Cancer, SigmoidAMIREMBOLNCT03628248
Effect of Endovascular Inferior Mesenteric Artery Embolization on Colonic Perfusion Prior to Rectal Surgery for Rectal Tumor or Sigmoid Colon Surgery
A study testing embolization of the inferior mesenteric artery and Inferior mesenteric artery ligation in people with Cancer, Sigmoid and Cancer, Rectum, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The investigators hypothesize that a primary embolization, 3-4 weeks before surgery, would allow development of vascular collaterality, in particular for the marginal artery which will ensure a better colonic perfusion. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer, Sigmoid, Cancer, Rectum
- What is being tested?
- embolization of the inferior mesenteric artery and Inferior mesenteric artery ligation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 10 Mar 2020to 11 Apr 2021
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- The patient is at least 18 years old and less than 80 years old
- Patient has rectal cancer or sigmoid colon cancer requiring surgical treatment
Who cannot join
- The subject is participating in another study, or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Patient has a history of abdominal surgery
- Patient suffers from a hemostasis disorder (hemophilia, von Willebrand disease, thrombocytopenia) and is on anticoagulant therapy.
Show all 13Show fewer
- Patient whose general condition appears too precarious or is taking corticosteroids or immunosuppressants leading to an unacceptable surgical risk.
- Renal insufficiency with clearance <45ml / min
- Known allergy to contrast media
- Patient who had treatment of the abdominal aorta or its branches Reported pregnancy (the existence of effective contraception will be verified for women of childbearing age).
- Anatomical variant at risk or absence of marginal artery highlighted at the time of arteriography.
- Abnormality of the superior mesenteric artery
- Historic occlusion of the inferior mesenteric artery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Endovascular Inferior Mesenteric Artery Embolization on Colonic Perfusion Prior to Rectal Surgery for Rectal Tumor or Sigmoid Colon Surgery - A Single-center Feasibility Pilot Study.
The investigators hypothesize that a primary embolization, 3-4 weeks before surgery, would allow development of vascular collaterality, in particular for the marginal artery which will ensure a better colonic perfusion.
- Conditions
- Cancer, Sigmoid, Cancer, Rectum
- Being tested
- embolization of the inferior mesenteric artery, Inferior mesenteric artery ligation
- Medical subject headings
- Sigmoid Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
embolization of the inferior mesenteric arteryProcedure or surgery
proximal occlusion of the inferior mesenteric artery, before its divisional branches, by coils or plug 3-4 weeks prior to surgery.
Inferior mesenteric artery ligationProcedure or surgery
Endovascular ligation of Inferior mesenteric artery
| Study group | Role | What they receive |
|---|---|---|
| embolization | Experimental | Not described Receives: Procedure: embolization of the inferior mesenteric artery; Procedure: Inferior mesenteric artery ligation |
| No embolization | Other | Not described Receives: Procedure: Inferior mesenteric artery ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen saturation of the colon after inferior mesenteric artery ligation between groups
Digital oxymeter (%)
Measured: Prior to start of surgery
Arterial pressure after inferior mesenteric artery ligation between groups
Average (mmHg)
Measured: Prior to start of surgery
Colonic perfusion in the marginal artery after inferior mesenteric artery ligation between groups
Rectal resistance index measured by Doppler
Measured: Prior to start of surgery
Oxygen saturation of the colon after inferior mesenteric artery ligation between groups
Digital oxymeter (%)
Measured: 60 seconds after surgery
Oxygen saturation of the colon after inferior mesenteric artery ligation between groups
Digital oxymeter (%)
Measured: 5 minutes after surgery
Arterial pressure in the marginal artery after inferior mesenteric artery ligation between groups
Average (mmHg)
Measured: 60 seconds after surgery
Arterial pressure in the marginal artery after inferior mesenteric artery ligation between groups
Average (mmHg)
Measured: 5 minutes after surgery
Colonic perfusion in the marginal artery after inferior mesenteric artery ligation between groups
Rectal resistance index measured by Doppler
Measured: 60 seconds after surgery
Colonic perfusion in the marginal artery after inferior mesenteric artery ligation between groups
Rectal resistance index measured by Doppler
Measured: 5 minutes after surgery
Secondary outcomes (2)
Presence of post-embolization complications
Yes/No
Measured: Day 5 post-emoblization
Presence of post-surgery complications
Yes/No
Measured: Hospital discharge (Day 7 after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start10 Mar 2020
- Primary completion11 Apr 2021
- Study completion11 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer, SigmoidStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Bertrand, MD, Principal investigator, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628248
- Sponsor's protocol ID
- NIMAO/2017-02/JF-02
- Other IDs
- 2017-A03527-46
- Acronym
- AMIREMBOL
- Status last verified
- Aug 2021
- First submitted
- 9 Aug 2018
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Frandon J, Berny L, Prudhomme M, de Forges H, Serrand C, de Oliveira F, Beregi JP, Bertrand MM. Inferior mesenteric artery embolization ahead of rectal cancer surgery: AMIREMBOL pilot study. Br J Surg. 2022 Jul 15;109(8):650-652. doi: 10.1093/bjs/znac071.
PubMed 35333313
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Endovascular Inferior Mesenteric Artery Embolization on Colonic Perfusion Prior to Rectal Surgery for Rectal Tumor or Sigmoid Colon Surgery - A Single-center Feasibility Pilot Study.
- ClinicalTrials.gov ID
- NCT03628248
- Acronym / sponsor ID
- AMIREMBOL / NIMAO/2017-02/JF-02
- Conditions
- Cancer, Sigmoid, Cancer, Rectum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 11 Apr 2021 (actual)
- Study completion
- 11 Apr 2021 (actual)
- First posted
- 14 Aug 2018 (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.
The investigators hypothesize that a primary embolization, 3-4 weeks before surgery, would allow development of vascular collaterality, in particular for the marginal artery which will ensure a better colonic perfusion.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| embolization | Experimental | Procedure: embolization of the inferior mesenteric artery, Procedure: Inferior mesenteric artery ligation |
| No embolization | Other | Procedure: Inferior mesenteric artery ligation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- The patient is at least 18 years old and less than 80 years old
- Patient has rectal cancer or sigmoid colon cancer requiring surgical treatment
Key exclusion criteria (13 listed)
- The subject is participating in another study, or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Patient has a history of abdominal surgery
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 |
|---|---|---|
| embolization of the inferior mesenteric arteryproximal occlusion of the inferior mesenteric artery, before its divisional branches, by coils or plug 3-4 weeks prior to surgery. | Procedure or surgery | embolization |
| Inferior mesenteric artery ligationEndovascular ligation of Inferior mesenteric artery | Procedure or surgery | No embolization, embolization |
Primary outcome
Oxygen saturation of the colon after inferior mesenteric artery ligation between groups
Time frame: Prior to start of surgery
Digital oxymeter (%)
Arterial pressure after inferior mesenteric artery ligation between groups
Time frame: Prior to start of surgery
Average (mmHg)
Colonic perfusion in the marginal artery after inferior mesenteric artery ligation between groups
Time frame: Prior to start of surgery
Rectal resistance index measured by Doppler
Oxygen saturation of the colon after inferior mesenteric artery ligation between groups
Time frame: 60 seconds after surgery
Digital oxymeter (%)
Oxygen saturation of the colon after inferior mesenteric artery ligation between groups
Time frame: 5 minutes after surgery
Digital oxymeter (%)
Arterial pressure in the marginal artery after inferior mesenteric artery ligation between groups
Time frame: 60 seconds after surgery
Average (mmHg)
Arterial pressure in the marginal artery after inferior mesenteric artery ligation between groups
Time frame: 5 minutes after surgery
Average (mmHg)
Colonic perfusion in the marginal artery after inferior mesenteric artery ligation between groups
Time frame: 60 seconds after surgery
Rectal resistance index measured by Doppler
Colonic perfusion in the marginal artery after inferior mesenteric artery ligation between groups
Time frame: 5 minutes after surgery
Rectal resistance index measured by Doppler
2 secondary outcomes
Presence of post-embolization complications
Time frame: Day 5 post-emoblization
Presence of post-surgery complications
Time frame: Hospital discharge (Day 7 after surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Results publication: PubMed 35333313Frandon J, Berny L, Prudhomme M, de Forges H, Serrand C, de Oliveira F, Beregi JP, Bertrand MM. Inferior mesenteric artery embolization ahead of rectal cancer surgery: AMIREMBOL pilot study. Br J Surg. 2022 Jul 15;109(8):650-652. doi: 10.1093/bjs/znac071.
Related trials for Cancer, Sigmoid
Recruiting
Comparison of Safety and Efficacy of Detaenial Sigmoid Neobladder and Ileal Neobladder
Bladder Cancer, Urinary Diversion
Recruiting
Comparison Capsule Sparing Cystectomy and Radical Cystoprostatectomy in Men With Bladder Cancer
Bladder Cancer
RecruitingObservational study
The Supraspinal Control of Lower Urinary Tract Function in Patients With Orthotopic Sigmoid Neobladder.
Orthotopic Neobladder
Enrolling by invitation
Disposable Intestinal Isolation and Protection Device for Patients With Rectal and Lower Sigmoid Colon Tumors Undergoing Laparoscopic AR/LAR Surgery
Disposable Intestinal Isolation and Protection Device
Recruiting
Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections
Colorectal Anastomosis, Left-sided Colon Resection
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.
Martin Bertrand, MD principal investigator
CHU Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing embolization of the inferior mesenteric artery and Inferior mesenteric artery ligation in people with Cancer, Sigmoid and Cancer, Rectum, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 4 inclusion and 13 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: finished, as of the sponsor's last update on 4 Dec 2025. 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 France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Oxygen saturation of the colon after inferior mesenteric artery ligation between groups (time frame: Prior to start of surgery). The study lists 9 primary outcomes in all. 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 NCT03628248, which also lists 1 linked publication.
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 4 Dec 2025.