Clinical trial · Interventional
Preemptive Endoluminal Negative Pressure in Minimally Invasive Transthoracic Esophagectomy
Preemptive Endoluminal Negative Pressure Therapy at the Anastomotic Site in Minimally Invasive Transthoracic Esophagectomy - An International Multicenter Randomized Controlled Trial
NCT04162860CI-TRIAL-00042237unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Leak, Anastomotic | — | UNRESOLVED | — |
| Surgery--Complications | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Eso-SPONGE® device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- minimally invasive esophagectomy with preemptive ENP
- description
- 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.
- interventionNames
- Device: Eso-SPONGE® device
- type
- NO_INTERVENTION
- label
- Standard minimally invasive esophagectomy
- description
- Patients in the control group will undergo a standard minimally invasive transthoracic Ivor Lewis esophagectomy without preemptive ENP.
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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+)
References
Publications (1)
- DERIVEDMuller 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. PMID 34013139