Long-term Outcomes of Superficial Esophageal Squamous Cell Carcinoma

NCT02908204 | Unknown

• 1 other identifier: SGZAHGX
• Study Type: observational
• Target: 1,800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Esophageal Neoplasms

Keywords

superficial esophageal squamous cell carcinoma; efficacy; survival

Outcome Measures

Primary Outcomes (1)

• Overall survival

  3 years after treatment

Secondary Outcomes (3)

• Recurrence rate

  3 years after treatment

• Short-term complications incidence rate

  30 days after treatment

• Long-term complications incidence rate

  3 years after treatment

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• Tongji Hospital: collaborator
• The affiliated Hospital of Shihezi University: collaborator

Study Sites (1)

Zhongshan Hospital,

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Shiyao CHEN, PhD

CONTACT

13601767310; chen.shiyao@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: September 20, 2016
• Study Start: October 1, 2016
• Primary Completion: October 1, 2017
• Last Updated: September 21, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)