This is a randomized clinical trial to clarify if the delay phenomenon could reduce the incidence of oesophagogastric dehiscence after an esophagectomy for esophageal cancer comparing an experimental group vs control group. The delay phenomenon will be performed by an arteriographic approach.
Subtotal esophagectomy with tubular gastroplasty to upper mediastinum and esophagogastric anastomosis (Ivor-Lewis procedure) is a very complex surgical technique. It is performed in patients with infracarinal esophageal carcinoma and is associated with a high morbidity rate in specialized centers (up to 60% in some groups). One of the most important postoperative complications is the oesophagogastric anastomotic leakage which leads to high morbidity (mediastinitis, respiratory failure, pleural effusion) and mortality rate (up to 60% depending on the reports). The most important cause of anastomotic leakage is the stomach's extreme sensitivity to ischemic injury. There are several experimental studies that have demonstrated that the delay phenomenon before the esophageal resection surgery aims to improve blood perfusion after a period of time. Few studies, only case-reports, describe a decrease in the incidence of intrathoracic and cervical anastomotic leakage. May the delay phenomenon reduce the incidence of anastomotic intrathoracic leakage?. There aren't any prospective randomized controlled trials to answer this question. For this reason the investigators propose to perform a prospective randomized controlled trial in patients who underwent a subtotal esophagectomy (Ivor-Lewis procedure), comparing two groups: one of them will be submitted to a delay phenomenon by arteriographic procedure before esophageal resection surgery, and the other one will be operated on directly, to demonstrate if the delay phenomenon can reduce the incidence of anastomotic esophagogastric leakage. We decided to conduct this trial as a pilot study due to the fact that the number of patients needed to achieve statistical significance was to high and would have taken almost 10 years. We established a recruitment period of 3 years, in wich we intend to include 60 patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
44
we improve the microvascularization of the gastric fundus occluding the right and left gastric artery, and splenic artery two weeks before surgery by arteriography
Leandre Farran Teixidor
L'Hospitalet de Llobregat, Barcelona, Spain
Anastomotic leakage
investigators will consider anastomotic dehiscence the presence of one or more of the following conditions: radiologic confirmation by water-soluble contrast study (gastrografin administered orally) or thoracoabdominal Tc with oral contrast of dehiscence of oesophagogastric anastomosis or the stapler end of the gastroplasty. When the clinical conditions of patient don't allow a Rx control investigators will consider an anastomotic leakage in these conditions: Thoracic drain output of oesophagogastric content with amylase \> 40 ukAT/L, confirmation of anastomotic dehiscence by the surgeon during a reintervention, endoscopic confirmation of anastomotic leakage of the stapled end of the plasty and methylene blue output after oral administration (100 ml of water with 10ml of methylene blue)
Time frame: 7 days
plasty ischemia
investigators will consider plasty ischemia when one or more of the following criteria is present: * endoscopic evidence of gastric mucosa ischemia * evidence of low captation of the plasty in a thoracoabdominal CT with endovenous contrast that requires a reintervention. * intraoperative mortality (during hospitalization and/or 30 days after surgery).
Time frame: 7 days
hospital stay
investigators will consider since the day of the surgery until the day the patient will be discharged from the hospital
Time frame: 90 days
major and minor morbidity
investigators will evaluate morbidity according to Clavien-Dindo classification
Time frame: 90 days
postoperative mortality
Time frame: during hospitalization and/or 30 days after surgery
post-embolization morbidity
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investigators will consider post-embolization morbidity the following situations: * abdominal pain with EVA\>3 (evaluated by EVA classification ) * pancreatitis diagnosed by abdominal pain and amylase \> 5 uKat/L or by CT. * abscess, pseudocyst diagnosed by CT or during oesophageal surgery * spleen ischemia diagnosed by CT or abdominal ultrasound and needs some treatment * liver ischemia diagnosed by Ct or abdominal ultrasound * bleeding or artery dissection diagnosed during the embolization and needs some treatment * arterial pseudoaneurism diagnosed during the embolization or by CT
Time frame: 30 days
anastomotic stricture
investigators will consider anastomotic stricture when they observe a reduction of anastomotic diameter by oral contrast Rx and needs some treatment (endoscopic dilation or reintervention)
Time frame: 6 months