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

Not Applicable

Not yet recruiting

• Conditions: Esophageal Carcinoma in Situ AJCC V7
• Interventions: Procedure: ESD; Procedure: PDT

• Registration Number: NCT05208775
• Lead Sponsor: The First Affiliated Hospital of Henan University of Science and Technology

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.

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2022-01-10
• Study First Submitted QC: 2022-01-17
• Last Update Submitted: 2022-01-17
• Study First Posted: 2022-01-26
• Last Update Posted: 2022-01-26
• Study Start: 2022-03-01
• Primary Completion: 2022-12-31
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESD group	ESD	Patients received standard ESD treatment after enrollment
PDT group	PDT	After enrollment, patients were injected with photosensitizer at a dose of 2mg/kg, and received photodynamic irradiation 48 hours later.

Primary Outcome Measures

Name	Time	Method
2-year disease-free survival rate	2 year	The percent of 2 year disease-free survival after random allocation, percent

Secondary Outcome Measures

Name	Time	Method
Esophageal stenosis rate at 3 months	3 months	Stenosis rate of esophagus after 3 months