Clinical trial NCT04268654: Ischemic Conditioning of the Gastric Conduit in Esophageal Cancer.
Official title: Trial on Ischemic Conditioning of the Gastric Conduit in Esophageal Cancer. Effects on Oxygenation and Anastomotic Leakage.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Anastomotic Leak
Tissue Pressure of Oxygen
Lead sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* All patients requiring a esophagectomy with cervical esophagogastrostomy for esophageal cancer
* 18 or above years old
* Karnofsky\>50%
* Acceptance and signing the full informed consent

Exclusion Criteria:

* Fistula tracheobronchial
* Metastatic disease
* Anatomic vascular alteration that contraindicate the embolization (congenital celiac trunk stenosis, presence of arcuate ligament, atherosclerotic stenosis, etc,..)
* Severe cardiorespiratory failure
* Refuse to collaborate in the study

Primary outcomes:
measure: Anastomotic leakage
timeFrame: 90 days
Secondary outcomes:
measure: Tissue pressure oxygen (Ptio2)
timeFrame: 48 hours
measure: Relation between PtiO2 and anastomotic leakage
timeFrame: 90 days
measure: Gastric Conduit ischemia
timeFrame: 90 days
measure: Morbidity
timeFrame: 90 days
measure: Mortality
timeFrame: 90 days
measure: Hospital Stay
timeFrame: 90 days
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
state: VAL
Study officials:
References: