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

Henan University of Science and Technology

Status: Not yet enrolling

Conditions: Esophageal Carcinoma in Situ AJCC V7

Treatments: Procedure: ESD; Procedure: PDT

Study type: Interventional

Funder types: Other

Identifiers

NCT05208775

ECPDT-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

PDT group

Experimental group

Description:

After enrollment, patients were injected with photosensitizer at a dose of 2mg/kg, and received photodynamic irradiation 48 hours later.

Treatment:

Procedure: PDT

ESD group

Active Comparator group

Description:

Patients received standard ESD treatment after enrollment

Treatment:

Procedure: ESD