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

• Conditions: Head and Neck Cancer; Esophageal Cancer Stage

• Registration Number: NCT03450447
• Lead Sponsor: Yanqing Li

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.

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 Timeline

• Status Verified: 2018-02
• Study First Submitted: 2018-02-10
• Study First Submitted QC: 2018-02-27
• Last Update Submitted: 2018-02-27
• Study First Posted: 2018-03-01
• Last Update Posted: 2018-03-01
• Study Start: 2018-03-10
• Primary Completion: 2020-02-07
• Study Completion: 2020-05-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The first day of food intake of enrolled patients	An average of 1week	The first day of food intake after surgery of the head and neck carcinoma

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China