A Comparative Study of Endoscopic Submucosal Dissection and Photodynamic Therapy for Early Esophageal Cancer
NCT ID: NCT05208775
Last Updated: 2022-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
46 participants
INTERVENTIONAL
2022-03-01
2024-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PDT group
After enrollment, patients were injected with photosensitizer at a dose of 2mg/kg, and received photodynamic irradiation 48 hours later.
PDT
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.
ESD group
Patients received standard ESD treatment after enrollment
ESD
The patients received standard endoscopic submucosal dissection after enrollment.
Interventions
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PDT
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.
ESD
The patients received standard endoscopic submucosal dissection after enrollment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 muscularis or submucosa more than 200 microns
* The patient has difficulty tolerating anesthesia due to other diseases
* Pregnant or breastfeeding women
18 Years
80 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Henan University of Science and Technology
OTHER
Responsible Party
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Principal Investigators
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Shegan Gao, MD, PhD
Role: STUDY_CHAIR
The First Affiliated Hospital and College of Henan University of Science and Technology
Tanyou Shan, MD, PhD
Role: STUDY_DIRECTOR
The First Affiliated Hospital and College of Henan University of Science and Technology
Lijuan Wu, MD, PhD
Role: STUDY_DIRECTOR
The First Affiliated Hospital and College of Henan University of Science and Technology
Caihong Dong, MD，PhD
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital and College of Henan University of Science and Technology
Jiachun Sun, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital and College of Henan University of Science and Technology
Wanying Li, MD
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital and College of Henan University of Science and Technology
Xiaozhi Yuan, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital and College of Henan University of Science and Technology
Mengxi Zhang, MD
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital and College of Henan University of Science and Technology
Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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ECPDT-002
Identifier Type: -
Identifier Source: org_study_id
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