Esophagus cancer
Conditions
Interventions
Control group:Single local submucosal steroid injection and oral steroid
Experimental group:Modified submucosal steroid injection
Sponsors
The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients who endoscopically and histologically confirmed superficial esophagus cancer expected to result in a mucosal defect involving the entire esophageal circumference after ESD ; 2. age >=18 and <= 80 years; 3. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Submucosal invasion exceeding 200 micrometers (> SM1) in pretreatment endoscopic findings; 2. Lymph node metastases or distant metastases detected by computed tomography; 3. Lesions involving oesophageal diverticula, or oesophageal ulcers; 4. Presence of tumors originating from the intrinsic muscular layer within the lesion; 5. Synchronous malignancies outside the oesophagus or elsewhere in the oesophagus (except superficial oesophageal cancer with submucosal invasion less than 200 microns); 6. Combination with other oesophageal diseases, including oesophageal varices, oesophageal strictures, candida oesophagitis, congenital anatomical anomalies, oesophageal fistulas, oesophageal diseases with symptoms that can cause dysphagia (e.g., pancreatic achalasia, diffuse oesophageal spasms, hunter's oesophagus); 7. Prior or receiving radiotherapy and/or radiotherapy for esophageal cancer; 8. Prior radiotherapy to the neck, chest wall, lung or mediastinum; 9. Major lesion located within 20 mm from past scar due to various causes (e.g., ESD, ucler); 10. Prior surgery for esophagus or mediastinum; 11. Active systemic infection, including clinical evidence of active tuberculosis infection (nodules, cavities, tuberculoma etc), systemic fungal infection (excluding fungal infections of nail); 12. Positive test results for hepatitis B surface antigen (HBsAg), hepatitis B core - antibody (HBcAb), or hepatitis C virus (HCV) serology at screening; 13. Patients with positive blood test for HIV; 14. Inherited or acquired severe immune deficiency; 15. Any history of oral or systemic corticosteroids or immunosuppressant medication within 12 weeks prior to randomization; 16. Active peptic ulcer disease; 17. Glaucoma, posterior capsule opacification, or herpetic keratitis; 18. Coagulopathy (international normalised ratio >1.5, platelets =50×109/L); 19. Severe organ failure, such as liver, kidney, respiratory failure, brain dysfunction, etc; 20. Unstable angina or advanced ischemic cardiopathy (extensive myocardial infarction within the last 3 months or post-infarction heart failure); 21. Severe heart failure (NYHA Class III or IV) or severe uncontrolled cardiac disease; 22. Diabetes mellitus requiring the routine administration of insulin, or HbA1c = 7.0%; 23. Systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg within 30 days of randomization date, even with regular use of antihypertensive medication. 24. Inability to tolerate intravenous anesthesia; 25. Severe psychiatric disease; 26. Women pregnant or lactating or intending to become pregnant during the study; 27. Hypersensitivity for triamcinolone acetonide or prednisolone; 28. Participation in another interventional clinical trial prior to randomization; 29. Karnofsky index < 50%; 30. Major surgery within 4 weeks prior to randomization, excluding diagnostic surgery; 31. Inability to participate in follow-up (ie, incarcerated, without access to phone, email);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of esophageal stricture at 3 months after ESD; | — |
Secondary
| Measure | Time frame |
|---|---|
| The number of sessions of endoscopic balloon dilation (EBD);Dysphagia score;Treatment costs;length of hospital stays;The time to stricture;The rate of adverse events;Oesophageal Cancer-specific Quality of Life Module; | — |
Countries
China
Contacts
Public ContactXin Yang
The First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed