Clinical trial NCT05208775: A Comparative Study of Endoscopic Submucosal Dissection and Photodynamic Therapy for Early Esophageal Cancer
Official title: A Phase III, Randomized, Controlled Study of Endoscopic Submucosal Dissection Versus Photodynamic Therapy for Early Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Carcinoma in Situ AJCC V7
Keywords: Early esophageal carcinoma
Photodynamics Therapy
Endoscopic submucosal dissection
Lead sponsor: The First Affiliated Hospital of Henan University of Science and Technology
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 2-year disease-free survival rate
timeFrame: 2 year
Secondary outcomes:
measure: Esophageal stenosis rate at 3 months
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital and College of Henan University of Science and Technology
name: Shegan Gao, MD, PhD
role: STUDY_CHAIR
affiliation: The First Affiliated Hospital and College of Henan University of Science and Technology
name: Tanyou Shan, MD, PhD
role: STUDY_DIRECTOR
affiliation: The First Affiliated Hospital and College of Henan University of Science and Technology
name: Lijuan Wu, MD, PhD
role: STUDY_DIRECTOR
affiliation: The First Affiliated Hospital and College of Henan University of Science and Technology
name: Caihong Dong, MD，PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital and College of Henan University of Science and Technology
name: Jiachun Sun, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital and College of Henan University of Science and Technology
name: Wanying Li, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital and College of Henan University of Science and Technology
name: Xiaozhi Yuan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital and College of Henan University of Science and Technology
name: Mengxi Zhang, MD
role: PRINCIPAL_INVESTIGATOR
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