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

NCT05208775 | Unknown

• 1 other identifier: ECPDT-002
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Esophageal Carcinoma in Situ AJCC V7

Keywords

Early esophageal carcinoma; Photodynamics Therapy; Endoscopic submucosal dissection

Outcome Measures

Primary Outcomes (1)

• 2-year disease-free survival rate

  The percent of 2 year disease-free survival after random allocation, percent

  2 year

Secondary Outcomes (1)

• Esophageal stenosis rate at 3 months

  3 months

Study Arms (2)

PDT group

EXPERIMENTAL

After enrollment, patients were injected with photosensitizer at a dose of 2mg/kg, and received photodynamic irradiation 48 hours later.

Procedure: PDT

ESD group

ACTIVE COMPARATOR

Patients received standard ESD treatment after enrollment

Procedure: ESD

Interventions

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.

Also known as: Photodynamics Therapy

PDT group

ESD PROCEDURE

The patients received standard endoscopic submucosal dissection after enrollment.

Also known as: Endoscopic submucosal dissection

ESD group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• High-grade intraepithelial neoplasia of the esophagus
• years old
• The tumor was confined to the lamina propria of the mucosa
• The tumor invaded the submucosa and was limited to 200 microns

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Henan University of Science and Technology: lead

Related Publications (9)

• 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.

  PMID: 34202917 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.

  PMID: 31156297 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.

  PMID: 32578508 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.

  PMID: 23019392 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.

  PMID: 28983230 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.

  PMID: 30588952 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.

  PMID: 33937514 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.

  PMID: 19152456 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.

  PMID: 30922862 BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

1-phenyl-3,3-dimethyltriazene; Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• 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

  STUDY DIRECTOR

• 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

Central Study Contacts

Shegan Gao, MD, PhD

CONTACT

18638859977; gsg112258@163.com

Tanyou Shan, MD, PhD

CONTACT

18537976669; shantanyoudoctor@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 26, 2022
• Study Start: March 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 30, 2024
• Last Updated: January 26, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share