Esophageal CancerESPYNCT06097078
Endoluminal Vacuum Therapy to Prevent Anastomotic Leakage After Esophagectomy Due to Esophageal Cancer
An observational study of Esophageal Cancer and Esophagus Cancer, run by Aesculap AG at 1 site in Spain.
Trial summary
A prospective, multi-centre, exploratory and observational one-arm study to evaluate preventive Endoluminal Vacuum Therapy(pEVT) to prevent anastomotic leakage after esophagectomy due to esophageal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Esophagus Cancer, Anastomotic Leak
- What is being tested?
- Eso-SPONGE®
- Type of treatment
- Medical device
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- 7 Oct 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients undergoing a total minimally invasive (laparoscopic or robotic and thoracoscopic) transthoracic Ivor Lewis esophagectomy (ttMILE) due to esophageal cancer and subsequent eso-SPONGE® application to prevent anastomotic leakage (AL)
Who may be able to join
- Age ≥ 18 years
- Scheduled for total minimally invasive (laparoscopic or robotic and thoracoscopic) transthoracic Ivor Lewis esophagectomy (ttMILE) due to esophageal cancer and subsequent eso-SPONGE application to prevent anastomotic leakage
- Patients able to read and understand the Patient Information Sheet and sign, if accepted, the Informed Consent Form
- Patients able, at the discretion of the investigator, to comply with the requirements of the study and without impediments to follow the instructions and assessments throughout the study.
Who cannot join
- Patients undergoing transhiatal esophagectomy without reconstruction, open Ivor Lewis esophagectomy or other esophageal resections different to ttMILE.
- Multi-organ resection during the esophagectomy.
- Emergent-urgent esophagectomy.
- Coloplasty or small bowel plasty.
- Necrotic tissue/gangrene.
- Blood clotting disorder.
Show all 11Show fewer
- Bleeding esophageal varices.
- Sponge placement required directly on major vessels.
- Patients with known sensitivities or allergies to its components
- Participation in any other clinical trial and use of any drug or experimental device, currently or in the 4 weeks prior to inclusion in the study.
- Women who are pregnant, suspected of being pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Multi-centre, Exploratory and Observational One-arm Study to Evaluate Preemptive Endoluminal Vacuum Therapy to Prevent Anastomotic Leakage After Esophagectomy Due to Esophageal Cancer
A prospective, multi-centre, exploratory and observational one-arm study to evaluate preventive Endoluminal Vacuum Therapy(pEVT) to prevent anastomotic leakage after esophagectomy due to esophageal cancer. The main objective is to evaluate the potential protective effect of prophylactic preemptive endoluminal vacuum therapy on esophageal-gastric anastomosis dehiscence after esophagectomy.
Read the detailed description
Prospective, multi-centre, exploratory and observational one-arm study to evaluate preemptive endoluminal vacuum therapy to prevent anastomotic leakage after esophagectomy due to esophageal cancer.
The study comprises a maximum of 5 visits per protocol. At visit 0, informed consent will be obtained, and the patient will be checked for compliance with all inclusion criteria and no exclusion criteria in the study. Demographic characteristics, medical history and oncological parameters will be collected. At visit 1 ttMILE will be carry out and immediately (0-24h) after completion of the anastomosis, in patients who meet selection criteria, the Eso-SPONGE® will be placed endoscopically via an overtube, as usual clinical practice of the centre. The tube will be routed transnasally and then connected to a vacuum pump, generating a continuous negative pressure of 75 mmHg. The Eso-SPONGE system will be checked 6-hourly for leakage and dislocation. The sponge will be removed after 4-6 days (V2). After removal, the anastomosis and the gastric tube will be assessed endoscopically to exclude leakage and evaluate ischemia and stenosis, and the pylorus will be evaluated for spasm. The next visits (V3 and V4) will be carried out at 30 and 90 days after the intervention has been placed. Leakage, ischemia and stenosis will be clinically evaluated at each visit and a new endoscopy will be performed in patient who show symptoms.
- Conditions
- Esophageal Cancer, Esophagus Cancer, Anastomotic Leak
- Being tested
- Eso-SPONGE®
- Keywords
- endoluminal vacuum therapy, anastomotic leakage, esophagectomy, esophageal cancer, abdominal and cardiac surgery
- 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®Device
Also called endoluminal vacuum therapy (EVT) device
minimally invasive treatment and prevention of anastomotic leakages and perforations in the upper gastrointestinal tract (upper GIT)
| Study group | Role | What they receive |
|---|---|---|
| Eso-SPONGE® | endoluminal vacuum therapy to prevent anastomotic leakage after esophagectomy due to esophageal cancer Receives: Device: Eso-SPONGE® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with anastomotic leakage
Anastomotic leakage (AL) is a severe complication following gastric and esophageal surgery. Anastomotic leakage occurs in 5-30% of patients after esophagectomy and may be further complicated by mediastinitis, sepsis, multiple organ failure, or death. The primary objective of the study is to evaluate the potential protective effect of prophylactic preemptive endoluminal vacuum therapy on esophageal-gastric anastomosis dehiscence after esophagectomy.
Measured: throughout the duration of the study (until last follow-up at postoperative day 90)
Secondary outcomes (10)
Comprehensive Complication Index
The Comprehensive Complication Index (CCI®) calculates the overall morbidity of a patient after any surgical intervention based on the complication grading by the "Clavien-Dindo Classification" (CDC). The Comprehensive Complication Index (CCI®) reflects the gravity of this overall complication burden on the patient on a scale from 0 (no complication) to 100 (death).
Measured: Postoperative day 30 and day 90
Description of Adverse Events
All the Adverse Events reported during the study will be described together with their characteristics, noting those related with the investigational device application.
Measured: throughout the duration of the study (until last follow-up at postoperative day 90)
Rate of postoperative ischemia
The different grades of postoperative ischemia at Visit 1, Visit 2 and Visit 3
Measured: Postoperative day 30 and day 90
Rate of postoperative mortality
The percentage of patients who died along the study will be described in terms of absolute and relative frequencies, as well as causes for death and time until death regarding investigational device application.
Measured: Postoperative day 30 and day 90
Rate of postoperative stenosis
The percentage of postoperative stenosis at Visit 1, Visit 2 and Visit 3, as well as along the study
Measured: throughout the duration of the study (until last follow-up at postoperative day 90)
Length of hospitalization
time elapsed until reaching the "fit for discharge criteria" regarding investigational device application
Measured: until discharge (approximately 10 days postoperatively)
Re-admissions to hospital
The percentage of patients re-admitted along the study will be described; as well as the time elapsed until re-admission regarding investigational device application
Measured: throughout the duration of the study (until last follow-up at postoperative day 90)
Surgical reoperations
The percentage of patients with surgical reoperations along the study will be described; as well as the time elapsed until surgical reoperation regarding investigational device application
Measured: throughout the duration of the study (until last follow-up at postoperative day 90)
Anastomotic leakage free survival
Event free survival at 30 days and at 90 days will be analyzed using Kaplan-Meier method, considering the anastomotic leakage reported during the study. Patients with no anastomotic leakage during the analyzed period will be censored at last follow-up date
Measured: throughout the duration of the study (until last follow-up at postoperative day 90)
Rate of intraluminal hemorrhage
The percentage of patients with intraluminal hemorrhage along the study will be described in terms of absolute and relative frequencies; as well as the time elapsed until hemorrhage regarding investigational device application. Additionally, to see the distribution of the time until intraluminal hemorrhage Kaplan-Meier method will be performed at 90 days (patients with no intraluminal hemorrhage during the study will be censored at last follow-up date).
Measured: throughout the duration of the study (until last follow-up at postoperative day 90)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start7 Oct 2024
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Aesculap AGThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Responsible party
- Sponsor
- Investigators
- Dulce Momblán García, Dr., Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097078
- Sponsor's protocol ID
- AAG-O-H-2209
- Acronym
- ESPY
- Status last verified
- Sep 2026
- First submitted
- 16 Oct 2023
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-centre, Exploratory and Observational One-arm Study to Evaluate Preemptive Endoluminal Vacuum Therapy to Prevent Anastomotic Leakage After Esophagectomy Due to Esophageal Cancer
- ClinicalTrials.gov ID
- NCT06097078
- Acronym / sponsor ID
- ESPY / AAG-O-H-2209
- Conditions
- Esophageal Cancer, Esophagus Cancer, Anastomotic Leak
- Keywords
- endoluminal vacuum therapy, anastomotic leakage, esophagectomy, esophageal cancer, abdominal and cardiac surgery
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Oct 2023 (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.
A prospective, multi-centre, exploratory and observational one-arm study to evaluate preventive Endoluminal Vacuum Therapy(pEVT) to prevent anastomotic leakage after esophagectomy due to esophageal cancer. The main objective is to evaluate the potential protective effect of prophylactic preemptive endoluminal vacuum therapy on esophageal-gastric anastomosis dehiscence after esophagectomy.
Detailed description
Prospective, multi-centre, exploratory and observational one-arm study to evaluate preemptive endoluminal vacuum therapy to prevent anastomotic leakage after esophagectomy due to esophageal cancer.
The study comprises a maximum of 5 visits per protocol. At visit 0, informed consent will be obtained, and the patient will be checked for compliance with all inclusion criteria and no exclusion criteria in the study. Demographic characteristics, medical history and oncological parameters will be collected. At visit 1 ttMILE will be carry out and immediately (0-24h) after completion of the anastomosis, in patients who meet selection criteria, the Eso-SPONGE® will be placed endoscopically via an overtube, as usual clinical practice of the centre. The tube will be routed transnasally and then connected to a vacuum pump, generating a continuous negative pressure of 75 mmHg. The Eso-SPONGE system will be checked 6-hourly for leakage and dislocation. The sponge will be removed after 4-6 days (V2). After removal, the anastomosis and the gastric tube will be assessed endoscopically to exclude leakage and evaluate ischemia and stenosis, and the pylorus will be evaluated for spasm. The next visits (V3 and V4) will be carried out at 30 and 90 days after the intervention has been placed. Leakage, ischemia and stenosis will be clinically evaluated at each visit and a new endoscopy will be performed in patient who show symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eso-SPONGE® | – | Device: Eso-SPONGE®endoluminal vacuum therapy to prevent anastomotic leakage after esophagectomy due to esophageal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing a total minimally invasive (laparoscopic or robotic and thoracoscopic) transthoracic Ivor Lewis esophagectomy (ttMILE) due to esophageal cancer and subsequent eso-SPONGE® application to prevent anastomotic leakage (AL)
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Scheduled for total minimally invasive (laparoscopic or robotic and thoracoscopic) transthoracic Ivor Lewis esophagectomy (ttMILE) due to esophageal cancer and subsequent eso-SPONGE application to prevent anastomotic leakage
- Patients able to read and understand the Patient Information Sheet and sign, if accepted, the Informed Consent Form
- Patients able, at the discretion of the investigator, to comply with the requirements of the study and without impediments to follow the instructions and assessments throughout the study.
Key exclusion criteria (11 listed)
- Patients undergoing transhiatal esophagectomy without reconstruction, open Ivor Lewis esophagectomy or other esophageal resections different to ttMILE.
- Multi-organ resection during the esophagectomy.
- Emergent-urgent esophagectomy.
- Coloplasty or small bowel plasty.
- Necrotic tissue/gangrene.
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®Also: endoluminal vacuum therapy (EVT) deviceminimally invasive treatment and prevention of anastomotic leakages and perforations in the upper gastrointestinal tract (upper GIT) | Device | Eso-SPONGE® |
Primary outcome
Rate of patients with anastomotic leakage
Time frame: throughout the duration of the study (until last follow-up at postoperative day 90)
Anastomotic leakage (AL) is a severe complication following gastric and esophageal surgery. Anastomotic leakage occurs in 5-30% of patients after esophagectomy and may be further complicated by mediastinitis, sepsis, multiple organ failure, or death. The primary objective of the study is to evaluate the potential protective effect of prophylactic preemptive endoluminal vacuum therapy on esophageal-gastric anastomosis dehiscence after esophagectomy.
10 secondary outcomes
Comprehensive Complication Index
Time frame: Postoperative day 30 and day 90
Description of Adverse Events
Time frame: throughout the duration of the study (until last follow-up at postoperative day 90)
Rate of postoperative ischemia
Time frame: Postoperative day 30 and day 90
Rate of postoperative mortality
Time frame: Postoperative day 30 and day 90
Rate of postoperative stenosis
Time frame: throughout the duration of the study (until last follow-up at postoperative day 90)
Length of hospitalization
Time frame: until discharge (approximately 10 days postoperatively)
Re-admissions to hospital
Time frame: throughout the duration of the study (until last follow-up at postoperative day 90)
Surgical reoperations
Time frame: throughout the duration of the study (until last follow-up at postoperative day 90)
Anastomotic leakage free survival
Time frame: throughout the duration of the study (until last follow-up at postoperative day 90)
Rate of intraluminal hemorrhage
Time frame: throughout the duration of the study (until last follow-up at postoperative day 90)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Dulce Momblán García, Dr. principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer and Esophagus Cancer, run by Aesculap AG at 1 site in Spain.
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 4 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 21 Sep 2026. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients with anastomotic leakage (time frame: throughout the duration of the study (until last follow-up at postoperative day 90)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2026.