Clinical trial NCT03450447: Outcomes of A Novel Treatment Decision of Patients With Esophageal and Head and Neck Carcinoma Synchronously
Official title: Outcomes of a Novel Treatment Decision of Patients With Superficial Esophageal Carcinoma Synchronously Associated With Head and Neck Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Head and Neck Cancer
Esophageal Cancer Stage
Keywords: Head and Neck Cancer
Esophageal Cancer
endoscopic submucosal dissection
quality of life
median survival time
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2018-03-01
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with head and ncek carcinoma and synchronous superficial esophageal squamous cell carcinoma.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The first day of food intake of enrolled patients
timeFrame: An average of 1week
Secondary outcomes:
measure: The relapse rate of the enrolled patients
timeFrame: an average of 2 years
measure: The hospital stay of enrolled patients
timeFrame: An average of 1 month.
measure: The incidence of stenosis
timeFrame: an average of 2 years
measure: The severity of stenosis
timeFrame: an average of 2 years
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Department of Gastroenterology, Qilu Hospital, Shandong University
name: Yanqing Li
role: STUDY_DIRECTOR
References: