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

January 17, 2022 updated by: The First Affiliated Hospital of Henan University of Science and Technology

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PDT group
After enrollment, patients were injected with photosensitizer at a dose of 2mg/kg, and received photodynamic irradiation 48 hours later.
Procedure: 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.

Other Names:
  • Photodynamics Therapy
Active Comparator: ESD group
Patients received standard ESD treatment after enrollment
Procedure: ESD
The patients received standard endoscopic submucosal dissection after enrollment.
Other Names:
  • Endoscopic submucosal dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-year disease-free survival rate
Time Frame: 2 year
The percent of 2 year disease-free survival after random allocation, percent
2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Esophageal stenosis rate at 3 months
Time Frame: 3 months
Stenosis rate of esophagus after 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Henan University of Science and Technology

Investigators

  • Study Chair: Shegan Gao, MD, PhD, The First Affiliated Hospital and College of Henan University of Science and Technology
  • Study Director: 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
  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2022

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 30, 2024

Study Registration Dates

First Submitted

January 10, 2022

First Submitted That Met QC Criteria

January 17, 2022

First Posted (Actual)

January 26, 2022

Study Record Updates

Last Update Posted (Actual)

January 26, 2022

Last Update Submitted That Met QC Criteria

January 17, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECPDT-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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