Ischemic Conditioning of the Gastric Conduit in Esophageal Cancer.

Esophageal Anastomotic Leak Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04268654
• Other study ID #: TIGOAL
• Status: Completed
• Phase: N/A
• Start date: June 13, 2017
• Est. completion date: December 1, 2021

Study information

• Verified date: November 2021
• Source: Fundación para la Investigación del Hospital Clínico de Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anastomotic Leak
• Esophageal Anastomotic Leak
• Esophageal Neoplasms
• Tissue Pressure of Oxygen

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Clínico Universitario de Valencia	Valencia	VAL

Sponsors (1)

Lead Sponsor	Collaborator
Fundación para la Investigación del Hospital Clínico de Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anastomotic leakage	Clinic, endoscopy or computed tomography with oral contrast of dehiscence of oesophagogastric anastomosis.	90 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Hospital Stay	investigators will consider since the day of the surgery until the day the patient will be discharged from the hospital	90 days