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Status unknownNCT03450447Updated Mar 1, 2018

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

An observational study in Head and Neck Cancer and Esophageal Cancer Stage, sponsored by Yanqing Li. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2018-03-01.

Sponsored by Yanqing Li · Observational

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Head and Neck Cancer
  • Esophageal Cancer Stage

Keywords

  • Head and Neck Cancer
  • Esophageal Cancer
  • endoscopic submucosal dissection
  • quality of life
  • median survival time
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
05

What researchers measure

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

    Time frame: An average of 1week

Secondary outcomes

  1. The relapse rate of the enrolled patients

    the relapse rate of esophageal cancer or head and neck carcinoma respectively of the enrolled patients.

    Time frame: an average of 2 years

  2. The hospital stay of enrolled patients

    The total hospital stay during the first hospitalization of the enrolled patients

    Time frame: An average of 1 month.

  3. The incidence of stenosis

    The average interval of the stenosis

    Time frame: an average of 2 years

  4. The severity of stenosis

    The average diameter of the stenosis

    Time frame: an average of 2 years

06

Study locations

1 site
  • Qilu Hospital of Shandong University
    Jinan, Shandong 250012, China
07

References and documents

Individual participant data

Plan to share: Yes — all the clinical features of the patient are available to all the researchers

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03450447
Lead sponsor
Yanqing Li
Responsible party
Yanqing Li (professor, chief of gastrointestinal department of Qilu hospital of Shandong University, Shandong University) — Sponsor-investigator
First posted
Mar 1, 2018
Start date
Mar 10, 2018 (estimated)
Primary completion
Feb 7, 2020 (estimated)
Completion
May 7, 2020 (estimated)
Last update
Mar 1, 2018

Study contacts

Yanqing Li
Contact
liyanqing@sdu.edu.cn
18678827666
Yanqing Li
study director · Department of Gastroenterology, Qilu Hospital, Shandong University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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