Clinical trial · Interventional
Influence of Esophageal Washout on Local Carcinoma Recurrence After Curative Resection
Influence of Esophageal Washout on Local Carcinoma Recurrence After Curative Resection - a Randomized Controlled Trial
- 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 LOCARE-Trial is an investigator initiated, randomized-controlled trial with two parallel arms (n=60 each) and investigates the influence of esophageal washout on long-term outcomes in patients undergoing elective esophageal resection for carcinoma. The primary endpoint is defined as local carcinoma recurrence. Secondary endpoints will be locoregional and distant recurrence, disease-specific survival and esophageal cancer specific survival.
Conditions
Conditions (1)
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 Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Povidone-Iodine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A (Povidone-Iodine)
- description
- Esophageal washout will be performed via a nasogastric tube with approx. 50ml of a 11% povidone-iodine solution (Betaisodona®, Mundipharma) during esophageal resection.
- interventionNames
- Drug: Povidone-Iodine
- type
- NO_INTERVENTION
- label
- B (Control)
- description
- Esophageal resection will be performed without esophageal washout.
Primary outcomes (1)
- measure
- Local carcinoma recurrence
- timeFrame
- 36 months
- description
- Defined as development of a local recurrence after surgical treatment for esophageal cancer. The tumor is of identical histopathological type and occurs either on remained parts of the esophagus, at the site of anastomosis, on parts of an interposed organ (i.e. jejunum or colon) or in the original esophageal bed.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients scheduled for elective esophageal resection or esophagectomy * Age equal or greater than 18 years * Written informed consent * Squamous cell carcinoma of the esophagus (SCC) * Adenocarcinoma of the gastroesophageal junction (AEG) Type I Exclusion Criteria: * Local irresectability or metastatic disease * Adenocarcinoma of the gastroesophageal junction Type II and III * Histopathological R1-resection * Surgery for recurrence * Iodine allergy * Hyperthyreosis
References
Publications (0)
Data not yet available