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Ischemic Conditioning of the Gastric Conduit in Esophageal Cancer.

Primary Purpose

Esophageal Anastomotic Leak, Tissue Pressure of Oxygen

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Preoperative Arterial Embolization
Sponsored by
Fundación para la Investigación del Hospital Clínico de Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Esophageal Anastomotic Leak

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Clínico Universitario de Valencia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Ischemic Conditioning

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Relation between PtiO2 and anastomotic leakage
We will analyse the correlation between the measurement of tissue pressure oxygen and the prevention of anastomotic leakage.
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
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
Mortality
Postoperative mortality has been defined as any death, regardless of cause, occurring within 30 days after surgery in or out of the hospital.
Hospital Stay
investigators will consider since the day of the surgery until the day the patient will be discharged from the hospital

Full Information

First Posted
February 6, 2020
Last Updated
January 19, 2022
Sponsor
Fundación para la Investigación del Hospital Clínico de Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT04268654
Brief Title
Ischemic Conditioning of the Gastric Conduit in Esophageal Cancer.
Official Title
Trial on Ischemic Conditioning of the Gastric Conduit in Esophageal Cancer. Effects on Oxygenation and Anastomotic Leakage.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
June 13, 2017 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación para la Investigación del Hospital Clínico de Valencia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Anastomotic Leak, Tissue Pressure of Oxygen

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ischemic Conditioning
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Preoperative Arterial Embolization
Intervention Description
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.
Primary Outcome Measure Information:
Title
Anastomotic leakage
Description
Clinic, endoscopy or computed tomography with oral contrast of dehiscence of oesophagogastric anastomosis.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Tissue pressure oxygen (Ptio2)
Description
Licox oxygen monitoring system placed during the surgery in the gastric conduit. Measurements: intraoperatively and 24 hours and 48 hours after surgery.
Time Frame
48 hours
Title
Relation between PtiO2 and anastomotic leakage
Description
We will analyse the correlation between the measurement of tissue pressure oxygen and the prevention of anastomotic leakage.
Time Frame
90 days
Title
Gastric Conduit ischemia
Description
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
Time Frame
90 days
Title
Morbidity
Description
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
Time Frame
90 days
Title
Mortality
Description
Postoperative mortality has been defined as any death, regardless of cause, occurring within 30 days after surgery in or out of the hospital.
Time Frame
90 days
Title
Hospital Stay
Description
investigators will consider since the day of the surgery until the day the patient will be discharged from the hospital
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
State/Province
VAL
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

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Ischemic Conditioning of the Gastric Conduit in Esophageal Cancer.

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