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Completed

NCT Number: NCT04268654

Ischemic Conditioning of the Gastric Conduit in Esophageal Cancer.

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.

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Key information

Conditions

Esophageal Anastomotic Leak Tissue Pressure of Oxygen

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínico Universitario de Valencia

Valencia, VAL, 46010, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Anastomotic leakage

    Time frame: 90 days

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

Secondary outcomes

  1. Tissue pressure oxygen (Ptio2)

    Time frame: 48 hours

    Licox oxygen monitoring system placed during the surgery in the gastric conduit. Measurements: intraoperatively and 24 hours and 48 hours after surgery.

  2. Relation between PtiO2 and anastomotic leakage

    Time frame: 90 days

    We will analyse the correlation between the measurement of tissue pressure oxygen and the prevention of anastomotic leakage.

  3. Gastric Conduit ischemia

    Time frame: 90 days

    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

  4. Morbidity

    Time frame: 90 days

    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

  5. Mortality

    Time frame: 90 days

    Postoperative mortality has been defined as any death, regardless of cause, occurring within 30 days after surgery in or out of the hospital.

  6. Hospital Stay

    Time frame: 90 days

    investigators will consider since the day of the surgery until the day the patient will be discharged from the hospital

Sponsors and collaborators

Lead sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Feb 13, 2020
Registry last updated
Jan 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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