Evaluation of Superior Rectal Arterial Embolization in Hemorrhoidal Disease

Study Overview
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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).

Official Title
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A Randomized Comparative Evaluation of Superior Rectal Arterial Embolization in Hemorrhoidal Disease

Conditions
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Hemorrhoids

Intervention / Treatment
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* Procedure: Rubber band ligatures (RBL)
* Procedure: Superior Rectal Artery Embolization (SRAE)
* Procedure: Doppler-Guided Hemorrhoidal Artery Ligation (DG-HAL)


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: anticoagulation group with DG HAL<br> | Procedure: Doppler-Guided Hemorrhoidal Artery Ligation (DG-HAL)<br>* 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.<br>|
| Active Comparator: anticoagulation group with SRAE<br> | Procedure: Superior Rectal Artery Embolization (SRAE)<br>* 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.<br>|
| Placebo Comparator: no anticoagulation group with RBL<br> | Procedure: Rubber band ligatures (RBL)<br>* 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.<br>|
| Active Comparator: no anticoagulation group with SRAE<br> | Procedure: Superior Rectal Artery Embolization (SRAE)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom control | a secondary objective is to control the symptoms, for this the Hemorrhoidal Bleeding Score is to be used | from baseline to 12 months | 
| Patient reported effectiveness | a secondary objective is to report patient effectiveness, this will be measured using Patient-Reported Outcome Measure-Haemorrhoidal Impact and Satisfaction score (PROM-HISS) | from baseline till 12 months | 
| Patient reported effectiveness | a secondary objective is to report patient effectiveness, this will be measured using the 5-level EQ-5D-5L score | from baseline till 12 months | 
| clinical effectiveness | a secondary objective is to report clinical effectiveness, this will be measured using the Goligher score | from baseline till 12 months | 
| prevalence of complications | a secondary objective is to report the prevalence of complications, this will be measured using among others the pain score reported by Visual Analogue Scale (VAS) | from baseline till 12 months | 
| prevalence of re-interventions | a secondary objective is to report the prevalence of re-interventions, this will be measured among others with the pain score reported by Visual Analogue Scale (VAS) | from baseline till 12 months | 
| prevalence of fecal incontinence | a secondary objective is to report the prevalence of fecal incontinence, this will be measured using the Jorge-wexner score | from baseline till 12 months |