Clinical trial · Interventional
Effect of Neck Flexion on Esophagogastric Anastomotic Leakage After MIE
Effect of Neck Flexion on Post-operative Esophagogastric Anastomotic Leakage After Minimally Invasive Esophagectomy: a Single-center 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)
Esophageal cancer (EC) is the eighth most common cancer and the sixth leading cause of cancer deaths worldwide. Minimally invasive esophagectomy (MIE) is regarded as a safe and effective management for resectable EC. Gastric tube is considered to be an ideal substitute for the resected esophagus, and used for cervical esophagogastric anastomoses for digestive tract reconstruction in MIE. However, the tension at the anastomosed area can not be ignored and may cause cervical anastomotic leakage (CAL) in some cases. Continuous neck flexion is a standard post-operative posture after tracheal resection and reconstruction, and aimed to relieve the anastomotic tension. In this study, the investigators attempt to adopt the maneuver in MIE, and observe its effect on relieving the anastomotic tension and decreasing the incidence of CAL.
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 |
|---|---|---|---|
| Anastomotic Leak | — | UNRESOLVED | — |
| Esophageal Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Esophagectomy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| neck flexion | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- neck flexion group
- description
- Patients who fixed in neck flexion position after MIE
- interventionNames
- Procedure: neck flexion
- type
- NO_INTERVENTION
- label
- control group
- description
- Patients without posture intervention after MIE
Primary outcomes (1)
- measure
- Incidence of post-operative cervical esophagogastric anastomotic leakage
- timeFrame
- From the day of operation to hospital discharge (an expected average of 2 weeks)
- description
- The post-operative cervical esophagogastric anastomotic leakage is defined as a radiological defect at the anastomotic site, or leakage of swallowed fluid (saliva, gastric juice or food residue) out of the drain site or cervical wound.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the intrathoracic esophagus. * Surgical resectable (T1-4a, N0-3, M0). * Age≥18 and ≤75 years. * European Clinical Oncology Group (ECOG) performance status 0,1 or 2. * Written informed consent obtain. Exclusion Criteria: * Carcinoma of the cervical esophagus. * Carcinoma of the gastro-esophageal junction (GEJ). * Prior thoracic surgery or trauma on the right hemithorax, or previous diseases which may lead to right pleural adhesion (these patients will undergo open surgery instead of minimally invasive esophagectomy). -Dysfunction of cardiorespiratory system or other surgical contraindications.
References
Publications (0)
Data not yet available