Ischemic Conditioning of the Gastric Conduit in Esophageal Cancer.

Trial on Ischemic Conditioning of the Gastric Conduit in Esophageal Cancer. Effects on Oxygenation and Anastomotic Leakage.

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.

Study Overview

• Status: Completed
• Conditions: Esophageal Anastomotic Leak; Tissue Pressure of Oxygen
• Intervention / Treatment: Procedure: Preoperative Arterial Embolization

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • VAL
    • Valencia, VAL, Spain, 46010
      • Hospital Clinico Universitario de Valencia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ischemic Conditioning; 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.	Procedure: Preoperative Arterial Embolization; 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.
No Intervention: Control; Surgery without previous ischemic conditioning of the gastric conduit 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anastomotic leakage	Clinic, endoscopy or computed tomography with oral contrast of dehiscence of oesophagogastric anastomosis.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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	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.	90 days
Hospital Stay	investigators will consider since the day of the surgery until the day the patient will be discharged from the hospital	90 days

Collaborators and Investigators

• Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2017
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: February 6, 2020
• First Submitted That Met QC Criteria: February 11, 2020
• First Posted (Actual): February 13, 2020

Study Record Updates

• Last Update Posted (Actual): January 21, 2022
• Last Update Submitted That Met QC Criteria: January 19, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Postoperative Complications; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Anastomotic Leak; Esophageal Neoplasms
• Other Study ID Numbers: TIGOAL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No