Preemptive Endoluminal Negative Pressure in Minimally Invasive Transthoracic Esophagectomy
NCT ID: NCT04162860
Last Updated: 2019-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2019-12-04
2021-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
Eso-SPONGE® device
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.
Standard minimally invasive esophagectomy
Patients in the control group will undergo a standard minimally invasive transthoracic Ivor Lewis esophagectomy without preemptive ENP.
No interventions assigned to this group
Interventions
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Eso-SPONGE® device
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.
Eligibility Criteria
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Inclusion Criteria
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
* 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+)
18 Years
ALL
No
Sponsors
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University of Zurich
OTHER
Responsible Party
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Christian Gutschow
Professor, Head of upper gastrointestinal unit
Principal Investigators
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Christian Gutschow, MD
Role: PRINCIPAL_INVESTIGATOR
University of Zurich
Locations
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University Hospital Zurich
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Christian A. Gutschow, MD
Role: primary
References
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Muller PC, Vetter D, Kapp JR, Gubler C, Morell B, Raptis DA, Gutschow CA. Pre-Emptive Endoluminal Negative Pressure Therapy at the Anastomotic Site in Minimally Invasive Transthoracic Esophagectomy (the preSPONGE Trial): Study Protocol for a Multicenter Randomized Controlled Trial. Int J Surg Protoc. 2021 Mar 18;25(1):7-15. doi: 10.29337/ijsp.24.
Other Identifiers
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2019-00562
Identifier Type: -
Identifier Source: org_study_id