ARTerial EMbolization for haemorrhoIdal Disease (ART.EM.I. Study) (ARTEMIS)

ARTerial EMbolization for haemorrhoIdal Disease Study

Haemorrhoidal disease is amongst the most common rectal conditions causing significant distress to the affected patients. Current surgical techniques for the treatment of internal haemorrhoids are associated with several drawbacks and sometimes high recurrence rates. The purpose of this study is to assess the safety and efficacy of a new minimally invasive technique that is based on blocking the arteries that feed the haemorrhoids and thus potentially leading to a decrease in their size. A recently published paper with 14 patients showed good results in terms of safety(Vidal et. al.). Despite the promising preliminary evidence, there is still a need for more studies and additional data. Furthermore, at the current time, there are no studies assessing quality of life changes post embolisation for these patients and the investigators hope to evaluate this important aspect of treatment as well.

This study will provide the investigators with results regarding the efficacy and safety of arterial embolisation for advanced haemorrhoid disease. This will be the first study to provide data on short and long term efficacy (in terms of re-bleeding and re-operation rates) as well as to provide evidence on the effect of this novel treatment on quality of life. This study will also be the largest study to date and if successful will pave the way for a large randomised controlled trial comparing the gold standard surgical treatment to the embolisation treatment.

The embolisation of haemorrhoid vessel is not an experimental technique and it has been used in the past in cases of uncontrollable hemorrhoidal- related bleeding with good results and without morbidity. However, this is the first time that the investigators will use this technique as a first line treatment for haemorrhoids and part of this study is to assess the feasibility and safety of this approach.

Study Overview

• Status: Withdrawn
• Conditions: Haemorrhoidal Bleeding
• Intervention / Treatment: Procedure: Coil embolisation of hemorrhoidal arteries.

Detailed Description

This is a pilot, prospective, single arm and single centre trial to assess the safety and efficacy of haemorrhoid embolisation. Patients with advanced hemorrhoidal disease (grade II-IV) will be identified through the colorectal clinic with a recruitment target of 24 patients. The duration of patient participation in this study is 24 months. During this time the patient will have to attend 4 appointments (including the treatment session).

All cases in this study will be performed as day case procedures. The patients will be admitted to the interventional radiology day unit in the morning, where a standard pre-assessment will take place. The main intervention will be the embolisation of their hemorrhoidal arteries. The embolisation will be performed using a standard approach with a right femoral puncture and after inserting a 5 Fr introducer sheath. The inferior mesenteric artery will be catheterized using a Simmons catheter (radiofocus-Terumo). The superior rectal arteries will be then catheterized with a rapid transit microcatheter Progreat microcatheter (Radiofocus-Terumo) and then embolised with a number of coils. The arteries will be packed with coils until there is complete blood flow stasis within the target artery bilaterally. The technical success of the procedure will be assessed by achieving stasis of blood flow distally to the site of the embolisation. This will be assessed fluoroscopically. CE marked coils will be used for the embolisation of the arteries feeding the haemorrhoids.

Following the procedure, patients will be discharged to their usual place of residence after 6 hours of observations in the interventional radiology day unit. The patients will be followed up in the colorectal clinic after 3 months, 12 months and 24 months.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Oxford, United Kingdom, OX3 9DU
    • Department of Interventional Radiology, John Radcliffe Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

i. Adult male and female patients between the ages of 40-90 years old.

ii. Patients with grade II-IV haemorrhoid disease with re-current or active bleeding AND

iii. Patients with (ii) who do not wish to undergo surgery for their symptoms OR

iv. Patients with (ii) despite previous surgery.

v. Patients who can understand and sign the consent form.

Exclusion Criteria:

i. Patients who are not otherwise fit for surgery.

ii. Patients with significant ano-rectal comorbidities (cancer, fistula, abscesses).

iii. Patients who are unable to sign the inform consent form.

iv. Pregnancy.

v. Patients with history of significant colorectal disease or previous colectomy.

vi. Iodine allergy/ Contrast allergy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment arm; The treatment arm will undergo the intervention with embolisation of their hemorrhoidal arteries. The embolisation will be performed using a standard right femoral puncture and after inserting a 5 Fr introducer sheath. The inferior mesenteric artery will be catheterised using a Simmons catheter (radiofocus-Terumo). The superior rectal arteries will be then catheterized with a rapid transit microcatheter Progreat microcatheter (Radiofocus-Terumo) and embolised with coils. The treatment will include the use of fluoroscopy for which the radiation protection department of Oxford University Hospitals NHS Foundation Trust has been consulted. The technical success of the procedure will be assessed fluoroscopically by achieving stasis of blood flow distally to the site of the embolization. CE marked coils will be used for the embolisation of the arteries feeding the haemorrhoids.

Procedure: Coil embolisation of hemorrhoidal arteries.; Coil embolisation of hemorrhoidal arteries as previously described.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the clinical success of the procedure	Resolution of symptoms 1 year after operation is the primary endpoint. This will be assessed with a previously validated patient questionnaire of bowel function (Nyström et. al.). Five questions about haemorrhoidal symptoms will be appended while retaining the structure of the questionnaire. Patients will also submit a health-related quality-of-life questionnaire (SF-12 Form). Questionnaires will be completed before the operation, at 3, 12 and 24 months follow-up.	Pre-operative (day of procedure) 3, 12, and 24 months post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the technical success of the procedure	The technical success of the procedure will be assessed by achieving stasis of blood flow distally to the site of the embolization. This will be assessed fluoroscopically.	Day of procedure (immediately at time of procedure)
To assess the safety of the procedure and potential side effects	Post-operative pain will be recorded by the patient after operation. The pain experienced during most of the day and a peak pain will be recorded straight after the procedure and using a ten point visual analogue scale (VAS) (0, no pain; 10, worst pain imaginable). Side effects and potential complications related to the procedure will be documented in the case report form.	Immediately post-procedure, 3, 12 and 24 months post-operatively

Collaborators and Investigators

• Sponsor: Oxford University Hospitals NHS Trust
• Investigators: Principal Investigator: Raman Uberoi, FRCR, John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Headington, Oxford OX3 9DU

Publications and helpful links

General Publications

• 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.
• Nystrom PO, Qvist N, Raahave D, Lindsey I, Mortensen N; Stapled or Open Pile Procedure (STOPP) trial study group. Randomized clinical trial of symptom control after stapled anopexy or diathermy excision for haemorrhoid prolapse. Br J Surg. 2010 Feb;97(2):167-76. doi: 10.1002/bjs.6804.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2020
• Primary Completion (Actual): May 24, 2022
• Study Completion (Actual): May 24, 2022

Study Registration Dates

• First Submitted: December 21, 2020
• First Submitted That Met QC Criteria: December 21, 2020
• First Posted (Actual): December 24, 2020

Study Record Updates

• Last Update Posted (Actual): August 18, 2022
• Last Update Submitted That Met QC Criteria: August 16, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: haemorrhoid; embolisation
• Other Study ID Numbers: 12397

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes