Long-term Outcomes of Superficial Esophageal Squamous Cell Carcinoma

September 19, 2016 updated by: Shiyao Chen, Shanghai Zhongshan Hospital

Long-term Outcomes After Treatment for Superficial Esophageal Squamous Cell Carcinoma

Tumor is the primary public health problem and the incidence of esophageal cancer showed the increasing trend in the past thirty years. According to the statistics in 2015, the new onset of esophageal cancer is about 477,900 yearly. The mainly pathologic type of esophageal cancer in China is esophageal squamous cell carcinomas, which accounts for more than 90% of patients in China. With the development of endoscopic technics, more and more patients choose to receive the endoscopic procedure rather than traditional surgery. However, the long-term efficacy and outcomes of patients with superficial esophageal squamous cell carcinoma received different interventions remained unclear. Thus, investigators aim to conduct a multi-center retrospective study to investigate the long term outcomes of superficial esophageal squamous cell carcinoma patients receiving endoscopic treatment and surgery.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

1800

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 Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with superficial esophageal squamous cell carcinoma underwent endoscopic treatment or traditional surgery.

Description

Inclusion Criteria:

  • Patients received endoscopic treatment because of the superficial esophageal disease and had the pathologic diagnosis of squamous cell carcinoma.

Exclusion Criteria:

  • Combined with other severe disease
  • With a history of esophageal surgery
  • Combined with other malignant disease

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Endoscopic treatment
Patients underwent endoscopic treatment including Endoscopic Mucosal Resection (EMR), Endoscopic Submucosal Dissection (ESD), Multiband Mucosectomy (MBM), Endoscopic Mucosal Band Ligation(EMBL) and so on.
Traditional surgery
Patients underwent traditional surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 3 years after treatment
3 years after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Recurrence rate
Time Frame: 3 years after treatment
3 years after treatment
Short-term complications incidence rate
Time Frame: 30 days after treatment
30 days after treatment
Long-term complications incidence rate
Time Frame: 3 years after treatment
3 years after treatment

Collaborators and Investigators

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

Sponsor

Shanghai Zhongshan Hospital

Collaborators

Tongji Hospital
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
The affiliated Hospital of Shihezi University

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

October 1, 2016

Primary Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

September 14, 2016

First Submitted That Met QC Criteria

September 16, 2016

First Posted (Estimate)

September 20, 2016

Study Record Updates

Last Update Posted (Estimate)

September 21, 2016

Last Update Submitted That Met QC Criteria

September 19, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGZAHGX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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