Clinical trial NCT04162860: Preemptive Endoluminal Negative Pressure in Minimally Invasive Transthoracic Esophagectomy
Official title: Preemptive Endoluminal Negative Pressure Therapy at the Anastomotic Site in Minimally Invasive Transthoracic Esophagectomy - An International Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Cancer
Surgery--Complications
Leak, Anastomotic
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2019-11-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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+)

Primary outcomes:
measure: Length of hospital stay until "fit-for-discharge" criteria are reached
timeFrame: 90-days postoperatively
Secondary outcomes:
measure: Postoperative Complications
timeFrame: 90-days postoperatively
measure: Postoperative Complications
timeFrame: 90-days postoperatively
measure: Postoperative Complications
timeFrame: 90-days postoperatively
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University of Zurich
name: Christian Gutschow, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.