Preemptive Endoluminal Negative Pressure in Minimally Invasive Transthoracic Esophagectomy

Esophageal Cancer Clinical Trial

Official title:

Preemptive Endoluminal Negative Pressure Therapy at the Anastomotic Site in Minimally Invasive Transthoracic Esophagectomy - An International Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04162860
• Other study ID #: 2019-00562
• Status: Recruiting
• Phase: N/A
• Start date: December 4, 2019
• Est. completion date: March 2021

Study information

• Verified date: December 2019
• Source: University of Zurich
• Contact: Christian A. Gutschow, MD
• Phone: +41442559723
• Email: christian.gutschow[@]usz.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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+)

Related Conditions & MeSH terms

• Anastomotic Leak
• Esophageal Cancer
• Leak, Anastomotic
• Surgery--Complications

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Postoperative Complications	Assessment of postoperative complications according to Clavien-Dindo	90-days postoperatively
Secondary	Postoperative Complications	Hospital readmissions	90-days postoperatively
Secondary	Postoperative Complications	Anastomotic stricture	90-days postoperatively