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RecruitingNCT06236633AMIREMBOL_2Updated Dec 4, 2025

Safety & Efficacy of Ischemic Preconditioning by Embolization of the Inferior Mesenteric Artery in Surgery for Tumors of Lower and Middle Rectum

An interventional study of Ischemic preconditioning and Arteriogram in Cancer, Rectal, sponsored by Centre Hospitalier Universitaire de Nīmes. Recruiting at 3 sites in France. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-12-04.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2024; still recruiting 2 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

The present study will investigate the safety of inferior mesenteric artery embolization prior to rectal surgery, according to IDEAL recommendations (Lancet 2009). It aims to assess the safety of endovascular embolization of the inferior mesenteric artery prior to surgery in patients with rectal tumors, and estimate the potential benefits in terms of time to surgery and the occurrence of post-operative fistulas.The study will also assess the impact of subacute ischemia induced by IMA embolization on colonic vasculature remodeling, colonic ischemic suffering, altered hemostasis and initiation of neo-angiogenesis through blood sampling kinetics.The hypothesis is that ischemic preconditioning by inferior mesenteric artery embolization prior to rectal cancer resection surgery is safe and will result in a decrease in acute relative colon ischemia and a reduction in the rate of fistulas and post-surgical complications. Indeed, we believe that the beneficial effects of the ischemic preconditioning of IMA will be due to better blood perfusion of the colon at 3 weeks, which is apparently linked to remodeling and/or the development of collateral vascularization.

Read the detailed description

Anastomotic fistulas are the main cause of morbidity and mortality in colorectal surgery. They are responsible for septic complications, leading to increased mortality, local recurrence, repeat surgery and impaired sexual, urinary and digestive function. Fistulas are multifactorial; among the causes, colonic vascularization seems to be a major one. Ligation of the inferior mesenteric artery during rectal surgery has been shown to reduce intraoperative colonic perfusion flow. The left colon is then vascularized only by the colonic border arcade, perfused by the superior mesenteric artery. Ischemic pre-conditioning of the arterial network prior to surgery should ensure better vascularization by developing arterial collaterality and increasing perfusion flow in the colonic border arcade. In view of major advances in interventional radiology, this preconditioning could be achieved by endovascular ligation of the inferior mesenteric artery (IMA), based on the same principle as during surgery: proximal occlusion of the inferior mesenteric artery (IMA), using embolization material (plug or coils), 3 weeks before surgery, to allow the colonic border arcade to develop. We carried out a single-center pilot study (AMIREMBOL 1, NIMAO 2017; Frandon et al. 2022) to assess the feasibility of ischemic preconditioning of the colon for patients with rectal or sigmoid cancer. The study included 10 patients, randomized into two groups: the control group, with preoperative arteriography and standard management and the "embolization" group, with embolization of the IMA three weeks prior to surgery. IMA embolization was successfully performed in all 5 patients in the embolization group, with no major complications. The effect on colonic perfusion, measured by intraoperative Doppler directly on the border arch, with recording of resistance indexes (independent of measurement angle), showed a drop in resistance indexes in the control arm, after ligation of the IMA, which persisted after 5 minutes. In the "Embolization" arm, no drop in this index was reported during surgery, reflecting good development of vascular collaterality and at least relative acute ischemia of the colon after IMA ligation during surgery. Finally, in the "control" group, one anastomotic fistula was reported after surgery and required re-operation. There were no fistulas in the embolization group.

The present study (AMIREMBOL 2) will investigate the safety of IMA embolization prior to rectal surgery, according to IDEAL recommendations (Lancet 2009). Its aim is to assess the safety of endovascular embolization of the IMA prior to surgery in patients with rectal tumors, and to estimate the potential benefits in terms of time to surgery and the occurrence of post-operative fistulas.

The study will also assess the impact of subacute ischemia induced by IMA embolization on colonic vasculature remodeling, colonic ischemic suffering, altered hemostasis and initiation of neo-angiogenesis through blood sampling kinetics.

The hypothesis is that ischemic preconditioning by inferior mesenteric artery (IMA) embolization prior to rectal cancer resection surgery is safe and will result in a decrease in acute relative colon ischemia and a reduction in the rate of fistulas and post-surgical complications. The hypothesis is that the beneficial effects of the ischemic preconditioning of IMA will be due to better blood perfusion of the colon at 3 weeks, which is apparently linked to remodeling and/or the development of collateral vascularization.

02

Conditions studied

  • Cancer, Rectal

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Keywords

  • Ischemic preconditioning surgery
  • Cancer, Rectal
  • Inferior Mesenteric Artery Embolus
03

In context

Rectal Neoplasms

1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.

This study's planned enrollment of 30 is below the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with rectal cancer eligible for surgery with ligation at the origin of the inferior mesenteric artery.
  • Patients with free, informed consent.
  • Patients affiliated to or benefiting from a health insurance plan.

Exclusion criteria

Exclusion Criteria:

  • Patients with a history of colon cancer who has undergone colon resection surgery
  • Patients with occlusion of the superior mesenteric artery or stenosis of more than 50%, visible on the CT scan performed as part of conventional management during extension workup.
  • Patients with occlusion of the IMA on the extension scan.
  • Patients with a systemic disorder responsible for haemostasis (haemophilia, Willebrand's disease, thrombocytopenia) and on anticoagulant therapy.
  • Patients taking corticosteroids or immunosuppressants leading to an unacceptable surgical risk.
  • Patients with renal insufficiency with clearance \< 30mL/min.
  • Patients with an allergy to iodine.
  • Patients who has had treatment of the abdominal aorta or its branches.
  • Patients participating in an interventional study.
  • Patients in an exclusion period determined by another study.
  • Patients under court protection, guardianship or curatorship.
  • Patients unable to give consent.
  • Patients for whom it is impossible to provide informed information.
  • Pregnant or breast-feeding patients.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • No intervention
    Control group

    In the control group, patients will undergo standard management.

  • Experimental
    Ischemic preconditioning group

    In the experimental group, patients will undergo preoperative arteriography and ischemic preconditioning One blood sample will be taken before and two samples taken after embolization of the IMA. These patients will receive a phone call on Day 7 post embolization. A blood sample will also be taken at the time of surgery.

    Procedure: Ischemic preconditioning · Procedure: Arteriogram

Interventions

  • ProcedureIschemic preconditioning

    Embolization performed via a common right femoral or radial approach, depending on the patient's conformation. Minor complications such as hematoma at the puncture site are rare in less than 1% of cases, and serious complications are exceptional. Proximal occlusion of the inferior mesenteric artery, before its dividing branches, using material adapted to arterial occlusion according to anatomical findings. Proximal occlusion during embolization is evaluated by intravascular injection into the inferior mesenteric artery, and resumption of vascularization of the distal inferior mesenteric artery is controlled by the border arcade injecting into the superior mesenteric artery. In the event of a high-risk anatomical variant, or absence of a border arcade, no embolization will be performed and the patient will be excluded from the study; this will represent no more than 1-2% of patients (surgical series describing 0.83% of ischemia in connection with absence of a border arcade).

  • ProcedureArteriogram

    The interventional radiologist performs an arteriogram of the inferior and superior mesenteric arteries (IMA and SMA respectively) to check that the SMA is free of anomalies and that the IMA has a proximal trunk long enough for embolization. The radiologist also checks for the presence of a colonic border arcade. If this is absent, embolization will not be performed: the patient will be excluded from the study.This arteriogram is carried out under local anaesthetic specifically for research purposes, as follows: Common right femoral or radial approach and placement of a small introducer. Selective arteriogram of the inferior and superior mesenteric arteries to check perfusion of the border arcade.Arterial closure system or manual compression. Return to surgery or interventional radiology department. Patient discharged the same day after medical assessment (surgeon or interventional radiologist).Telephone check-up on Day1 (standard management) and Day 7 (added as part of the protocol).

06

What researchers measure

Primary outcomes

  1. Safety of endovascular inferior mesenteric artery embolisation prior to surgical resection of the rectum in patients with tumours of the lower and middle rectum.

