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

Outcomes of a Novel Treatment Decision of Patients With Superficial Esophageal Carcinoma Synchronously Associated With Head and Neck Cancer

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.

Study Overview

• Status: Unknown
• Conditions: Head and Neck Cancer; Esophageal Cancer Stage

Detailed Description

As a same risk factor, such as heavy drinking and smoking, patients with head and ncek carcinoma are always suffering from synchronous esophageal squamous cell carcinoma. Previous studies illustrated that many patients with multiple esophageal lesions of early stage. In clinical practice, those patients are treated by extensive surgical resection of total pharyngo-laryngo-esophagectomy plus free jejunum interposition or gastric tube, then followed by chemoradiotherapy as standard treatment, resulting in a low quality of life for the patients, and due to the above mentioned disadvantages, many patients with synchronous superficial esophageal squamous cell carcinoma and head and neck carcinoma refused the surgery treatment. Our aims is to summarize the the outcomes of endoscopic treatment for the superficial esophageal carcinoma plus surgery of head and neck carcinoma.

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital of Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The relapse rate of the enrolled patients	the relapse rate of esophageal cancer or head and neck carcinoma respectively of the enrolled patients.	an average of 2 years
The hospital stay of enrolled patients	The total hospital stay during the first hospitalization of the enrolled patients	An average of 1 month.
The incidence of stenosis	The average interval of the stenosis	an average of 2 years
The severity of stenosis	The average diameter of the stenosis	an average of 2 years

Collaborators and Investigators

• Sponsor: Yanqing Li
• Investigators: Study Director: Yanqing Li, Department of Gastroenterology, Qilu Hospital, Shandong University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 10, 2018
• Primary Completion (ANTICIPATED): February 7, 2020
• Study Completion (ANTICIPATED): May 7, 2020

Study Registration Dates

• First Submitted: February 10, 2018
• First Submitted That Met QC Criteria: February 27, 2018
• First Posted (ACTUAL): March 1, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 1, 2018
• Last Update Submitted That Met QC Criteria: February 27, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Head and Neck Cancer; quality of life; Esophageal Cancer; endoscopic submucosal dissection; median survival time
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Esophageal Diseases; Head and Neck Neoplasms; Esophageal Neoplasms
• Other Study ID Numbers: 2018SDU-QILU-G02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all the clinical features of the patient are available to all the researchers
• IPD Sharing Time Frame: before the start of the study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No