Esophageal Carcinoma in Situ AJCC V7
Conditions
Keywords
Early esophageal carcinoma, Photodynamics Therapy, Endoscopic submucosal dissection
Brief summary
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
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.
Interventions
PROCEDUREPDT
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.
PROCEDUREESD
The patients received standard endoscopic submucosal dissection after enrollment.
Sponsors
The First Affiliated Hospital of Henan University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-year disease-free survival rate | 2 year | The percent of 2 year disease-free survival after random allocation, percent |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Esophageal stenosis rate at 3 months | 3 months | Stenosis rate of esophagus after 3 months |
Contacts
Primary ContactShegan Gao, MD, PhD
Backup ContactTanyou Shan, MD, PhD
Outcome results
None listed