    Percentage of patients with a complication (any grade) within 7 days after embolisation of the inferior mesenteric artery according to the classification of the International Society of Interventional Radiology assessed during the follow-up telephone consultation by the interventional radiologist. Complications will be classified as minor (Grades A and B) or Major (grades C to F). Grade A = No therapy, no consequence Grade B = Nominal therapy, no consequence. Includes overnight admission for observation only Grade C = Requires therapy, minor hospitalization (\<48 hours) Grade D = Requires major therapy. Unplanned increase in level of care. Prolonged hospitalization (\>48 hours) Grade E = Permanent adverse sequelae Grade F= Death

    Time frame: Day 7 post embolization (performed 3 weeks before surgical resection of the rectum)

Secondary outcomes

  1. Technical success of the embolization procedure

    A control arteriogram of the inferior and superior mesenteric arteries will be carried out at the end of the embolisation procedure: intravascular injection into the inferior mesenteric artery and control of the resumption of vascularisation of the distal inferior mesenteric artery by the border arcade by injecting into the superior mesenteric artery. If embolisation fails, the patient will continue the study. The number of failures will be converted into a percentage

    Time frame: Day 0, on the day of embolization

  2. Post-surgical complications up to 30 days after surgery. Clavien-Dindo Grade I

    Percentage of patients presenting a post-operative complication according to the Clavien-Dindo Classification within 30 days of rectal surgery, assessed during hospitalization and at the 1-month post-surgical consultation, according to standard management. The Clavien-Dindo classification (Dindo et al 2004, Dindo D. 2004) classifies surgical complications into 7 categories (I, II, IIIa, IIIb, IVa, IVb and V)

    Time frame: Post-operative Day 30

  3. Post-surgical complications up to 30 days after surgery. Clavien-Dindo Grade II

    Percentage of patients presenting a post-operative complication according to the Clavien-Dindo Classification within 30 days of rectal surgery, assessed during hospitalization and at the 1-month post-surgical consultation, according to standard management. The Clavien-Dindo classification (Dindo et al 2004, Dindo D. 2004) classifies surgical complications into 7 categories (I, II, IIIa, IIIb, IVa, IVb and V)

    Time frame: Post-operative Day 30

  4. Post-surgical complications up to 30 days after surgery. Clavien-Dindo Grade IIIa

    Percentage of patients presenting a post-operative complication according to the Clavien-Dindo Classification within 30 days of rectal surgery, assessed during hospitalization and at the 1-month post-surgical consultation, according to standard management. The Clavien-Dindo classification (Dindo et al 2004, Dindo D. 2004) classifies surgical complications into 7 categories (I, II, IIIa, IIIb, IVa, IVb and V)

    Time frame: Post-operative Day 30

  5. Post-surgical complications up to 30 days after surgery. Clavien-Dindo Grade IIIb

    Percentage of patients presenting a post-operative complication according to the Clavien-Dindo Classification within 30 days of rectal surgery, assessed during hospitalization and at the 1-month post-surgical consultation, according to standard management. The Clavien-Dindo classification (Dindo et al 2004, Dindo D. 2004) classifies surgical complications into 7 categories (I, II, IIIa, IIIb, IVa, IVb and V)

    Time frame: Post-operative Day 30

  6. Post-surgical complications up to 30 days after surgery. Clavien-Dindo Grade IVa

    Percentage of patients presenting a post-operative complication according to the Clavien-Dindo Classification within 30 days of rectal surgery, assessed during hospitalization and at the 1-month post-surgical consultation, according to standard management. The Clavien-Dindo classification (Dindo et al 2004, Dindo D. 2004) classifies surgical complications into 7 categories (I, II, IIIa, IIIb, IVa, IVb and V)

    Time frame: Post-operative Day 30

  7. Post-surgical complications up to 30 days after surgery. Clavien-Dindo Grade IVb

    Percentage of patients presenting a post-operative complication according to the Clavien-Dindo Classification within 30 days of rectal surgery, assessed during hospitalization and at the 1-month post-surgical consultation, according to standard management. The Clavien-Dindo classification (Dindo et al 2004, Dindo D. 2004) classifies surgical complications into 7 categories (I, II, IIIa, IIIb, IVa, IVb and V)

    Time frame: Post-operative Day 30

  8. Post-surgical complications up to 30 days after surgery. Clavien-Dindo Grade V

    Percentage of patients presenting a post-operative complication according to the Clavien-Dindo Classification within 30 days of rectal surgery, assessed during hospitalization and at the 1-month post-surgical consultation, according to standard management. The Clavien-Dindo classification (Dindo et al 2004, Dindo D. 2004) classifies surgical complications into 7 categories (I, II, IIIa, IIIb, IVa, IVb and V)

    Time frame: Post-operative Day 30

  9. Rate of fistulas up to 30 days after surgery

    Percentage of patients with a fistula within 30 days of rectal surgery, assessed during hospitalization and at the 1-month post-surgical consultation, according to standard management.A fistula will be identified either on the basis of clinical criteria (presence of pus or enteric contents in the drains, leakage of contrast medium through the anastomosis, anastomotic dehiscence during a repeat operation), or on the basis of radiological criteria (presence of an abdominal or pelvic collection in the area of the anastomosis on CT scan) if there is clinical doubt or if a CT scan is carried out for another reason (before stoma closure, for example).

    Time frame: Day 0

  10. Rate of fistulas up to 30 days after surgery

    Percentage of patients with a fistula within 30 days of rectal surgery, assessed during hospitalization and at the 1-month post-surgical consultation, according to standard management.A fistula will be identified either on the basis of clinical criteria (presence of pus or enteric contents in the drains, leakage of contrast medium through the anastomosis, anastomotic dehiscence during a repeat operation), or on the basis of radiological criteria (presence of an abdominal or pelvic collection in the area of the anastomosis on CT scan) if there is clinical doubt or if a CT scan is carried out for another reason (before stoma closure, for example).

    Time frame: Post-operative Day 30

  11. Duration of post-surgical hospitalization

    Length of hospital stay (number of days)

    Time frame: Up to 30 days after rectal surgery

  12. Degree of difficulty experienced by the visceral surgeon during surgery

    Surgeon's assessment of degree of difficulty using a 4-point Likert scale after each operation as follows : 1= Dissection of the inferior mesenteric artery was standard 2 = Dissection of the inferior mesenteric artery was more complicated than expected 3 = Dissection of the inferior mesenteric artery was much more complicated than expected; 4 = Dissection of the inferior mesenteric artery was Very difficult.

    Time frame: Week 3 to 4 on the day of rectal surgery

  13. Systemic inflammation markers: Pro-inflammation cytokines

    Pro-inflammation cytokines (IL-1β, IL-6, IL-8, Tumor Necrosis Factor-α and Interferon-ɣ) will be measured as percentages

    Time frame: Day 0 (on the day of inclusion)

  14. Systemic inflammation markers: Pro-inflammation cytokines

    Pro-inflammation cytokines (IL-1β, IL-6, IL-8, Tumor Necrosis Factor-α and Interferon-ɣ) will be measured as percentages

    Time frame: 25 minutes before embolization

  15. Systemic inflammation markers: Pro-inflammation cytokines

    Pro-inflammation cytokines (IL-1β, IL-6, IL-8, Tumor Necrosis Factor-α and Interferon-ɣ) will be measured as percentages

    Time frame: 60 minutes after embolization

  16. Systemic inflammation markers: Pro-inflammation cytokines

    Pro-inflammation cytokines (IL-1β, IL-6, IL-8, Tumor Necrosis Factor-α and Interferon-ɣ) will be measured as percentages

    Time frame: Week 3 to 4 after patient induction just before rectal surgery

  17. Systemic inflammation markers: Complement protein C3

    Complement protein C3 will be measured as a percentage

    Time frame: Day 0 (on the day of inclusion)

  18. Systemic inflammation markers: Complement protein C3

    Complement protein C3 will be measured as a percentage

    Time frame: 25 minutes before embolization

  19. Systemic inflammation markers: Complement protein C3

    Complement protein C3 will be measured as a percentage

    Time frame: 60 minutes after embolization

  20. Systemic inflammation markers: Complement protein C3

    Complement protein C3 will be measured as a percentage

    Time frame: Week 3 to 4 after patient induction just before rectal surgery

  21. Anti-inflammation markers:

    IL-10 and Transforming Growth Factor-β will be measured as percentages

    Time frame: Day 0 (on the day of inclusion)

  22. Anti-inflammation markers:

    IL-10 and Transforming Growth Factor-β will be measured as percentages

    Time frame: 25 minutes before embolization

  23. Anti-inflammation markers:

    IL-10 and Transforming Growth Factor-β will be measured as percentages

    Time frame: 60 minutes after embolization

  24. Anti-inflammation markers:

    IL-10 and Transforming Growth Factor-β will be measured as percentages

    Time frame: Week 3 to 4 after patient induction just before rectal surgery

  25. Hemostasis markers : Von Willebrand factor

    Von Willebrand factor will be measured.

    Time frame: Day 0 (on the day of inclusion)

  26. Hemostasis markers : Von Willebrand factor

    Von Willebrand factor will be measured.

    Time frame: 25 minutes before embolization

  27. Hemostasis markers : Von Willebrand factor

    Von Willebrand factor will be measured.

    Time frame: 60 minutes after embolization

  28. Hemostasis markers : Von Willebrand factor

    Von Willebrand factor will be measured.

    Time frame: Week 3 to 4 after patient induction just before rectal surgery

  29. Hemostasis markers : coagulation factor V

    Coagulation factor V will be measured.

    Time frame: Day 0 (on the day of inclusion)

  30. Hemostasis markers : coagulation factor V

    Coagulation factor V will be measured.

    Time frame: 25 minutes before embolization

  31. Hemostasis markers : coagulation factor V

    Coagulation factor V will be measured.

    Time frame: 60 minutes after embolization

  32. Hemostasis markers : coagulation factor V

    Coagulation factor V will be measured.

    Time frame: Week 3 to 4 after patient induction just before rectal surgery

  33. Hemostasis markers : D-dimers

    D-dimers will be measured

    Time frame: Day 0 (on the day of inclusion)

  34. Hemostasis markers : D-dimers

    D-dimers will be measured

    Time frame: 25 minutes before embolization

  35. Hemostasis markers : D-dimers

    D-dimers will be measured

    Time frame: 60 minutes after embolization

  36. Hemostasis markers : D-dimers

    D-dimers will be measured

    Time frame: Week 3 to 4 after patient induction just before rectal surgery

  37. Hemostasis markers : platelet-activating factor (PAF)

    Platelet-activating factor (PAF) will be measured

    Time frame: Day 0 (on the day of inclusion)

  38. Hemostasis markers : platelet-activating factor (PAF)

    Platelet-activating factor (PAF) will be measured

    Time frame: 25 minutes before embolization

  39. Hemostasis markers : platelet-activating factor (PAF)

    Platelet-activating factor (PAF) will be measured

    Time frame: 60 minutes after embolization

  40. Hemostasis markers : platelet-activating factor (PAF)

    Platelet-activating factor (PAF) will be measured

    Time frame: Week 3 to 4 after patient induction just before rectal surgery

  41. Hemostasis markers : prostaglandin E4

    Prostaglandin E4 will be measured

    Time frame: Day 0 (on the day of inclusion)

  42. Hemostasis markers : prostaglandin E4

    Prostaglandin E4 will be measured

    Time frame: 25 minutes before embolization

  43. Hemostasis markers : prostaglandin E4

    Prostaglandin E4 will be measured

    Time frame: 60 minutes after embolization

  44. Hemostasis markers : prostaglandin E4

    Prostaglandin E4 will be measured

    Time frame: Week 3 to 4 after patient induction just before rectal surgery

  45. Hemostasis markers : Thromboxane B2

    Thromboxane B2 will be measured.

    Time frame: Day 0 (on the day of inclusion)

  46. Hemostasis markers : Thromboxane B2

    Thromboxane B2 will be measured.

    Time frame: 25 minutes before embolization

  47. Hemostasis markers : Thromboxane B2

    Thromboxane B2 will be measured.

    Time frame: 60 minutes after embolization

  48. Hemostasis markers : Thromboxane B2

    Thromboxane B2 will be measured.

    Time frame: Week 3 to 4 after patient induction just before rectal surgery

  49. Markers of tissue inflammation: Blood pH

    Blood pH will be measured

    Time frame: Day 0 (on the day of inclusion)

  50. Markers of tissue inflammation: Blood pH

    Blood pH will be measured

    Time frame: 25 minutes before embolization

  51. Markers of tissue inflammation: Blood pH

    Blood pH will be measured

    Time frame: 60 minutes after embolization

  52. Markers of tissue inflammation: Blood pH

    Blood pH will be measured

    Time frame: Week 3 to 4 after patient induction just before rectal surgery

  53. Markers of tissue inflammation: ischemia-modified albumin

    Ischemia-modified albumin will be measured

    Time frame: Day 0 (on the day of inclusion)

