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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | In the control group, patients will undergo standard management. | |
| Ischemic preconditioning group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 7 post embolization (performed 3 weeks before surgical resection of the rectum) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Gender | Male/Female | Day 0, on the day of inclusion |
| Age | In years | Day 0, on the day of inclusion |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin BERTRAND, Professor | Contact | +336.43.50.35.22 | martin.bertrand@chu-nimes.fr | |
| Anissa MEGZARI | Contact | +33466684236 | drc@chu-nimes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Saint-Eloi | Recruiting | Montpellier | 34295 | France |
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Pilot exploratory descriptive prospective bicentric study to evaluate the safety and efficacy of an innovative procedure: inferior mesenteric artery embolization prior to rectal cancer surgery involving 2 groups: one with standard treatment and the other with inferior mesenteric artery embolization.
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Due to the type of intervention and the design of the study, the patient and the referring caregivers cannot be blinded.
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| 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). |
|
| Day 0, on the day of embolization |
| 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) | Post-operative Day 30 |
| 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) | Post-operative Day 30 |
| 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) | Post-operative Day 30 |
| 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) | Post-operative Day 30 |
| 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) | Post-operative Day 30 |
| 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) | Post-operative Day 30 |
| 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) | Post-operative Day 30 |
| 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). | Day 0 |
| 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). | Post-operative Day 30 |
| Duration of post-surgical hospitalization | Length of hospital stay (number of days) | Up to 30 days after rectal surgery |
| 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. | Week 3 to 4 on the day of rectal surgery |
| 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 | Day 0 (on the day of inclusion) |
| 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 | 25 minutes before embolization |
| 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 | 60 minutes after embolization |
| 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 | Week 3 to 4 after patient induction just before rectal surgery |
| Systemic inflammation markers: Complement protein C3 | Complement protein C3 will be measured as a percentage | Day 0 (on the day of inclusion) |
| Systemic inflammation markers: Complement protein C3 | Complement protein C3 will be measured as a percentage | 25 minutes before embolization |
| Systemic inflammation markers: Complement protein C3 | Complement protein C3 will be measured as a percentage | 60 minutes after embolization |
| Systemic inflammation markers: Complement protein C3 | Complement protein C3 will be measured as a percentage | Week 3 to 4 after patient induction just before rectal surgery |
| Anti-inflammation markers: | IL-10 and Transforming Growth Factor-β will be measured as percentages | Day 0 (on the day of inclusion) |
| Anti-inflammation markers: | IL-10 and Transforming Growth Factor-β will be measured as percentages | 25 minutes before embolization |
| Anti-inflammation markers: | IL-10 and Transforming Growth Factor-β will be measured as percentages | 60 minutes after embolization |
| Anti-inflammation markers: | IL-10 and Transforming Growth Factor-β will be measured as percentages | Week 3 to 4 after patient induction just before rectal surgery |
| Hemostasis markers : Von Willebrand factor | Von Willebrand factor will be measured. | Day 0 (on the day of inclusion) |
| Hemostasis markers : Von Willebrand factor | Von Willebrand factor will be measured. | 25 minutes before embolization |
| Hemostasis markers : Von Willebrand factor | Von Willebrand factor will be measured. | 60 minutes after embolization |
| Hemostasis markers : Von Willebrand factor | Von Willebrand factor will be measured. | Week 3 to 4 after patient induction just before rectal surgery |
| Hemostasis markers : coagulation factor V | Coagulation factor V will be measured. | Day 0 (on the day of inclusion) |
| Hemostasis markers : coagulation factor V | Coagulation factor V will be measured. | 25 minutes before embolization |
| Hemostasis markers : coagulation factor V | Coagulation factor V will be measured. | 60 minutes after embolization |
| Hemostasis markers : coagulation factor V | Coagulation factor V will be measured. | Week 3 to 4 after patient induction just before rectal surgery |
