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

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Zurich

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 4, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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