  54. Markers of tissue inflammation: ischemia-modified albumin

    Ischemia-modified albumin will be measured

    Time frame: 25 minutes before embolization

  55. Markers of tissue inflammation: ischemia-modified albumin

    Ischemia-modified albumin will be measured

    Time frame: 60 minutes after embolization

  56. Markers of tissue inflammation: ischemia-modified albumin

    Ischemia-modified albumin will be measured

    Time frame: Week 3 to 4 after patient induction just before rectal surgery

  57. Markers of tissue inflammation:intestinal fatty acid-binding protein (I-FABP)

    intestinal fatty acid-binding protein (I-FABP) will be measured

    Time frame: Day 0 (on the day of inclusion)

  58. Markers of tissue inflammation:intestinal fatty acid-binding protein (I-FABP)

    intestinal fatty acid-binding protein (I-FABP) will be measured

    Time frame: 25 minutes before embolization

  59. Markers of tissue inflammation:intestinal fatty acid-binding protein (I-FABP)

    intestinal fatty acid-binding protein (I-FABP) will be measured

    Time frame: 60 minutes after embolization

  60. Markers of tissue inflammation:intestinal fatty acid-binding protein (I-FABP)

    intestinal fatty acid-binding protein (I-FABP) will be measured

    Time frame: Week 3 to 4 after patient induction just before rectal surgery

  61. Markers of tissue inflammation: L-lactate

    L-lactate will be measured

    Time frame: Day 0 (on the day of inclusion)

  62. Markers of tissue inflammation: L-lactate

    L-lactate will be measured

    Time frame: 25 minutes before embolization

  63. Markers of tissue inflammation: L-lactate

    L-lactate will be measured

    Time frame: 60 minutes after embolization

  64. Markers of tissue inflammation: L-lactate

    L-lactate will be measured

    Time frame: Week 3 to 4 after patient induction just before rectal surgery

  65. Markers of tissue inflammation: D-lactate

    D-lactate will be measured

    Time frame: Day 0 (on the day of inclusion)

  66. Markers of tissue inflammation: D-lactate

    D-lactate will be measured

    Time frame: 25 minutes before embolization

  67. Markers of tissue inflammation: D-lactate

    D-lactate will be measured

    Time frame: 60 minutes after embolization

  68. Markers of tissue inflammation: D-lactate

    D-lactate will be measured

    Time frame: Week 3 to 4 after patient induction just before rectal surgery

  69. Markers of tissue inflammation: Lactate dehydrogenase

    Lactate dehydrogenase will be measured

    Time frame: Day 0 (on the day of inclusion)

  70. Markers of tissue inflammation: Lactate dehydrogenase

    Lactate dehydrogenase will be measured

    Time frame: 25 minutes before embolization

  71. Markers of tissue inflammation: Lactate dehydrogenase

    Lactate dehydrogenase will be measured

    Time frame: 60 minutes after embolization

  72. Markers of tissue inflammation: Lactate dehydrogenase

    Lactate dehydrogenase will be measured

    Time frame: Week 3 to 4 after patient induction just before rectal surgery

  73. Markers of neoangiogenesis : CD34

    CD34 will be measured

    Time frame: Day 0 (on the day of inclusion)

  74. Markers of neoangiogenesis : CD34

    CD34 will be measured

    Time frame: 25 minutes before embolization

  75. Markers of neoangiogenesis : CD34

    CD34 will be measured

    Time frame: 60 minutes after embolization

  76. Markers of neoangiogenesis : CD34

    CD34 will be measured

    Time frame: Week 3 to 4 after patient induction just before rectal surgery

  77. Markers of neoangiogenesis : transcription factor HIF1-α

    Transcription factor HIF1-α will be measured

    Time frame: Day 0 (on the day of inclusion)

  78. Markers of neoangiogenesis : transcription factor HIF1-α

    Transcription factor HIF1-α will be measured

    Time frame: 25 minutes before embolization

  79. Markers of neoangiogenesis : transcription factor HIF1-α

    Transcription factor HIF1-α will be measured

    Time frame: 60 minutes after embolization

  80. Markers of neoangiogenesis : transcription factor HIF1-α

    Transcription factor HIF1-α will be measured

    Time frame: Week 3 to 4 after patient induction just before rectal surgery

  81. Markers of neoangiogenesis : Growth factors

    Growth factors and their receptors, notably vascular endothelial growth factor (VEGF) and vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor (FGF) and fibroblast growth factor receptor (FGFR) and platelet-derived growth factor (PDGF) and platelet-derived growth factor receptor (PDGFR) will be measured

    Time frame: Day 0 (on the day of inclusion)

  82. Markers of neoangiogenesis : Growth factors

    Growth factors and their receptors, notably vascular endothelial growth factor (VEGF) and vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor (FGF) and fibroblast growth factor receptor (FGFR) and platelet-derived growth factor (PDGF) and platelet-derived growth factor receptor (PDGFR) will be measured

    Time frame: 25 minutes before embolization

  83. Markers of neoangiogenesis : Growth factors

    Growth factors and their receptors, notably vascular endothelial growth factor (VEGF) and vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor (FGF) and fibroblast growth factor receptor (FGFR) and platelet-derived growth factor (PDGF) and platelet-derived growth factor receptor (PDGFR) will be measured

    Time frame: 60 minutes after embolization

  84. Markers of neoangiogenesis : Growth factors

    Growth factors and their receptors, notably vascular endothelial growth factor (VEGF) and vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor (FGF) and fibroblast growth factor receptor (FGFR) and platelet-derived growth factor (PDGF) and platelet-derived growth factor receptor (PDGFR) will be measured

    Time frame: Week 3 to 4 after patient induction just before rectal surgery

  85. Markers of epithelial-mesenchymal transition : matrix metallo-protease - 2

    Matrix metallo-protease - 2 will be measured

    Time frame: Day 0 (on the day of inclusion)

  86. Markers of epithelial-mesenchymal transition : matrix metallo-protease - 2

    Matrix metallo-protease - 2 will be measured

    Time frame: 25 minutes before embolization

  87. Markers of epithelial-mesenchymal transition : matrix metallo-protease - 2

    Matrix metallo-protease - 2 will be measured

    Time frame: 60 minutes after embolization

  88. Markers of epithelial-mesenchymal transition : matrix metallo-protease - 2

    Matrix metallo-protease - 2 will be measured

    Time frame: Week 3 to 4 after patient induction just before rectal surgery

  89. Markers of epithelial-mesenchymal transition : matrix metallo-protease - 9

    Matrix metallo-protease - 9 will be measured

    Time frame: Day 0 (on the day of inclusion)

  90. Markers of epithelial-mesenchymal transition : matrix metallo-protease - 9

    Matrix metallo-protease - 9 will be measured

    Time frame: 25 minutes before embolization

  91. Markers of epithelial-mesenchymal transition : matrix metallo-protease - 9

    Matrix metallo-protease - 9 will be measured

    Time frame: 60 minutes after embolization

  92. Markers of epithelial-mesenchymal transition : matrix metallo-protease - 9

    Matrix metallo-protease - 9 will be measured

    Time frame: Week 3 to 4 after patient induction just before rectal surgery

  93. Markers of epithelial-mesenchymal transition : transcription factors

    Transcription factors SNAI2 (SLUG), SNAI1 (SNAIL) and zinc-finger E-box binding homeobox (ZEB-1) will be measured

    Time frame: Day 0 (on the day of inclusion)

  94. Markers of epithelial-mesenchymal transition : transcription factors

    Transcription factors SNAI2 (SLUG), SNAI1 (SNAIL) and zinc-finger E-box binding homeobox (ZEB-1) will be measured

    Time frame: 25 minutes before embolization

  95. Markers of epithelial-mesenchymal transition : transcription factors

    Transcription factors SNAI2 (SLUG), SNAIL (SNAI1) and zinc-finger E-box binding homeobox (ZEB-1) will be measured

    Time frame: 60 minutes after embolization

  96. Markers of epithelial-mesenchymal transition : transcription factors

    Transcription factors SNAI2 (SLUG), SNAIL (SNAI1) and zinc-finger E-box binding homeobox (ZEB-1) will be measured

    Time frame: Week 3 to 4 after patient induction just before rectal surgery

Other outcomes

  1. Gender

    Male/Female

    Time frame: Day 0, on the day of inclusion

  2. Age

    In years

    Time frame: Day 0, on the day of inclusion

  3. Height

    In centimeters

    Time frame: Day 0, on the day of inclusion

  4. Tumor stage

    Stage 0: Cancer cells are limited to the surface of the rectal lining. Stage I: Tumor has grown below the lining and possibly into the rectal wall. Stage II: Tumor has grown into the rectal wall and might extend into tissues around the rectum. Stage III: Tumor has invaded the lymph nodes next to the rectum and some tissues outside of the rectal wall. Stage IV: Cancer has spread to distant organs, such as the liver or lungs.

