | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 15, 2017 | Nov 9, 2018 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D006484 | Hemorrhoids |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D004621 | Embolization, Therapeutic |
| ID | Term |
|---|---|
| D006489 | Hemostatic Techniques |
| D013812 | Therapeutics |
| D060205 | Therapeutic Occlusion |
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Blocked randomized, single blind, prospective study
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|
| 3-6-12. months |
| 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. |
| 24589187 | Result | 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. |
| 11858033 | Result | 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. |
| 29724519 | Result | 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. |
| 29797246 | Result | 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. |
| 29042023 | Result | 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |