Ischemic Conditioning of the Gastric Conduit in Esophageal Cancer.

NCT ID: NCT04268654

Last Updated: 2022-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-13
• Study Completion Date: 2021-12-01

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.

Conditions

Esophageal Anastomotic Leak; Tissue Pressure of Oxygen

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Preoperative Arterial Embolization

Intervention Type: PROCEDURE

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación para la Investigación del Hospital Clínico de Valencia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Clínico Universitario de Valencia

Valencia, VAL, Spain

Countries

Spain

Other Identifiers

TIGOAL

Identifier Type: -

Identifier Source: org_study_id