    Time frame: Day 0, on the day of inclusion

  5. Tumor, Node and Metastasis staging (TNM)

    Tis:tumor in situ, only in mucosa.T1:tumor only in inner layer of bowel T2:tumor in muscle layer of the bowel wall T3:tumor in outer lining of bowel wall but not through it. T4a: tumor has gone through outer lining of bowel wall and into the peritoneum. T4b:tumor has grown through the bowel wall into nearby organs. N:cancer spread to lymph nodes? N0: no lymph nodes containing cancer cells. N1a:cancer cells in 1 nearby lymph node, N1b:cancer cells in 2 or 3 nearby lymph nodes,N1c:nearby lymph nodes do not contain cancer, but cancer cells in the tissue near the tumor. N2a:cancer cells in 4 to 6 nearby lymph nodes, N2b:cancer cells in \>7 nearby lymph nodes. M:cancer in another part of the body (metastasis)? M0:cancer not spread to other organs, M1:cancer spread to elsewhere in the body. M1a: cancer spread to 1 distant site or organ, e.g. liver, but not to peritoneum, M1b:cancer spread to \>2 distant sites, not to tissue lining the peritoneum M1c:cancer in distant organs and peritoneum.

    Time frame: Day 0, on the day of inclusion

  6. Circumferential resection margin

    In millimeters

    Time frame: Week 3 or 4 on the day of surgery

  7. Distance from the lower pole of the tumor relative to the upper edge of the anal sphincter

    In millimeters

    Time frame: Week 3 or 4 on the day of surgery

  8. Bi-ischial diameter

    In millimeters

    Time frame: Week 3 or 4 on the day of surgery

  9. Bi-uterine diameter

    In millimeters

    Time frame: Week 3 or 4 on the day of surgery

  10. Mesorectal area

    In square millimeters

    Time frame: Week 3 or 4 on the day of surgery

  11. Type of surgery

    * Colorectal or anal anastomosis * Mechanical or manual surgery * Intersphincteric dissection Yes/ No, partial or total * Delayed colo-anal anastomosis.

    Time frame: Week 3 or 4 on the day of surgery

  12. Cardiovascular risk factors

    All cardiovascular risk factors will be recorded

    Time frame: Day 0 on the day of inclusion

  13. Presence of the border arcade, occlusion of the mesenteric artery during arteriography.

    YES/NO

    Time frame: Day 0 on the day of inclusion

  14. Operative data

    Operative data: mobilisation of the colonic angle and ligation of the mesenteric vein.

    Time frame: Week 3 or 4 on the day of surgery

07

Study locations

3 of 3 sites recruiting
  • Hôpital Saint-Eloi
    Montpellier, 34295, France
    • Boris GUIU, Pr · Contact
    • Boris GUIU, Pr · Principal investigator
    Recruiting
  • Institut du Cancer de Montpellier
    Montpellier, 34298, France
    • Philippe ROUANET, Pr · Contact
    • Philippe ROUANET, Pr · Principal investigator
    Recruiting
  • CHU de Nîmes
    Nîmes, 30029, France
    • Martin BERTRAND, Pr · Contact
    • Martin BERTRAND, Pr · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06236633
Lead sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible party
Sponsor
First posted
Feb 1, 2024
Start date
Aug 2, 2024
Primary completion
Aug 1, 2026 (estimated)
Completion
Aug 1, 2027 (estimated)
Last update
Dec 4, 2025

Study contacts

Martin BERTRAND, Professor
Contact
martin.bertrand@chu-nimes.fr
+336.43.50.35.22
Anissa MEGZARI
Contact
drc@chu-nimes.fr
+33466684236

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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