| Hemostasis markers : D-dimers | D-dimers will be measured | Day 0 (on the day of inclusion) |
| Hemostasis markers : D-dimers | D-dimers will be measured | 25 minutes before embolization |
| Hemostasis markers : D-dimers | D-dimers will be measured | 60 minutes after embolization |
| Hemostasis markers : D-dimers | D-dimers will be measured | Week 3 to 4 after patient induction just before rectal surgery |
| Hemostasis markers : platelet-activating factor (PAF) | Platelet-activating factor (PAF) will be measured | Day 0 (on the day of inclusion) |
| Hemostasis markers : platelet-activating factor (PAF) | Platelet-activating factor (PAF) will be measured | 25 minutes before embolization |
| Hemostasis markers : platelet-activating factor (PAF) | Platelet-activating factor (PAF) will be measured | 60 minutes after embolization |
| Hemostasis markers : platelet-activating factor (PAF) | Platelet-activating factor (PAF) will be measured | Week 3 to 4 after patient induction just before rectal surgery |
| Hemostasis markers : prostaglandin E4 | Prostaglandin E4 will be measured | Day 0 (on the day of inclusion) |
| Hemostasis markers : prostaglandin E4 | Prostaglandin E4 will be measured | 25 minutes before embolization |
| Hemostasis markers : prostaglandin E4 | Prostaglandin E4 will be measured | 60 minutes after embolization |
| Hemostasis markers : prostaglandin E4 | Prostaglandin E4 will be measured | Week 3 to 4 after patient induction just before rectal surgery |
| Hemostasis markers : Thromboxane B2 | Thromboxane B2 will be measured. | Day 0 (on the day of inclusion) |
| Hemostasis markers : Thromboxane B2 | Thromboxane B2 will be measured. | 25 minutes before embolization |
| Hemostasis markers : Thromboxane B2 | Thromboxane B2 will be measured. | 60 minutes after embolization |
| Hemostasis markers : Thromboxane B2 | Thromboxane B2 will be measured. | Week 3 to 4 after patient induction just before rectal surgery |
| Markers of tissue inflammation: Blood pH | Blood pH will be measured | Day 0 (on the day of inclusion) |
| Markers of tissue inflammation: Blood pH | Blood pH will be measured | 25 minutes before embolization |
| Markers of tissue inflammation: Blood pH | Blood pH will be measured | 60 minutes after embolization |
| Markers of tissue inflammation: Blood pH | Blood pH will be measured | Week 3 to 4 after patient induction just before rectal surgery |
| Markers of tissue inflammation: ischemia-modified albumin | Ischemia-modified albumin will be measured | Day 0 (on the day of inclusion) |
| Markers of tissue inflammation: ischemia-modified albumin | Ischemia-modified albumin will be measured | 25 minutes before embolization |
| Markers of tissue inflammation: ischemia-modified albumin | Ischemia-modified albumin will be measured | 60 minutes after embolization |
| Markers of tissue inflammation: ischemia-modified albumin | Ischemia-modified albumin will be measured | Week 3 to 4 after patient induction just before rectal surgery |
| Markers of tissue inflammation:intestinal fatty acid-binding protein (I-FABP) | intestinal fatty acid-binding protein (I-FABP) will be measured | Day 0 (on the day of inclusion) |
| Markers of tissue inflammation:intestinal fatty acid-binding protein (I-FABP) | intestinal fatty acid-binding protein (I-FABP) will be measured | 25 minutes before embolization |
| Markers of tissue inflammation:intestinal fatty acid-binding protein (I-FABP) | intestinal fatty acid-binding protein (I-FABP) will be measured | 60 minutes after embolization |
| Markers of tissue inflammation:intestinal fatty acid-binding protein (I-FABP) | intestinal fatty acid-binding protein (I-FABP) will be measured | Week 3 to 4 after patient induction just before rectal surgery |
| Markers of tissue inflammation: L-lactate | L-lactate will be measured | Day 0 (on the day of inclusion) |
| Markers of tissue inflammation: L-lactate | L-lactate will be measured | 25 minutes before embolization |
| Markers of tissue inflammation: L-lactate | L-lactate will be measured | 60 minutes after embolization |
| Markers of tissue inflammation: L-lactate | L-lactate will be measured | Week 3 to 4 after patient induction just before rectal surgery |
| Markers of tissue inflammation: D-lactate | D-lactate will be measured | Day 0 (on the day of inclusion) |
| Markers of tissue inflammation: D-lactate | D-lactate will be measured | 25 minutes before embolization |
| Markers of tissue inflammation: D-lactate | D-lactate will be measured | 60 minutes after embolization |
| Markers of tissue inflammation: D-lactate | D-lactate will be measured | Week 3 to 4 after patient induction just before rectal surgery |
| Markers of tissue inflammation: Lactate dehydrogenase | Lactate dehydrogenase will be measured | Day 0 (on the day of inclusion) |
| Markers of tissue inflammation: Lactate dehydrogenase | Lactate dehydrogenase will be measured | 25 minutes before embolization |
| Markers of tissue inflammation: Lactate dehydrogenase | Lactate dehydrogenase will be measured | 60 minutes after embolization |
| Markers of tissue inflammation: Lactate dehydrogenase | Lactate dehydrogenase will be measured | Week 3 to 4 after patient induction just before rectal surgery |
| Markers of neoangiogenesis : CD34 | CD34 will be measured | Day 0 (on the day of inclusion) |
| Markers of neoangiogenesis : CD34 | CD34 will be measured | 25 minutes before embolization |
| Markers of neoangiogenesis : CD34 | CD34 will be measured | 60 minutes after embolization |
| Markers of neoangiogenesis : CD34 | CD34 will be measured | Week 3 to 4 after patient induction just before rectal surgery |
| Markers of neoangiogenesis : transcription factor HIF1-α | Transcription factor HIF1-α will be measured | Day 0 (on the day of inclusion) |
| Markers of neoangiogenesis : transcription factor HIF1-α | Transcription factor HIF1-α will be measured | 25 minutes before embolization |
| Markers of neoangiogenesis : transcription factor HIF1-α | Transcription factor HIF1-α will be measured | 60 minutes after embolization |
| Markers of neoangiogenesis : transcription factor HIF1-α | Transcription factor HIF1-α will be measured | Week 3 to 4 after patient induction just before rectal surgery |
| 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 | Day 0 (on the day of inclusion) |
| 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 | 25 minutes before embolization |
| 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 | 60 minutes after embolization |
| 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 | Week 3 to 4 after patient induction just before rectal surgery |
| Markers of epithelial-mesenchymal transition : matrix metallo-protease - 2 | Matrix metallo-protease - 2 will be measured | Day 0 (on the day of inclusion) |
| Markers of epithelial-mesenchymal transition : matrix metallo-protease - 2 | Matrix metallo-protease - 2 will be measured | 25 minutes before embolization |
| Markers of epithelial-mesenchymal transition : matrix metallo-protease - 2 | Matrix metallo-protease - 2 will be measured | 60 minutes after embolization |
| Markers of epithelial-mesenchymal transition : matrix metallo-protease - 2 | Matrix metallo-protease - 2 will be measured | Week 3 to 4 after patient induction just before rectal surgery |
| Markers of epithelial-mesenchymal transition : matrix metallo-protease - 9 | Matrix metallo-protease - 9 will be measured | Day 0 (on the day of inclusion) |
| Markers of epithelial-mesenchymal transition : matrix metallo-protease - 9 | Matrix metallo-protease - 9 will be measured | 25 minutes before embolization |
| Markers of epithelial-mesenchymal transition : matrix metallo-protease - 9 | Matrix metallo-protease - 9 will be measured | 60 minutes after embolization |
| Markers of epithelial-mesenchymal transition : matrix metallo-protease - 9 | Matrix metallo-protease - 9 will be measured | Week 3 to 4 after patient induction just before rectal surgery |
| 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 | Day 0 (on the day of inclusion) |
| 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 | 25 minutes before embolization |
| 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 | 60 minutes after embolization |
| 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 | Week 3 to 4 after patient induction just before rectal surgery |
| Height | In centimeters | Day 0, on the day of inclusion |
| 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. | Day 0, on the day of inclusion |
| 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. | Day 0, on the day of inclusion |
| Circumferential resection margin | In millimeters | Week 3 or 4 on the day of surgery |
| Distance from the lower pole of the tumor relative to the upper edge of the anal sphincter | In millimeters | Week 3 or 4 on the day of surgery |
| Bi-ischial diameter | In millimeters | Week 3 or 4 on the day of surgery |
| Bi-uterine diameter | In millimeters | Week 3 or 4 on the day of surgery |
| Mesorectal area | In square millimeters | Week 3 or 4 on the day of surgery |
| Type of surgery |
| Week 3 or 4 on the day of surgery |
| Cardiovascular risk factors | All cardiovascular risk factors will be recorded | Day 0 on the day of inclusion |
| Presence of the border arcade, occlusion of the mesenteric artery during arteriography. | YES/NO | Day 0 on the day of inclusion |
| Operative data | Operative data: mobilisation of the colonic angle and ligation of the mesenteric vein. | Week 3 or 4 on the day of surgery |
| Institut du Cancer de Montpellier | Recruiting | Montpellier | 34298 | France |
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| CHU de Nîmes | Recruiting | Nîmes | 30029 | France |
|
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D019194 | Ischemic Preconditioning |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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