Ischemic Conditioning of the Gastric Conduit in Esophageal Cancer.

NCT04268654 | Completed

• 1 other identifier: TIGOAL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Anastomotic Leak; Tissue Pressure of Oxygen

Outcome Measures

Primary Outcomes (1)

• Anastomotic leakage

  Clinic, endoscopy or computed tomography with oral contrast of dehiscence of oesophagogastric anastomosis.

  90 days

Secondary Outcomes (6)

• Tissue pressure oxygen (Ptio2)

  48 hours

• Relation between PtiO2 and anastomotic leakage

  90 days

• Gastric Conduit ischemia

  90 days

• Morbidity

  90 days

• Mortality

  90 days

Study Arms (2)

Ischemic Conditioning

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Preoperative Arterial Embolization 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.

Ischemic Conditioning

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Hospital Clínico Universitario de Valencia

Valencia, VAL, 46010, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 13, 2020
• Study Start: June 13, 2017
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: January 21, 2022

Record last verified: 2021-11

Locations

ES (1)