Evaluation of Superior Rectal Arterial Embolization in Hemorrhoidal Disease

NCT05697562 | Recruiting

• 1 other identifier: HEMbol
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Hemorrhoids

Outcome Measures

Primary Outcomes (1)

• symptom control

  the main objective is to control the symptoms, for this the Hemorrhoidal Bleeding Score is to be used

  from baseline to 3 months

Secondary Outcomes (7)

• Symptom control

  from baseline to 12 months

• Patient reported effectiveness

  from baseline till 12 months

• Patient reported effectiveness

  from baseline till 12 months

• clinical effectiveness

  from baseline till 12 months

• prevalence of complications

  from baseline till 12 months

Study Arms (4)

anticoagulation group with DG HAL

PLACEBO COMPARATOR

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

anticoagulation group with SRAE

ACTIVE COMPARATOR

Procedure: Superior Rectal Artery Embolization (SRAE)

no anticoagulation group with RBL

PLACEBO COMPARATOR

Procedure: Rubber band ligatures (RBL)

no anticoagulation group with SRAE

ACTIVE COMPARATOR

Procedure: Superior Rectal Artery Embolization (SRAE)

Interventions

Superior Rectal Artery Embolization (SRAE) PROCEDURE

This technique is realized under local anesthesia during a one-day hospitalization. The interventional radiologist will perform the procedure in the angiography room. After local anesthesia right femoral artery puncture is performed and a 4 F or 5 F introducer sheath is placed using the Seldinger technique. With an appropriate 4 or 5 F catheter the superior rectal artery is catheterized. With a microcatheter the different branches are selectively occluded with microcoils. The endpoint of embolization is reached when all SRA branches above the pubic ramus are embolized, with cessation of flow distally or a static column of contrast. The procedure can be repeated with addition of the embolization of the middle rectal wall artery (MRA) in case of failure after 12 weeks.

anticoagulation group with SRAE; no anticoagulation group with SRAE

Doppler-Guided Hemorrhoidal Artery Ligation (DG-HAL) PROCEDURE

The procedure is performed in lithotomy position with a modified proctoscope including a Doppler transducer (THD device) under anesthesia during a one-day hospitalization. This transanal Doppler guidance enables accurate detection and targeted suture ligation of the SRAs Following gel lubrication, the proctoscope is inserted through the anal canal reaching the low rectum, about 6-7 cm from the anal verge. After identification of the best place for artery ligation, the Doppler system is turned off. The artery will be directly ligated with a Z-stitch at the site of the best Doppler signal.

anticoagulation group with DG HAL

Rubber band ligatures (RBL) PROCEDURE

This instrumental technique is realized during consultation. A rubber band is applied on top of each hemorrhoidal complex via a proctoscope. This banding causes an ulceration which heals with resulting fibrosis. The patient can receive a maximum of 3 RBL during each session, which can be repeated up to 3 times at a 6 weeks interval.

no anticoagulation group with RBL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Able to understand and read Dutch, French or English

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Jette, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Magali Surmont

CONTACT

+32 2 477; magali.surmont@uzbrussel.be

Virgini Van Buggenhout

CONTACT

+32 2 477; virgini.vanbuggenhout@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be divided in 2 groups: Anticoagulation group (A) and No Anticoagulation group (NA), based on their regular medication. In both groups, A and NA, are 2 study arms, resp. DG HAL as standard clinical practice versus SRAE (group A) and RBL as standard clinical practice versus SRAE (arm NA). See figure below.

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 26, 2023
• Study Start: June 1, 2023
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)