A Comparative Study of Endoscopic Submucosal Dissection and Photodynamic Therapy for Early Esophageal Cancer

Study Overview
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Brief Summary
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The purpose of this study was to compare the efficacy and safety of Photodynamic therapy (PDT) and Endoscopic submucosal (ESD) dissection in the treatment of early esophageal cancer.

Detailed Description
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Background: Photodynamic therapy (PDT) is recommended by the NCCN guidelines as an effective method for the treatment of early esophageal cancer. However, there is no clinical trial data so far on whether its efficacy can be compared with that of standard Endoscopic submucosal (ESD). Our team will conduct a detailed study on it. Aim: to compare the efficacy and safety of Photodynamic therapy (PDT) and Endoscopic submucosal (ESD) dissection in the treatment of early esophageal cancer. Methods: This study intends to recruit 46 patients with early esophageal cancer and randomly divide them into two groups: one group to receive ESD and the other group to receive PDT.The efficacy and safety were observed after 2 years of follow-up. Primary endpoints: The recurrence rates at 3 months, 6 months, and 2 years were compared.

Official Title
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A Phase III, Randomized, Controlled Study of Endoscopic Submucosal Dissection Versus Photodynamic Therapy for Early Esophageal Cancer

Conditions
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Esophageal Carcinoma in Situ AJCC V7

Intervention / Treatment
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* Procedure: PDT
* Procedure: ESD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: High-grade intraepithelial neoplasia of the esophagus 18-80 years old The tumor was confined to the lamina propria of the mucosa The tumor invaded the submucosa and was limited to 200 microns Exclusion Criteria: The tumor invaded the entire circumference of the esophagus The tumor invaded the muscularis or submucosa more than 200 microns The patient has difficulty tolerating anesthesia due to other diseases Pregnant or breastfeeding women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PDT group<br>After enrollment, patients were injected with photosensitizer at a dose of 2mg/kg, and received photodynamic irradiation 48 hours later. | Procedure: PDT<br>* Drug: (Hematoporphyrin sodium injection) Hematoporphyrin sodium injection (xibofen):2mg/kg I.V. Laser irradiation: 48 hours after the patient input the photosensitizer, the laser irradiation time is 900 seconds, and the output power is 200 watts.<br>* Other names: Photodynamics Therapy;|
| Active Comparator: ESD group<br>Patients received standard ESD treatment after enrollment | Procedure: ESD<br>* The patients received standard endoscopic submucosal dissection after enrollment.<br>* Other names: Endoscopic submucosal dissection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-year disease-free survival rate | The percent of 2 year disease-free survival after random allocation, percent | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Esophageal stenosis rate at 3 months | Stenosis rate of esophagus after 3 months | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early esophageal carcinoma, Photodynamics Therapy, Endoscopic submucosal dissection