Preemptive Endoluminal Negative Pressure in Minimally Invasive Transthoracic Esophagectomy

Last updated: December 10, 2019
Sponsor: University of Zurich
Overall Status: Active - Recruiting

Phase

N/A

Condition

Esophageal Cancer

Treatment

N/A

Clinical Study ID

NCT04162860
2019-00562
  • Ages > 18
  • All Genders

Study Summary

The primary objective of the preSponge randomized controlled trial (RCT) will be to assess the potential protective effects of preemptive endoscopic negative pressure therapy (ENP) on postoperative morbidity in high-risk patients undergoing total minimally invasive transthoracic esophagectomy with gastric pull-up reconstruction and high intrathoracic anastomosis (thoracoscopic and laparoscopic Ivor Lewis esophagectomy).

Eligibility Criteria

Inclusion

Inclusion Criteria: We will include adult patients (≥18 years of age) with resectable esophageal cancer (adenocarcinoma or squamous cell carcinoma) with high risk for anastomotic leakage (AL) whoprovided informed consent and are scheduled for minimally invasive transthoracic Ivor Lewisesophagectomy. Robotic-assisted procedures will also be included. Patients considered at high risk for AL must have at least one of the following riskfactors:

  • American Society of Anesthesiologists Classification (ASA) score >2

  • Diabetes (insulin dependent or HbA1c ≥ 6.5%)

  • Chronic pulmonary disease (first second of forced expiration (FEV1)/Forced volumevital capacity (FVC) ratio ≤ 70%)

  • Heart failure (left ventricular ejection fraction (LVEF) <55%)

  • Preexisting cardiac arrhythmia (pacemaker or paroxysmal supraventriculartachyarrhythmia)

  • Chronic kidney disease stage 4-5 (glomerular filtration rate (GFR) < 30ml/min/1.73 m2)

  • Chronic liver disease with treated portal hypertension (porto-caval pressure gradient ≥5-≤10mmHg, including patients with transjugular intrahepatic portosystemic shunt (TIPS))

  • Previous radiotherapy or chemo-radiation ≥50Gray (Gy) (salvage esophagectomy) Alternatively, patients must have at least two of the following risk factors:

  • Arteriosclerosis score 2 according to van Rossum et al.13 (aorta and coeliac axis)

  • Malnutrition (Body mass index (BMI) ≤ 18.5kg/m2)

  • Obesity (BMI ≥ 35kg/m2)

  • Heart failure with preserved ejection fraction (LVEF >55%)

  • Active or former smoking

  • Age > 65 years

  • World health Organisation (WHO)/Zubrodt score > 1

  • chronic kidney disease stage 2-3 (GFR 30-89 ml/min/1.73 m2)

  • chronic liver disease without portal hypertension (porto-caval pressure gradient ≤5mmHg)

Exclusion

Exclusion Criteria:

  • Inability to follow the procedures of the study, e.g. due to language problems,psychological disorders, or dementia.

  • Patients younger than 18 years

  • Patients undergoing esophagectomy for benign disease or for malignancy other thanadenocarcinoma or squamous cell carcinoma

  • Patients scheduled for other technical variants of esophagectomy, such as open,hybrid, or transhiatal procedures (intraoperative conversions to open access surgerywill not be excluded)

  • Chronic liver disease with portal hypertension (porto-caval pressure gradient >10mmHg)

  • Distant organ metastasis (cM+)

Study Design

Total Participants: 100
Study Start date:
December 04, 2019
Estimated Completion Date:
March 31, 2021

Connect with a study center

  • University Hospital Zurich

    Zürich, 8091
    Switzerland

    Active - Recruiting

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