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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03450447
• Other study ID #: 2018SDU-QILU-G02
• Status: Not yet recruiting
• Phase: N/A
• First received: February 10, 2018
• Last updated: February 27, 2018
• Start date: March 10, 2018
• Est. completion date: May 7, 2020

Study information

• Verified date: February 2018
• Source: Shandong University
• Contact: Yanqing Li
• Phone: 18678827666
• Email: liyanqing[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: May 7, 2020
• Est. primary completion date: February 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Cancer Stage
• Esophageal Neoplasms
• Head and Neck Cancer
• Head and Neck Neoplasms

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Yanqing Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	The hospital stay of enrolled patients	The total hospital stay during the first hospitalization of the enrolled patients	An average of 1 month.
Secondary	The incidence of stenosis	The average interval of the stenosis	an average of 2 years
Secondary	The severity of stenosis	The average diameter of the stenosis	an average of 2 years