- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04162860
Preemptive Endoluminal Negative Pressure in Minimally Invasive Transthoracic Esophagectomy
Preemptive Endoluminal Negative Pressure Therapy at the Anastomotic Site in Minimally Invasive Transthoracic Esophagectomy - An International Multicenter Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Christian A. Gutschow, MD
- Phone Number: +41442559723
- Email: christian.gutschow@usz.ch
Study Locations
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Zürich, Switzerland, 8091
- Recruiting
- University Hospital Zurich
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Contact:
- Christian A. Gutschow, MD
- Phone Number: +41 44 255 9723
- Email: christian.gutschow@usz.ch
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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) who provided informed consent and are scheduled for minimally invasive transthoracic Ivor Lewis esophagectomy. Robotic-assisted procedures will also be included.
Patients considered at high risk for AL must have at least one of the following risk factors:
- 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 volume vital capacity (FVC) ratio ≤ 70%)
- Heart failure (left ventricular ejection fraction (LVEF) <55%)
- Preexisting cardiac arrhythmia (pacemaker or paroxysmal supraventricular tachyarrhythmia)
- 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 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 than adenocarcinoma or squamous cell carcinoma
- Patients scheduled for other technical variants of esophagectomy, such as open, hybrid, or transhiatal procedures (intraoperative conversions to open access surgery will not be excluded)
- Chronic liver disease with portal hypertension (porto-caval pressure gradient >10mmHg)
- Distant organ metastasis (cM+)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: minimally invasive esophagectomy with preemptive ENP
Patients will undergo a standard total minimally invasive transthoracic Ivor Lewis esophagectomy with preemptive ENP.
After completion of the esophago-gastric anastomosis, an Eso-SPONGE® system will be inserted via an intraoperative gastroscopy.
ENP will be carried out upon completion of the esophago-gastrostomy, but no later than 12 hours after the surgical intervention.
Postoperatively, secretions are then continuously evacuated using a suction pump generating a negative pressure between 75 and 100 mmHg.
ENP will remain for 4 days and will be monitored with clinical parameters.
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Preemptive ENP therapy will be carried out with either an Eso-SPONGE® device system (Eso-SPONGE®, B. Braun Melsungen AG, Melsungen, Germany).
Eso-SPONGE® consists of an open-pored polyurethane foam fitted to a gastric tube.
Secretions are then continuously evacuated using a suction pump generating a negative pressure between 75 and 100 mmHg.
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No Intervention: Standard minimally invasive esophagectomy
Patients in the control group will undergo a standard minimally invasive transthoracic Ivor Lewis esophagectomy without preemptive ENP.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of hospital stay until "fit-for-discharge" criteria are reached
Time Frame: 90-days postoperatively
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90-days postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative Complications
Time Frame: 90-days postoperatively
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Assessment of postoperative complications according to Clavien-Dindo
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90-days postoperatively
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Postoperative Complications
Time Frame: 90-days postoperatively
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Hospital readmissions
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90-days postoperatively
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Postoperative Complications
Time Frame: 90-days postoperatively
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Anastomotic stricture
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90-days postoperatively
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christian Gutschow, MD, University of Zurich
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-00562
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Eso-SPONGE® device
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Mayo ClinicCompleted
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