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

NCT04684251 | Withdrawn

• 1 other identifier: 12397
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Haemorrhoidal Bleeding

Keywords

haemorrhoid; embolisation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• To assess the technical success of the procedure

  Day of procedure (immediately at time of procedure)

• To assess the safety of the procedure and potential side effects

  Immediately post-procedure, 3, 12 and 24 months post-operatively

Study Arms (1)

Treatment arm

EXPERIMENTAL

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.

Interventions

Coil embolisation of hemorrhoidal arteries. PROCEDURE

Coil embolisation of hemorrhoidal arteries as previously described.

Treatment arm

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead

Study Sites (1)

Department of Interventional Radiology, John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 24589187 BACKGROUND

• 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.

  PMID: 20035531 BACKGROUND

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

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

Study Officials

• Raman Uberoi, FRCR

  John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Headington, Oxford OX3 9DU

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 24, 2020
• Study Start: November 25, 2020
• Primary Completion: May 24, 2022
• Study Completion: May 24, 2022
• Last Updated: August 18, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)