[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620124":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":19,"locations":10,"responsibleParty":25,"collaborators":10,"id":27,"slug":10,"hasResults":28,"nctId":29,"briefTitle":30,"officialTitle":31,"acronym":32,"eligibilityCriteria":33,"healthyVolunteers":28,"sex":34,"minAge":35,"maxAge":36,"enrollmentInfo":37,"targetDuration":40,"studyType":41,"phases":10,"briefSummary":42,"conditions":43,"keywords":46,"overallStatus":54,"whyStopped":10,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":10},{"fullName":5,"class":6},"Peking University Cancer Hospital & Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Standardized Management Cohort",null,"All enrolled patients with advanced esophageal squamous cell carcinoma and newly diagnosed esophageal fistula who receive the standardized diagnosis and treatment protocol.",[13],"Other: Standardized Management Protocol for Esophageal Fistula",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"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\u002Fairway 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.",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},"Zhihao Lu","CONTACT","+85201088196561","pppeirain@126.com",{"type":26,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100620124",false,"NCT07353541","Standardized Management of Esophageal Fistula in Esophageal Squamous Cell Carcinoma","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","PKU-ESCC-EF","Inclusion Criteria:\n\n* Voluntary participation and provision of written informed consent.\n* Age between 18 and 75 years (inclusive).\n* Histologically confirmed diagnosis of esophageal squamous cell carcinoma.\n* Radiologically confirmed unresectable, advanced disease.\n* Newly diagnosed esophageal fistula (including tracheoesophageal fistula or mediastinal esophageal fistula).\n* Previous receipt of ≤ 3 lines of systemic anti-tumor therapy.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Adequate organ and marrow function within 7 days prior to potential anti-tumor treatment, as defined by:\n* Hemoglobin ≥ 9.0 g\u002FdL\n* Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL\n* Platelet count ≥ 100 × 10⁹\u002FL\n* Total bilirubin (TBIL) ≤ 1.5 × the upper limit of normal (ULN)\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (or ≤ 5 × ULN in the presence of liver metastases)\n* Serum creatinine ≤ 1.5 × ULN\n* Adequate cardiac, pulmonary, and renal function to be eligible for general anesthesia, with no contraindications to general anesthesia.\n\nExclusion Criteria:\n\n* Patients with postoperative anastomotic fistula.\n* Uncontrolled active bleeding.\n* Presence of a concurrent primary malignancy other than esophageal carcinoma.\n* Clinically significant cardiovascular disease, including but not limited to:\n* Heart failure (NYHA Class III-IV)\n* Uncontrolled coronary artery disease, cardiomyopathy, or arrhythmia\n* Uncontrolled hypertension\n* History of myocardial infarction within the past 1 year\n* Neurological or psychiatric disorders that impair cognitive ability, including the presence of central nervous system metastases.\n* 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).\n* Known or self-reported HIV infection, or active Hepatitis B or Hepatitis C.\n* A history of interstitial lung disease (e.g., interstitial pneumonia, pulmonary fibrosis), or evidence of interstitial lung disease on baseline chest X-ray\u002FCT.","ALL","18 Years","75 Years",{"count":38,"type":39},32,"ESTIMATED","6 Months","OBSERVATIONAL","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.",[44,45],"Esophageal Squamous Cell Carcinoma (ESCC)","Esophageal Fistula",[47,45,48,49,50,51,52,53],"Esophageal Squamous Cell Carcinoma","Standardized Management","Stent Placement","Nutritional Support","Observational Study","Registry Study","Real-world Evidence","NOT_YET_RECRUITING","2026-01-18",{"date":57,"type":58},"2026-01-20","ACTUAL",{"date":60,"type":39},"2026-02-01",{"date":62,"type":39},"2026-04-01",{"name":5,"class":6}]