Outcomes of A Novel Treatment Decision of Patients With Esophageal and Head and Neck Carcinoma Synchronously

NCT03450447 | Unknown DMC

• 1 other identifier: 2018SDU-QILU-G02
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To summarise the outcomes of a treatment decision of patients with superficial esophageal carcinoma synchronously associated with head and neck cancer, that is endoscopic treatment for the superficial esophageal carcinoma plus surgery of the head and neck carcinoma.

Conditions

Head and Neck Cancer; Esophageal Cancer Stage

Keywords

Head and Neck Cancer; Esophageal Cancer; endoscopic submucosal dissection; quality of life; median survival time

Outcome Measures

Primary Outcomes (1)

• The first day of food intake of enrolled patients

  The first day of food intake after surgery of the head and neck carcinoma

  An average of 1week

Secondary Outcomes (4)

• The relapse rate of the enrolled patients

  an average of 2 years

• The hospital stay of enrolled patients

  An average of 1 month.

• The incidence of stenosis

  an average of 2 years

• The severity of stenosis

  an average of 2 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with head and ncek carcinoma and synchronous superficial esophageal squamous cell carcinoma.

You may qualify if:

• Patients with head and ncek carcinoma associated with synchronous superficial esophageal squamous cell carcinoma.
• Patients agree to be treated with esophageal endoscopic submucosal dissection firstly, then accept surgery of head and neck carcinoma.

You may not qualify if:

• Patients refuse a endoscopic submucosal dissection or surgery.
• Patients with sever systemic disease, such as sever cardiopulmonary disease, renal failure and impaired blood coagulation.
• Obstruction of the pharynx leading to a failure of insertion of endoscopy.
• Patients with an advanced esophageal carcinoma evaluated by endoscopy.

Sponsors & Collaborators

• Yanqing Li: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

histopathology of esophageal endoscopic submucosal dissection specimen histopathology of surgical specimen of head and neck

MeSH Terms

Conditions

Head and Neck Neoplasms; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Yanqing Li

  Department of Gastroenterology, Qilu Hospital, Shandong University

  STUDY DIRECTOR

Central Study Contacts

Yanqing Li

CONTACT

18678827666; liyanqing@sdu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor, chief of gastrointestinal department of Qilu hospital of Shandong University

Study Record Dates

• First Submitted: February 10, 2018
• First Posted: March 1, 2018
• Study Start: March 10, 2018
• Primary Completion: February 7, 2020
• Study Completion: May 7, 2020
• Last Updated: March 1, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: before the start of the study

Locations

CN (1)