Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PDT group | Experimental | After enrollment, patients were injected with photosensitizer at a dose of 2mg/kg, and received photodynamic irradiation 48 hours later. |
|
| ESD group | Active Comparator | Patients received standard ESD treatment after enrollment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PDT | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year disease-free survival rate | The percent of 2 year disease-free survival after random allocation, percent | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Esophageal stenosis rate at 3 months | Stenosis rate of esophagus after 3 months | 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shegan Gao, MD, PhD | Contact | 18638859977 | gsg112258@163.com | |
| Tanyou Shan, MD, PhD | Contact | 18537976669 | shantanyoudoctor@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Shegan Gao, MD, PhD | The First Affiliated Hospital and College of Henan University of Science and Technology | Study Chair |
| Tanyou Shan, MD, PhD | The First Affiliated Hospital and College of Henan University of Science and Technology |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34202917 | Background | Yano T, Minamide T, Takashima K, Nakajo K, Kadota T, Yoda Y. Clinical Practice of Photodynamic Therapy Using Talaporfin Sodium for Esophageal Cancer. J Clin Med. 2021 Jun 24;10(13):2785. doi: 10.3390/jcm10132785. | |
| 31156297 | Background | National Health Commission Of The People's Republic Of China. Chinese guidelines for diagnosis and treatment of esophageal carcinoma 2018 (English version). Chin J Cancer Res. 2019 Apr;31(2):223-258. doi: 10.21147/j.issn.1000-9604.2019.02.01. No abstract available. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C008848 | 1-phenyl-3,3-dimethyltriazene |
| D000069916 | Endoscopic Mucosal Resection |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| ESD | Procedure | The patients received standard endoscopic submucosal dissection after enrollment. |
|
|
| Lijuan Wu, MD, PhD | The First Affiliated Hospital and College of Henan University of Science and Technology | Study Director |
| Caihong Dong, MD，PhD | The First Affiliated Hospital and College of Henan University of Science and Technology | Principal Investigator |
| Jiachun Sun, MD, PhD | The First Affiliated Hospital and College of Henan University of Science and Technology | Principal Investigator |
| Wanying Li, MD | The First Affiliated Hospital and College of Henan University of Science and Technology | Principal Investigator |
| Xiaozhi Yuan, MD, PhD | The First Affiliated Hospital and College of Henan University of Science and Technology | Principal Investigator |
| Mengxi Zhang, MD | The First Affiliated Hospital and College of Henan University of Science and Technology | Principal Investigator |
| 32578508 | Background | Zeng R, Liu C, Li L, Cai X, Chen R, Li Z. Clinical Efficacy of HiPorfin Photodynamic Therapy for Advanced Obstructive Esophageal Cancer. Technol Cancer Res Treat. 2020 Jan-Dec;19:1533033820930335. doi: 10.1177/1533033820930335. |
| 23019392 | Background | Yoon HY, Cheon YK, Choi HJ, Shim CS. Role of photodynamic therapy in the palliation of obstructing esophageal cancer. Korean J Intern Med. 2012 Sep;27(3):278-84. doi: 10.3904/kjim.2012.27.3.278. Epub 2012 Sep 1. |
| 28983230 | Background | Itabashi M, Nasierowska-Guttmejer A, Shimoda T, Majewski P, Rezner W, Sikora K, Srutek E, Steplewska K, Swatek J, Szumilo J, Wierzchniewska-Lawska A, Wronecki L, Zembala-Nozynska E, Arai T, Fujita M, Kawachi H, Unakami M, Kamoshida T. The importance of the concept and histological criteria of "intraepithelial squamous cell carcinoma" of the esophagus: in comparison between Western and Japanese criteria. Esophagus. 2017;14(4):333-342. doi: 10.1007/s10388-017-0583-7. Epub 2017 Jun 14. |
| 30588952 | Background | Zheng JY, Chen YH, Chen YY, Zheng XL, Zhong SS, Deng WY, Zheng JH, Guo XB, Gao LY, Liang W. Presence of pink-color sign within 1 min after iodine staining has high diagnostic accordance rate for esophageal high-grade intraepithelial neoplasia/invasive cancer. Saudi J Gastroenterol. 2019 Mar-Apr;25(2):113-118. doi: 10.4103/sjg.SJG_274_18. |
| 33937514 | Background | Omae M, Hagstrom H, Ndegwa N, Vieth M, Wang N, Vujasinovic M, Baldaque-Silva F. Wide-field endoscopic submucosal dissection for the treatment of Barrett's esophagus neoplasia. Endosc Int Open. 2021 May;9(5):E727-E734. doi: 10.1055/a-1386-3668. Epub 2021 Apr 22. |
| 19152456 | Background | Wu W, Wu YL, Zhu YB, Wei Q, Guo Y, Zhu ZG, Yuan YZ. Endoscopic features predictive of gastric cancer in superficial lesions with biopsy-proven high grade intraepithelial neoplasia. World J Gastroenterol. 2009 Jan 28;15(4):489-95. doi: 10.3748/wjg.15.489. |
| 30922862 | Background | Ke Y, van Munster SN, Xue L, He S, Zhang Y, Dou L, Liu Y, Liu X, Liu Y, Li W, Lv N, Dawsey SM, Weusten BLAM, Bergman JJGHM, Wang G. Prospective study of endoscopic focal cryoballoon ablation for esophageal squamous cell neoplasia in China. Gastrointest Endosc. 2019 Aug;90(2):204-212. doi: 10.1016/j.gie.2019.03.017. Epub 2019 Mar 25. |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |