This study is a randomized clinical trial to clarify if preoperative embolization of gastric arteries can reduce the incidence of oesophagogastric leakage after an esophagectomy for esophageal cancer comparing an experimental group vs control group.
In patients with infracarinal esophageal carcinoma, the surgery is a complex procedure and with a high morbidity. It consists of a subtotal esophagectomy with tubular gastroplasty and cervical esophagogastric anastomosis. The most important complication is the anastomotic leakage with a high mortality. Among the possible causes of anastomotic leakage an important factor is the impaired microcirculation in the anastomotic region after the partial devascularization of the stomach during the surgery. There are several experimental studies about the different techniques to improve this vascularization and their effects on mucosal oxygenation. There are several methods currently used for assessing tissue oxygenation. The polarographic partial pressure of oxygen (pO2) electrode has been considered as the 'gold standard' for measuring oxygen tension. This is the reason why tissue pressure of oxygen (PtiO2) will be measured by Licox® (Integra Neuroscience) system in two groups. There aren't prospective randomized controlled trials to answer these questions. For this reason the investigators propose to perform a prospective randomized controlled trial in patients underwent on this surgery, comparing two groups: one of them will be carried out a preoperative arterial embolization (PAE), and the other one will be operated directly, to demonstrate if the ischemic conditioning by PAE can reduce the incidence of anastomotic esophagogastric leakage and improve the gastric conduit oxygenation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
40
PAE will be performed by arteriographic procedure before esophageal resection surgery minimum 14 days before surgery. An angiogram of the celiac trunk is performed through a femoral access before and after the embolization. Embolization by coils of the left gastric artery, splenic artery and the right gastric artery is realized.
Hospital Clínico Universitario de Valencia
Valencia, VAL, Spain
Anastomotic leakage
Clinic, endoscopy or computed tomography with oral contrast of dehiscence of oesophagogastric anastomosis.
Time frame: 90 days
Tissue pressure oxygen (Ptio2)
Licox oxygen monitoring system placed during the surgery in the gastric conduit. Measurements: intraoperatively and 24 hours and 48 hours after surgery.
Time frame: 48 hours
Relation between PtiO2 and anastomotic leakage
We will analyse the correlation between the measurement of tissue pressure oxygen and the prevention of anastomotic leakage.
Time frame: 90 days
Gastric Conduit ischemia
Plasty ischemia when one or more of the following criteria is present: * Endoscopic evidence of gastric mucosa ischemia * Evidence in a thoracoabdominal CT with endovenous contrast
Time frame: 90 days
Morbidity
Investigator will analyse the morbidity between the two groups with the common postoperative complications: - Anastomotic leakage * Wound infection * Pulmonary complications * Complications related to PAE * Cardiologic complications
Time frame: 90 days
Mortality
Postoperative mortality has been defined as any death, regardless of cause, occurring within 30 days after surgery in or out of the hospital.
Time frame: 90 days
Hospital Stay
investigators will consider since the day of the surgery until the day the patient will be discharged from the hospital
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Time frame: 90 days