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Brief Title: 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 ID: NCT05208775
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Name: Shegan Gao, MD, PhD
Affiliation: The First Affiliated Hospital and College of Henan University of Science and Technology
Role: STUDY_CHAIR
Name: Tanyou Shan, MD, PhD
Affiliation: The First Affiliated Hospital and College of Henan University of Science and Technology
Role: STUDY_DIRECTOR
Name: Lijuan Wu, MD, PhD
Affiliation: The First Affiliated Hospital and College of Henan University of Science and Technology
Role: STUDY_DIRECTOR
Name: Caihong Dong, MD,PhD
Affiliation: The First Affiliated Hospital and College of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Jiachun Sun, MD, PhD
Affiliation: The First Affiliated Hospital and College of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Wanying Li, MD
Affiliation: The First Affiliated Hospital and College of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Xiaozhi Yuan, MD, PhD
Affiliation: The First Affiliated Hospital and College of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Mengxi Zhang, MD
Affiliation: The First Affiliated Hospital and College of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR