Evaluation of Superior Rectal Arterial Embolization in Hemorrhoidal Disease

Universitair Ziekenhuis Brussel

Status: Enrolling

Conditions: Hemorrhoids

Treatments: Procedure: Superior Rectal Artery Embolization (SRAE); Procedure: Rubber band ligatures (RBL); Procedure: Doppler-Guided Hemorrhoidal Artery Ligation (DG-HAL)

Study type: Interventional

Funder types: Other

Identifiers

NCT05697562

HEMbol

Details and patient eligibility

About

SRAE is a promising treatment of bleeding HD as a minimally invasive approach without sphincter damage nor direct mucosal anorectal trauma. Feasibility, efficacy and safety were studied in several trials. A randomized controlled study should confirm the benefits of this technique and will define its therapeutic role in HD.

Embolization and DG-HAL are based on the same concept of vascular occlusion of hemorrhoidal branches of the rectal artery. Furthermore, DG-HAL and RBL are equally effective procedures. The assumption is that treatment with SRAE is not inferior in comparison to RBL or DG HAL in respectively patients without or with antiplatelet/anticoagulation therapy in terms of symptom control and bleeding (non-inferiority study).

Full description

Hemorrhoidal disease (HD) is the most common anorectal pathology. Therapeutic management of HD ranges from conservative treatment and instrumental treatment to surgical approach. Beside these, certain minimally invasive techniques such as radiofrequency ablation, laser coagulation and Superior Rectal Artery Embolization (SRAE) are gaining interest. SRAE is a promising treatment of bleeding HD as a minimally invasive approach without sphincter damage nor direct mucosal anorectal trauma. Feasibility, efficacy and safety were studied in several trials. A randomized controlled study should confirm the benefits of this technique and will define its therapeutic role in HD. Embolization and DG-HAL are based on the same concept of vascular occlusion of hemorrhoidal branches of the rectal artery. Furthermore, DG-HAL and RBL are equally effective procedures. The assumption is that treatment with SRAE is not inferior in comparison to RBL or DG HAL in respectively patients without or with antiplatelet/anticoagulation therapy in terms of symptom control and bleeding (non-inferiority study).

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients referred for Hemorrhoidal disease with bleeding are eligible. Significant bleeding is defined as a HBS of ≥ 5.
• Age > 18 years old;
• Sexes eligible for study: all
• Hemorrhoidal disease grade I-III according the Goligher classification with rectal bleeding as predominant symptom
• History of prior instrumental treatment of HD does not prohibit inclusion
• Able to understand and read Dutch, French or English

Exclusion criteria

• Permanent hemorrhoidal prolapse/grade IV hemorrhoidal disease
• Rectal prolapse
• History of proctological surgery for HD
• Acute complicated course of HD i.e. acute thrombosis (fluxio hemorrhoidalis or perianal hematoma)
• Anal stenosis, congenital of acquired
• Chronic anal fissure
• Active rectal inflammation, including peri-anal abscess (e.g. Inflammatory Bowel Disease, infectious,…)
• History of colorectal or anal cancer
• History of rectal or sigmoidal resection
• Portal hypertension and liver cirrhosis Child Pugh C
• Radiation rectitis
• Neurological disease involving anal sphincter musculature
• Severe psychiatric disorder
• Pregnancy
• Allergy to iodinated contrast agents
• Colorectal neoplasia as the cause of bleeding (excluded with a (virtual) colonoscopy in the last year)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups, including a placebo group

anticoagulation group with DG HAL

Placebo Comparator group

Treatment:

Procedure: Doppler-Guided Hemorrhoidal Artery Ligation (DG-HAL)

anticoagulation group with SRAE

Active Comparator group

Treatment:

Procedure: Superior Rectal Artery Embolization (SRAE)

no anticoagulation group with RBL

Placebo Comparator group

Treatment:

Procedure: Rubber band ligatures (RBL)

no anticoagulation group with SRAE

Active Comparator group

Treatment:

Procedure: Superior Rectal Artery Embolization (SRAE)