Clinical trial · Interventional

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

A Phase III, Randomized, Controlled Study of Endoscopic Submucosal Dissection Versus Photodynamic Therapy for Early Esophageal Cancer

NCT05208775CI-TRIAL-00056182unknownN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Esophageal Carcinoma in Situ AJCC V7	Esophageal Carcinoma In Situ	CURATED_BROADER	0.78

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
ESD	Procedure	—	UNRESOLVED
PDT	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
PDT group
description
After enrollment, patients were injected with photosensitizer at a dose of 2mg/kg, and received photodynamic irradiation 48 hours later.
interventionNames
1. Procedure: PDT
type
ACTIVE_COMPARATOR
label
ESD group
description
Patients received standard ESD treatment after enrollment
interventionNames
1. Procedure: ESD

Primary outcomes (1)

measure
2-year disease-free survival rate
timeFrame
2 year

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 80 Years

Show eligibility criteria text

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

References

Publications (9)

BACKGROUNDYano 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. PMID 34202917
BACKGROUNDNational 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. PMID 31156297
BACKGROUNDZeng 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. PMID 32578508
BACKGROUNDYoon 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. PMID 23019392
BACKGROUNDItabashi 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. PMID 28983230
BACKGROUNDZheng 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. PMID 30588952