Haemorrhoidal BleedingARTEMISNCT04684251
ARTerial EMbolization for haemorrhoIdal Disease (ART.EM.I. Study)
A study testing Coil embolisation of hemorrhoidal arteries. in people with Haemorrhoidal Bleeding, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Haemorrhoidal Bleeding
- What is being tested?
- Coil embolisation of hemorrhoidal arteries.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Nov 2020to 24 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male and female patients between the ages of 40-90 years old.
- Patients with grade II-IV haemorrhoid disease with re-current or active bleeding AND
- Patients with (ii) who do not wish to undergo surgery for their symptoms OR
- Patients with (ii) despite previous surgery.
- Patients who can understand and sign the consent form.
Who cannot join
- Patients who are not otherwise fit for surgery.
- Patients with significant ano-rectal comorbidities (cancer, fistula, abscesses).
- Patients who are unable to sign the inform consent form.
- Pregnancy.
- Patients with history of significant colorectal disease or previous colectomy.
- Iodine allergy/ Contrast allergy.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Interventional Radiology, John Radcliffe Hospital
Oxford, OX3 9DU
About this study
Official title: 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.
Read the 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.
- Conditions
- Haemorrhoidal Bleeding
- Being tested
- Coil embolisation of hemorrhoidal arteries.
- Keywords
- haemorrhoid, embolisation
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coil embolisation of hemorrhoidal arteries.Procedure or surgery
Coil embolisation of hemorrhoidal arteries as previously described.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Coil embolisation of hemorrhoidal arteries. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-operative (day of procedure) 3, 12, and 24 months post-operatively
Secondary outcomes (2)
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.
Measured: 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.
Measured: Immediately post-procedure, 3, 12 and 24 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start25 Nov 2020
- Primary completion24 May 2022
- Study completion24 May 2022
Why it stopped: Funding no longer available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Haemorrhoidal BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raman Uberoi, FRCR, Principal investigator, John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Headington, Oxford OX3 9DU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684251
- Sponsor's protocol ID
- 12397
- Acronym
- ARTEMIS
- Status last verified
- Aug 2022
- First submitted
- 21 Dec 2020
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 24589187Nystrom 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.
PubMed 20035531
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARTerial EMbolization for haemorrhoIdal Disease Study
- ClinicalTrials.gov ID
- NCT04684251
- Acronym / sponsor ID
- ARTEMIS / 12397
- Conditions
- Haemorrhoidal Bleeding
- Keywords
- haemorrhoid, embolisation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding no longer available.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 24 May 2022 (actual)
- Study completion
- 24 May 2022 (actual)
- First posted
- 24 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Procedure: Coil embolisation of hemorrhoidal arteries.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. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult male and female patients between the ages of 40-90 years old.
- Patients with grade II-IV haemorrhoid disease with re-current or active bleeding AND
- Patients with (ii) who do not wish to undergo surgery for their symptoms OR
- Patients with (ii) despite previous surgery.
- Patients who can understand and sign the consent form.
Key exclusion criteria (6 listed)
- Patients who are not otherwise fit for surgery.
- Patients with significant ano-rectal comorbidities (cancer, fistula, abscesses).
- Patients who are unable to sign the inform consent form.
- Pregnancy.
- Patients with history of significant colorectal disease or previous colectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coil embolisation of hemorrhoidal arteries.Coil embolisation of hemorrhoidal arteries as previously described. | Procedure or surgery | Treatment arm |
Primary outcome
To assess the clinical success of the procedure
Time frame: Pre-operative (day of procedure) 3, 12, and 24 months post-operatively
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.
2 secondary outcomes
To assess the technical success of the procedure
Time frame: Day of procedure (immediately at time of procedure)
To assess the safety of the procedure and potential side effects
Time frame: Immediately post-procedure, 3, 12 and 24 months post-operatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Background: PubMed 24589187Vidal 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.
- Background: PubMed 20035531Nystrom 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raman Uberoi, FRCR principal investigator
John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Headington, Oxford OX3 9DU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coil embolisation of hemorrhoidal arteries. in people with Haemorrhoidal Bleeding, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the clinical success of the procedure (time frame: Pre-operative (day of procedure) 3, 12, and 24 months post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04684251, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2022.