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NCT07353541

Standardized Management of Esophageal Fistula in Esophageal Squamous Cell Carcinoma

Sponsor: Peking University Cancer Hospital & Institute

View on ClinicalTrials.gov

Summary

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.

Official title: An Evaluation of the Safety and Efficacy of a Standardized Diagnosis and Treatment Protocol for Esophageal Fistula in Patients With Esophageal Squamous Cell Carcinoma: A Single-Arm, Multi-Center Clinical Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

Start Date

2026-02-01

Completion Date

2026-04-01

Last Updated

2026-01-20

Healthy Volunteers

Conditions

Esophageal Squamous Cell Carcinoma (ESCC)Esophageal Fistula

Interventions

OTHER

Standardized Management Protocol for Esophageal Fistula

This is a comprehensive, standardized clinical management protocol for esophageal fistula in advanced esophageal squamous cell carcinoma patients. The protocol integrates multiple standardized components into a unified pathway: (1) systematic diagnosis using iodine-contrast esophagography, chest CT, and endoscopy; (2) interventional fistula sealing with covered esophageal/airway stents selected by fistula characteristics; (3) coordinated adjunctive therapy including anti-infectives, acid suppression, and negative suction; (4) mandatory nutritional assessment with early transition from parenteral to enteral feeding; and (5) a defined pathway for subsequent anti-tumor therapy after clinical recovery. This multi-modal, sequential approach differentiates it from isolated interventions by providing integrated management from diagnosis through nutritional rehabilitation to subsequent oncology care within a standardized framework.

Inclusion Criteria: * 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. * Newly diagnosed esophageal fistula (including tracheoesophageal fistula or mediastinal esophageal fistula). * Previous receipt of ≤ 3 lines of systemic anti-tumor therapy. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. * Adequate organ and marrow function within 7 days prior to potential anti-tumor treatment, as defined by: * Hemoglobin ≥ 9.0 g/dL * Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L * Platelet count ≥ 100 × 10⁹/L * Total bilirubin (TBIL) ≤ 1.5 × the upper limit of normal (ULN) * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (or ≤ 5 × ULN in the presence of liver metastases) * Serum creatinine ≤ 1.5 × ULN * Adequate cardiac, pulmonary, and renal function to be eligible for general anesthesia, with no contraindications to general anesthesia. Exclusion Criteria: * Patients with postoperative anastomotic fistula. * Uncontrolled active bleeding. * Presence of a concurrent primary malignancy other than esophageal carcinoma. * Clinically significant cardiovascular disease, including but not limited to: * Heart failure (NYHA Class III-IV) * Uncontrolled coronary artery disease, cardiomyopathy, or arrhythmia * Uncontrolled hypertension * History of myocardial infarction within the past 1 year * Neurological or psychiatric disorders that impair cognitive ability, including the presence of central nervous system metastases. * Uncontrolled, active severe clinical infection ( \> Grade 2 per NCI-CTCAE version 5.0) within 14 days prior to enrollment, including active tuberculosis (this is a contraindication for anti-tumor therapy, not for interventional procedures). * Known or self-reported HIV infection, or active Hepatitis B or Hepatitis C. * A history of interstitial lung disease (e.g., interstitial pneumonia, pulmonary fibrosis), or evidence of interstitial lung disease on baseline chest X-ray/CT.