Ischemic Conditioning of the Gastric Conduit in Esophageal Cancer.

Not Applicable

Completed

• Conditions: Esophageal Anastomotic Leak; Tissue Pressure of Oxygen
• Interventions: Procedure: Preoperative Arterial Embolization

• Registration Number: NCT04268654
• Lead Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia

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.

Study Timeline

• Study Start: 2017-06-13
• Study First Submitted: 2020-02-06
• Study First Submitted QC: 2020-02-11
• Study First Posted: 2020-02-13
• Status Verified: 2021-11
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Last Update Submitted: 2022-01-19
• Last Update Posted: 2022-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ischemic Conditioning	Preoperative Arterial Embolization	Preoperative artery embolization prior to esophagectomy Tissue pressure of oxygen measurement in both arms by Licox system. The probe is inserted directly through the skin as a cervical drainage and it is fixed by Witzel technique in the gastric conduit. It is removed after the three measurements (intraoperatively, 24h and 48h after surgery) of the PtiO2 as a normal drainage.

Primary Outcome Measures

Name	Time	Method
Anastomotic leakage	90 days	Clinic, endoscopy or computed tomography with oral contrast of dehiscence of oesophagogastric anastomosis.

Secondary Outcome Measures

Name	Time	Method
Relation between PtiO2 and anastomotic leakage	90 days	We will analyse the correlation between the measurement of tissue pressure oxygen and the prevention of anastomotic leakage.
Hospital Stay	90 days	investigators will consider since the day of the surgery until the day the patient will be discharged from the hospital
Tissue pressure oxygen (Ptio2)	48 hours	Licox oxygen monitoring system placed during the surgery in the gastric conduit. Measurements: intraoperatively and 24 hours and 48 hours after surgery.
Morbidity	90 days	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
Gastric Conduit ischemia	90 days	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
Mortality	90 days	Postoperative mortality has been defined as any death, regardless of cause, occurring within 30 days after surgery in or out of the hospital.

Trial Locations

Locations (1)

Hospital Clínico Universitario de Valencia; 🇪🇸 Valencia, VAL, Spain