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Evaluation of Superior Rectal Arterial Embolization in Hemorrhoidal Disease

NCT ID: NCT05697562

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2030-12-31

Brief Summary

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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).

Detailed Description

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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).

Conditions

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Hemorrhoids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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anticoagulation group with DG HAL

Group Type PLACEBO_COMPARATOR

Doppler-Guided Hemorrhoidal Artery Ligation (DG-HAL)

Intervention Type 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 SRAE

Group Type ACTIVE_COMPARATOR

Superior Rectal Artery Embolization (SRAE)

Intervention Type 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.

no anticoagulation group with RBL

Group Type PLACEBO_COMPARATOR

Rubber band ligatures (RBL)

Intervention Type 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 SRAE

Group Type ACTIVE_COMPARATOR

Superior Rectal Artery Embolization (SRAE)

Intervention Type 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.

Interventions

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Rubber band ligatures (RBL)

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.

Intervention Type PROCEDURE

Superior Rectal Artery Embolization (SRAE)

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.

Intervention Type PROCEDURE

Doppler-Guided Hemorrhoidal Artery Ligation (DG-HAL)

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UZ Brussel

Jette, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Magali Surmont

Role: CONTACT

Phone: +32 2 477

Email: [email protected]

Virgini Van Buggenhout

Role: CONTACT

Phone: +32 2 477

Email: [email protected]

Facility Contacts

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Magali Surmont

Role: primary

Other Identifiers

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HEMbol

Identifier Type: -

Identifier Source: org_study_id