An observational study in Esophageal Cancer, Esophagus Cancer and Anastomotic Leak, sponsored by Aesculap AG. Active, not recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Aesculap AG · Observational
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.
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.
1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.
This study's planned enrollment of 44 is below the median of 200 across 341 observational studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →Aesculap AG is the lead sponsor of 104 studies on the registry; 20 are open to participants now.
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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)
Exclusion Criteria:
endoluminal vacuum therapy to prevent anastomotic leakage after esophagectomy due to esophageal cancer
Device: Eso-SPONGE®
minimally invasive treatment and prevention of anastomotic leakages and perforations in the upper gastrointestinal tract (upper GIT)
Also known as: endoluminal vacuum therapy (EVT) device
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.
Time frame: throughout the duration of the study (until last follow-up at postoperative day 90)
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).
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: throughout the duration of the study (until last follow-up at postoperative day 90)
Plan to share: No
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Aesculap AG