Preemptive Endoluminal Negative Pressure in Minimally Invasive Transthoracic Esophagectomy

December 10, 2019 updated by: Christian Gutschow, University of Zurich

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

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).

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.
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.
No Intervention: Standard minimally invasive esophagectomy
Patients in the control group will undergo a standard minimally invasive transthoracic Ivor Lewis esophagectomy without preemptive ENP.

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
  • 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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Christian Gutschow, MD, University of Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2019

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

July 11, 2019

First Submitted That Met QC Criteria

November 11, 2019

First Posted (Actual)

November 14, 2019

Study Record Updates

Last Update Posted (Actual)

December 13, 2019

Last Update Submitted That Met QC Criteria

December 10, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 2019-00562

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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