Cancer, Rectal Clinical Trial
— AMIREMBOL_2Official 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
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.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | February 1, 2026 |
Est. primary completion date | October 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - Patients with cancer of the lower or middle rectum, eligible for surgical treatment requiring 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 history of abdominal 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Centre Hospitalier Universitaire de Nimes |
Type | Measure | Description | Time frame | Safety issue |
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Other | Gender | Male/Female | Day 0, on the day of inclusion | |
Other | Age | In years | Day 0, on the day of inclusion | |
Other | Height | In centimeters | Day 0, on the day of inclusion | |
Other | 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 | |
Other | 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 | |
Other | Circumferential resection margin | In millimeters | Week 3 or 4 on the day of surgery | |
Other | 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 | |
Other | Bi-ischial diameter | In millimeters | Week 3 or 4 on the day of surgery | |
Other | Bi-uterine diameter | In millimeters | Week 3 or 4 on the day of surgery | |
Other | Mesorectal area | In square millimeters | Week 3 or 4 on the day of surgery | |
Other | Type of surgery | Colorectal or anal anastomosis
Mechanical or manual surgery Intersphincteric dissection Yes/ No, partial or total Delayed colo-anal anastomosis. |
Week 3 or 4 on the day of surgery | |
Other | Cardiovascular risk factors | All cardiovascular risk factors will be recorded | Day 0 on the day of inclusion | |
Other | Presence of the border arcade, occlusion of the mesenteric artery during arteriography. | YES/NO | Day 0 on the day of inclusion | |
Other | Operative data | Operative data: mobilisation of the colonic angle and ligation of the mesenteric vein. | Week 3 or 4 on the day of surgery | |
Primary | 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) | |
Secondary | 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 |
Day 0, on the day of embolization | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Duration of post-surgical hospitalization | Length of hospital stay (number of days) | Up to 30 days after rectal surgery | |
Secondary | 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 | |
Secondary | Systemic inflammation markers: Pro-inflammation cytokines | Pro-inflammation cytokines (IL-1ß, IL-6, IL-8, Tumor Necrosis Factor-a and Interferon-?) will be measured as percentages | Day 0 (on the day of inclusion) | |
Secondary | Systemic inflammation markers: Pro-inflammation cytokines | Pro-inflammation cytokines (IL-1ß, IL-6, IL-8, Tumor Necrosis Factor-a and Interferon-?) will be measured as percentages | 25 minutes before embolization | |
Secondary | Systemic inflammation markers: Pro-inflammation cytokines | Pro-inflammation cytokines (IL-1ß, IL-6, IL-8, Tumor Necrosis Factor-a and Interferon-?) will be measured as percentages | 60 minutes after embolization | |
Secondary | Systemic inflammation markers: Pro-inflammation cytokines | Pro-inflammation cytokines (IL-1ß, IL-6, IL-8, Tumor Necrosis Factor-a and Interferon-?) will be measured as percentages | Week 3 to 4 after patient induction just before rectal surgery | |
Secondary | Systemic inflammation markers: Complement protein C3 | Complement protein C3 will be measured as a percentage | Day 0 (on the day of inclusion) | |
Secondary | Systemic inflammation markers: Complement protein C3 | Complement protein C3 will be measured as a percentage | 25 minutes before embolization | |
Secondary | Systemic inflammation markers: Complement protein C3 | Complement protein C3 will be measured as a percentage | 60 minutes after embolization | |
Secondary | 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 | |
Secondary | Anti-inflammation markers: | IL-10 and Transforming Growth Factor-ß will be measured as percentages | Day 0 (on the day of inclusion) | |
Secondary | Anti-inflammation markers: | IL-10 and Transforming Growth Factor-ß will be measured as percentages | 25 minutes before embolization | |
Secondary | Anti-inflammation markers: | IL-10 and Transforming Growth Factor-ß will be measured as percentages | 60 minutes after embolization | |
Secondary | Anti-inflammation markers: | IL-10 and Transforming Growth Factor-ß will be measured as percentages | Week 3 to 4 after patient induction just before rectal surgery | |
Secondary | Hemostasis markers : Von Willebrand factor | Von Willebrand factor will be measured. | Day 0 (on the day of inclusion) | |
Secondary | Hemostasis markers : Von Willebrand factor | Von Willebrand factor will be measured. | 25 minutes before embolization | |
Secondary | Hemostasis markers : Von Willebrand factor | Von Willebrand factor will be measured. | 60 minutes after embolization | |
Secondary | Hemostasis markers : Von Willebrand factor | Von Willebrand factor will be measured. | Week 3 to 4 after patient induction just before rectal surgery | |
Secondary | Hemostasis markers : coagulation factor V | Coagulation factor V will be measured. | Day 0 (on the day of inclusion) | |
Secondary | Hemostasis markers : coagulation factor V | Coagulation factor V will be measured. | 25 minutes before embolization | |
Secondary | Hemostasis markers : coagulation factor V | Coagulation factor V will be measured. | 60 minutes after embolization | |
Secondary | Hemostasis markers : coagulation factor V | Coagulation factor V will be measured. | Week 3 to 4 after patient induction just before rectal surgery | |
Secondary | Hemostasis markers : D-dimers | D-dimers will be measured | Day 0 (on the day of inclusion) | |
Secondary | Hemostasis markers : D-dimers | D-dimers will be measured | 25 minutes before embolization | |
Secondary | Hemostasis markers : D-dimers | D-dimers will be measured | 60 minutes after embolization | |
Secondary | Hemostasis markers : D-dimers | D-dimers will be measured | Week 3 to 4 after patient induction just before rectal surgery | |
Secondary | Hemostasis markers : platelet-activating factor (PAF) | Platelet-activating factor (PAF) will be measured | Day 0 (on the day of inclusion) | |
Secondary | Hemostasis markers : platelet-activating factor (PAF) | Platelet-activating factor (PAF) will be measured | 25 minutes before embolization | |
Secondary | Hemostasis markers : platelet-activating factor (PAF) | Platelet-activating factor (PAF) will be measured | 60 minutes after embolization | |
Secondary | Hemostasis markers : platelet-activating factor (PAF) | Platelet-activating factor (PAF) will be measured | Week 3 to 4 after patient induction just before rectal surgery | |
Secondary | Hemostasis markers : prostaglandin E4 | Prostaglandin E4 will be measured | Day 0 (on the day of inclusion) | |
Secondary | Hemostasis markers : prostaglandin E4 | Prostaglandin E4 will be measured | 25 minutes before embolization | |
Secondary | Hemostasis markers : prostaglandin E4 | Prostaglandin E4 will be measured | 60 minutes after embolization | |
Secondary | Hemostasis markers : prostaglandin E4 | Prostaglandin E4 will be measured | Week 3 to 4 after patient induction just before rectal surgery | |
Secondary | Hemostasis markers : Thromboxane B2 | Thromboxane B2 will be measured. | Day 0 (on the day of inclusion) | |
Secondary | Hemostasis markers : Thromboxane B2 | Thromboxane B2 will be measured. | 25 minutes before embolization | |
Secondary | Hemostasis markers : Thromboxane B2 | Thromboxane B2 will be measured. | 60 minutes after embolization | |
Secondary | Hemostasis markers : Thromboxane B2 | Thromboxane B2 will be measured. | Week 3 to 4 after patient induction just before rectal surgery | |
Secondary | Markers of tissue inflammation: Blood pH | Blood pH will be measured | Day 0 (on the day of inclusion) | |
Secondary | Markers of tissue inflammation: Blood pH | Blood pH will be measured | 25 minutes before embolization | |
Secondary | Markers of tissue inflammation: Blood pH | Blood pH will be measured | 60 minutes after embolization | |
Secondary | Markers of tissue inflammation: Blood pH | Blood pH will be measured | Week 3 to 4 after patient induction just before rectal surgery | |
Secondary | Markers of tissue inflammation: ischemia-modified albumin | Ischemia-modified albumin will be measured | Day 0 (on the day of inclusion) | |
Secondary | Markers of tissue inflammation: ischemia-modified albumin | Ischemia-modified albumin will be measured | 25 minutes before embolization | |
Secondary | Markers of tissue inflammation: ischemia-modified albumin | Ischemia-modified albumin will be measured | 60 minutes after embolization | |
Secondary | Markers of tissue inflammation: ischemia-modified albumin | Ischemia-modified albumin will be measured | Week 3 to 4 after patient induction just before rectal surgery | |
Secondary | 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) | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Markers of tissue inflammation: L-lactate | L-lactate will be measured | Day 0 (on the day of inclusion) | |
Secondary | Markers of tissue inflammation: L-lactate | L-lactate will be measured | 25 minutes before embolization | |
Secondary | Markers of tissue inflammation: L-lactate | L-lactate will be measured | 60 minutes after embolization | |
Secondary | Markers of tissue inflammation: L-lactate | L-lactate will be measured | Week 3 to 4 after patient induction just before rectal surgery | |
Secondary | Markers of tissue inflammation: D-lactate | D-lactate will be measured | Day 0 (on the day of inclusion) | |
Secondary | Markers of tissue inflammation: D-lactate | D-lactate will be measured | 25 minutes before embolization | |
Secondary | Markers of tissue inflammation: D-lactate | D-lactate will be measured | 60 minutes after embolization | |
Secondary | Markers of tissue inflammation: D-lactate | D-lactate will be measured | Week 3 to 4 after patient induction just before rectal surgery | |
Secondary | Markers of tissue inflammation: Lactate dehydrogenase | Lactate dehydrogenase will be measured | Day 0 (on the day of inclusion) | |
Secondary | Markers of tissue inflammation: Lactate dehydrogenase | Lactate dehydrogenase will be measured | 25 minutes before embolization | |
Secondary | Markers of tissue inflammation: Lactate dehydrogenase | Lactate dehydrogenase will be measured | 60 minutes after embolization | |
Secondary | Markers of tissue inflammation: Lactate dehydrogenase | Lactate dehydrogenase will be measured | Week 3 to 4 after patient induction just before rectal surgery | |
Secondary | Markers of neoangiogenesis : CD34 | CD34 will be measured | Day 0 (on the day of inclusion) | |
Secondary | Markers of neoangiogenesis : CD34 | CD34 will be measured | 25 minutes before embolization | |
Secondary | Markers of neoangiogenesis : CD34 | CD34 will be measured | 60 minutes after embolization | |
Secondary | Markers of neoangiogenesis : CD34 | CD34 will be measured | Week 3 to 4 after patient induction just before rectal surgery | |
Secondary | Markers of neoangiogenesis : transcription factor HIF1-a | Transcription factor HIF1-a will be measured | Day 0 (on the day of inclusion) | |
Secondary | Markers of neoangiogenesis : transcription factor HIF1-a | Transcription factor HIF1-a will be measured | 25 minutes before embolization | |
Secondary | Markers of neoangiogenesis : transcription factor HIF1-a | Transcription factor HIF1-a will be measured | 60 minutes after embolization | |
Secondary | Markers of neoangiogenesis : transcription factor HIF1-a | Transcription factor HIF1-a will be measured | Week 3 to 4 after patient induction just before rectal surgery | |
Secondary | 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) | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Markers of epithelial-mesenchymal transition : matrix metallo-protease - 2 | Matrix metallo-protease - 2 will be measured | Day 0 (on the day of inclusion) | |
Secondary | Markers of epithelial-mesenchymal transition : matrix metallo-protease - 2 | Matrix metallo-protease - 2 will be measured | 25 minutes before embolization | |
Secondary | Markers of epithelial-mesenchymal transition : matrix metallo-protease - 2 | Matrix metallo-protease - 2 will be measured | 60 minutes after embolization | |
Secondary | 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 | |
Secondary | Markers of epithelial-mesenchymal transition : matrix metallo-protease - 9 | Matrix metallo-protease - 9 will be measured | Day 0 (on the day of inclusion) | |
Secondary | Markers of epithelial-mesenchymal transition : matrix metallo-protease - 9 | Matrix metallo-protease - 9 will be measured | 25 minutes before embolization | |
Secondary | Markers of epithelial-mesenchymal transition : matrix metallo-protease - 9 | Matrix metallo-protease - 9 will be measured | 60 minutes after embolization | |
Secondary | 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 | |
Secondary | 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) | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
Status | Clinical Trial | Phase | |
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Terminated |
NCT04139967 -
Study of Short Course Radiation Therapy for Elderly Patients With Rectal Cancer
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N/A |