Preemptive Endoluminal Negative Pressure in Minimally Inv... | NCT04162860

NCT04162860

Protocol Section

Identification Module

Results Section

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Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
minimally invasive esophagectomy with preemptive ENP	Experimental	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.	Device: Eso-SPONGE® device
Standard minimally invasive esophagectomy	No Intervention	Patients in the control group will undergo a standard minimally invasive transthoracic Ivor Lewis esophagectomy without preemptive ENP.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Eso-SPONGE® device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Length of hospital stay until "fit-for-discharge" criteria are reached	The patients' oral/enteral nutritional requirements are met by oral intake of at least liquids with optional supplementary nutrition via jejunal feeding tube. The patient should have passed flatus. The patient does not require oxygen during mobilisation (short walk or climbing stairs) or at rest. Central venous catheters should be removed before discharge (unless present preoperatively). Adequate analgesia at rest and during mobilisation (pain score <4 on a scale from 0 to 10) is achieved using both oral opioid and non-opioid analgesics. All vital signs should be normal unless abnormal preoperatively. Inflammatory parameters (white cell count, C-reactive protein) should be trending down and close to normal. There should be adequate support after discharge (assistance by family, ambulatory nursing, or rehabilitation facility).	90-days postoperatively

Secondary Outcomes

Measure	Description	Time Frame
Postoperative Complications	Assessment of postoperative complications according to Clavien-Dindo	90-days postoperatively
Postoperative Complications	Hospital readmissions

Eligibility Module

Eligibility Criteria

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+)

ID	Term
D004938	Esophageal Neoplasms
D057868	Anastomotic Leak

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms