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NCT Number: NCT06236633

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

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.

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Key information

Conditions

Cancer, Rectal Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Saint-Eloi, Montpellier, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Ischemic preconditioning

Procedure

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).

Arteriogram

Procedure

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).

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.

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

Secondary outcomes

  1. Technical success of the embolization procedure

    Time frame: Day 0, on the day of embolization

    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

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

    Time frame: Post-operative Day 30

    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)

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

    Time frame: Post-operative Day 30

    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)

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

    Time frame: Post-operative Day 30

    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)

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

    Time frame: Post-operative Day 30

    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)

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

    Time frame: Post-operative Day 30

    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)

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

    Time frame: Post-operative Day 30

    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)

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

    Time frame: Post-operative Day 30

    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)

  9. Rate of fistulas up to 30 days after surgery

    Time frame: Day 0

    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).

  10. Rate of fistulas up to 30 days after surgery

    Time frame: Post-operative Day 30

    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).

  11. Duration of post-surgical hospitalization

    Time frame: Up to 30 days after rectal surgery

    Length of hospital stay (number of days)

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

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

  13. Systemic inflammation markers: Pro-inflammation cytokines

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

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

  14. Systemic inflammation markers: Pro-inflammation cytokines

    Time frame: 25 minutes before embolization

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

  15. Systemic inflammation markers: Pro-inflammation cytokines

    Time frame: 60 minutes after embolization

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

  16. Systemic inflammation markers: Pro-inflammation cytokines

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

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

  17. Systemic inflammation markers: Complement protein C3

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

    Complement protein C3 will be measured as a percentage

  18. Systemic inflammation markers: Complement protein C3

    Time frame: 25 minutes before embolization

    Complement protein C3 will be measured as a percentage

  19. Systemic inflammation markers: Complement protein C3

    Time frame: 60 minutes after embolization

    Complement protein C3 will be measured as a percentage

  20. Systemic inflammation markers: Complement protein C3

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

    Complement protein C3 will be measured as a percentage

  21. Anti-inflammation markers:

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

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

  22. Anti-inflammation markers:

    Time frame: 25 minutes before embolization

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

  23. Anti-inflammation markers:

    Time frame: 60 minutes after embolization

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

  24. Anti-inflammation markers:

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

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

  25. Hemostasis markers : Von Willebrand factor

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

    Von Willebrand factor will be measured.

  26. Hemostasis markers : Von Willebrand factor

    Time frame: 25 minutes before embolization

    Von Willebrand factor will be measured.

  27. Hemostasis markers : Von Willebrand factor

    Time frame: 60 minutes after embolization

    Von Willebrand factor will be measured.

  28. Hemostasis markers : Von Willebrand factor

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

    Von Willebrand factor will be measured.

  29. Hemostasis markers : coagulation factor V

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

    Coagulation factor V will be measured.

  30. Hemostasis markers : coagulation factor V

    Time frame: 25 minutes before embolization

    Coagulation factor V will be measured.

  31. Hemostasis markers : coagulation factor V

    Time frame: 60 minutes after embolization

    Coagulation factor V will be measured.

  32. Hemostasis markers : coagulation factor V

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

    Coagulation factor V will be measured.

  33. Hemostasis markers : D-dimers

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

    D-dimers will be measured

  34. Hemostasis markers : D-dimers

    Time frame: 25 minutes before embolization

    D-dimers will be measured

  35. Hemostasis markers : D-dimers

    Time frame: 60 minutes after embolization

    D-dimers will be measured

  36. Hemostasis markers : D-dimers

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

    D-dimers will be measured

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

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

    Platelet-activating factor (PAF) will be measured

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

    Time frame: 25 minutes before embolization

    Platelet-activating factor (PAF) will be measured

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

    Time frame: 60 minutes after embolization

    Platelet-activating factor (PAF) will be measured

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

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

    Platelet-activating factor (PAF) will be measured

  41. Hemostasis markers : prostaglandin E4

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

    Prostaglandin E4 will be measured

  42. Hemostasis markers : prostaglandin E4

    Time frame: 25 minutes before embolization

    Prostaglandin E4 will be measured

  43. Hemostasis markers : prostaglandin E4

    Time frame: 60 minutes after embolization

    Prostaglandin E4 will be measured

  44. Hemostasis markers : prostaglandin E4

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

    Prostaglandin E4 will be measured

  45. Hemostasis markers : Thromboxane B2

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

    Thromboxane B2 will be measured.

  46. Hemostasis markers : Thromboxane B2

    Time frame: 25 minutes before embolization

    Thromboxane B2 will be measured.

  47. Hemostasis markers : Thromboxane B2

    Time frame: 60 minutes after embolization

    Thromboxane B2 will be measured.

  48. Hemostasis markers : Thromboxane B2

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

    Thromboxane B2 will be measured.

  49. Markers of tissue inflammation: Blood pH

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

    Blood pH will be measured

  50. Markers of tissue inflammation: Blood pH

    Time frame: 25 minutes before embolization

    Blood pH will be measured

  51. Markers of tissue inflammation: Blood pH

    Time frame: 60 minutes after embolization

    Blood pH will be measured

  52. Markers of tissue inflammation: Blood pH

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

    Blood pH will be measured

  53. Markers of tissue inflammation: ischemia-modified albumin

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

    Ischemia-modified albumin will be measured

  54. Markers of tissue inflammation: ischemia-modified albumin

    Time frame: 25 minutes before embolization

    Ischemia-modified albumin will be measured

  55. Markers of tissue inflammation: ischemia-modified albumin

    Time frame: 60 minutes after embolization

    Ischemia-modified albumin will be measured

  56. Markers of tissue inflammation: ischemia-modified albumin

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

    Ischemia-modified albumin will be measured

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

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

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

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

    Time frame: 25 minutes before embolization

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

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

    Time frame: 60 minutes after embolization

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

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

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

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

  61. Markers of tissue inflammation: L-lactate

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

    L-lactate will be measured

  62. Markers of tissue inflammation: L-lactate

    Time frame: 25 minutes before embolization

    L-lactate will be measured

  63. Markers of tissue inflammation: L-lactate

    Time frame: 60 minutes after embolization

    L-lactate will be measured

  64. Markers of tissue inflammation: L-lactate

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

    L-lactate will be measured

  65. Markers of tissue inflammation: D-lactate

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

    D-lactate will be measured

  66. Markers of tissue inflammation: D-lactate

    Time frame: 25 minutes before embolization

    D-lactate will be measured

  67. Markers of tissue inflammation: D-lactate

    Time frame: 60 minutes after embolization

    D-lactate will be measured

  68. Markers of tissue inflammation: D-lactate

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

    D-lactate will be measured

  69. Markers of tissue inflammation: Lactate dehydrogenase

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

    Lactate dehydrogenase will be measured

  70. Markers of tissue inflammation: Lactate dehydrogenase

    Time frame: 25 minutes before embolization

    Lactate dehydrogenase will be measured

  71. Markers of tissue inflammation: Lactate dehydrogenase

    Time frame: 60 minutes after embolization

    Lactate dehydrogenase will be measured

  72. Markers of tissue inflammation: Lactate dehydrogenase

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

    Lactate dehydrogenase will be measured

  73. Markers of neoangiogenesis : CD34

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

    CD34 will be measured

  74. Markers of neoangiogenesis : CD34

    Time frame: 25 minutes before embolization

    CD34 will be measured

  75. Markers of neoangiogenesis : CD34

    Time frame: 60 minutes after embolization

    CD34 will be measured

  76. Markers of neoangiogenesis : CD34

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

    CD34 will be measured

  77. Markers of neoangiogenesis : transcription factor HIF1-α

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

    Transcription factor HIF1-α will be measured

  78. Markers of neoangiogenesis : transcription factor HIF1-α

    Time frame: 25 minutes before embolization

    Transcription factor HIF1-α will be measured

  79. Markers of neoangiogenesis : transcription factor HIF1-α

    Time frame: 60 minutes after embolization

    Transcription factor HIF1-α will be measured

  80. Markers of neoangiogenesis : transcription factor HIF1-α

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

    Transcription factor HIF1-α will be measured

  81. Markers of neoangiogenesis : Growth factors

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

    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

  82. Markers of neoangiogenesis : Growth factors

    Time frame: 25 minutes before embolization

    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

  83. Markers of neoangiogenesis : Growth factors

    Time frame: 60 minutes after embolization

    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

  84. Markers of neoangiogenesis : Growth factors

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

    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

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

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

    Matrix metallo-protease - 2 will be measured

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

    Time frame: 25 minutes before embolization

    Matrix metallo-protease - 2 will be measured

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

    Time frame: 60 minutes after embolization

    Matrix metallo-protease - 2 will be measured

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

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

    Matrix metallo-protease - 2 will be measured

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

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

    Matrix metallo-protease - 9 will be measured

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

    Time frame: 25 minutes before embolization

    Matrix metallo-protease - 9 will be measured

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

    Time frame: 60 minutes after embolization

    Matrix metallo-protease - 9 will be measured

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

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

    Matrix metallo-protease - 9 will be measured

  93. Markers of epithelial-mesenchymal transition : transcription factors

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

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

  94. Markers of epithelial-mesenchymal transition : transcription factors

    Time frame: 25 minutes before embolization

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

  95. Markers of epithelial-mesenchymal transition : transcription factors

    Time frame: 60 minutes after embolization

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

  96. Markers of epithelial-mesenchymal transition : transcription factors

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

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

Other outcomes

  1. Gender

    Time frame: Day 0, on the day of inclusion

    Male/Female

  2. Age

    Time frame: Day 0, on the day of inclusion

    In years

  3. Height

    Time frame: Day 0, on the day of inclusion

    In centimeters

  4. Tumor stage

    Time frame: Day 0, on the day of inclusion

    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.

  5. Tumor, Node and Metastasis staging (TNM)

    Time frame: Day 0, on the day of inclusion

    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.

  6. Circumferential resection margin

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

    In millimeters

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

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

    In millimeters

  8. Bi-ischial diameter

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

    In millimeters

  9. Bi-uterine diameter

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

    In millimeters

  10. Mesorectal area

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

    In square millimeters

  11. Type of surgery

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

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

  12. Cardiovascular risk factors

    Time frame: Day 0 on the day of inclusion

    All cardiovascular risk factors will be recorded

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

    Time frame: Day 0 on the day of inclusion

    YES/NO

  14. Operative data

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Anissa MEGZARI

CONTACT

[email protected]

+33466684236

Martin BERTRAND, Professor

CONTACT

[email protected]

+336.43.50.35.22

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Evaluation of the Safety and Efficacy of Ischemic Preconditioning by Embolization of the Inferior Mesenteric Artery in Oncologic Surgery for Tumors of the Lower and Middle Rectum. Bicentric Exploratory Pilot Study

Acronym: AMIREMBOL_2

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Feb 1, 2024
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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