Standardized Management of Esophageal Fistula in Esophageal Squamous Cell Carcinoma

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorPeking University Cancer Hospital & Institute

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

Treatment groups

32 Participants
are divided into 1 treatment group

Locations

This trial has no locations