Esophageal CancerNCT04162860
Preemptive Endoluminal Negative Pressure in Minimally Invasive Transthoracic Esophagectomy
A study testing Eso-SPONGE® device in people with Esophageal Cancer and Surgery--Complications, run by University of Zurich at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Surgery--Complications, Leak, Anastomotic
- What is being tested?
- Eso-SPONGE® device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Dec 2019to Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%)
Show all 20Show fewer
- 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)
Who cannot join
- 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+)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich, 8091
Christian A. Gutschow, MD, +41 44 255 9723, christian.gutschow@usz.ch
About this study
Official title: 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).
- Conditions
- Esophageal Cancer, Surgery--Complications, Leak, Anastomotic
- Being tested
- Eso-SPONGE® device
- Medical subject headings
- Esophageal Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eso-SPONGE® deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 90-days postoperatively
Secondary outcomes (3)
Postoperative Complications
Assessment of postoperative complications according to Clavien-Dindo
Measured: 90-days postoperatively
Postoperative Complications
Hospital readmissions
Measured: 90-days postoperatively
Postoperative Complications
Anastomotic stricture
Measured: 90-days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start4 Dec 2019
- Primary completionDec 2020 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Gutschow, University of Zurich
- Investigators
- Christian Gutschow, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162860
- Sponsor's protocol ID
- 2019-00562
- Other IDs
- 2019
- Status last verified
- Dec 2019
- First submitted
- 11 Jul 2019
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34013139
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preemptive Endoluminal Negative Pressure Therapy at the Anastomotic Site in Minimally Invasive Transthoracic Esophagectomy - An International Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04162860
- Acronym / sponsor ID
- 2019-00562
- Conditions
- Esophageal Cancer, Surgery--Complications, Leak, Anastomotic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 4 Dec 2019 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 14 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| minimally invasive esophagectomy with preemptive ENP | Experimental | Device: Eso-SPONGE® devicePatients 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. |
| Standard minimally invasive esophagectomy | No intervention | –Patients in the control group will undergo a standard minimally invasive transthoracic Ivor Lewis esophagectomy without preemptive ENP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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%)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eso-SPONGE® devicePreemptive 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. | Device | minimally invasive esophagectomy with preemptive ENP |
Primary outcome
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).
3 secondary outcomes
Postoperative Complications
Time frame: 90-days postoperatively
Postoperative Complications
Time frame: 90-days postoperatively
Postoperative Complications
Time frame: 90-days postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Derived from this study: PubMed 34013139Muller 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Gutschow, MD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eso-SPONGE® device in people with Esophageal Cancer and Surgery--Complications, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian A. Gutschow, MD (+41442559723, christian.gutschow@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay until "fit-for-discharge" criteria are reached (time frame: 90-days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04162860, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.