About this trial
This prospective, multi-center, observational registry study (PKU-ESCC-EF) aims to evaluate the safety and effectiveness of a standardized diagnosis and treatment protocol for esophageal fistula (EF) in patients with advanced esophageal squamous cell carcinoma (ESCC). Esophageal fistula is a severe complication that often leads to life-threatening infections and poor nutrition. This study will observe patients receiving a comprehensive management strategy, which includes fistula sealing with esophageal or airway stents, targeted anti-infective therapy, nutritional support, and subsequent systemic anti-tumor therapy. The primary goal is to assess whether this standardized approach can improve overall survival and enable more patients to receive further anti-cancer treatments.
Eligibility criteria
Qualifiers
Voluntary participation and provision of written informed consent.
Age between 18 and 75 years (inclusive).
Histologically confirmed diagnosis of esophageal squamous cell carcinoma.
Radiologically confirmed unresectable, advanced disease.
Disqualifiers
Patients with postoperative anastomotic fistula.
Uncontrolled active bleeding.
Presence of a concurrent primary malignancy other than esophageal carcinoma.
Heart failure (NYHA Class III-IV)
Trial design
Treatments tested in this trial
- Standardized Management Protocol for Esophageal Fistula