Clinical trial NCT01783158: Chromoendoscopy to Detect Early Synchronous Second Primary Esophageal Carcinoma
Official title: Chromoendoscopy to Detect Early Synchronous Second Primary Esophageal Carcinoma in Patients With Squamous Cell Carcinomas of the Head and Neck?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Squamous Cell Carcinomas of the Head and Neck
Keywords: head and neck carcinoma
chromoendoscopy
Lugol's solution
esophageal carcinoma
synchronous tumors
deglutition
deglutition disorders
Newly diagnosed HNSCC
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2013-02-04
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed head and neck carcinoma

Brief summary: Patients with HNSCC represent a high-risk group for the development of SESCC. Thus, esophagogastrofibroscopy should be performed to detect possible synchronous esophageal carcinomas in these patients.

Although only two patients with synchronous primary carcinomas were found among the patients with newly diagnosed HNSCC in this study, esophagoscopy and better some of advanced endoscopic methods should be recommended after detection of HNSCC to exclude secondary esophageal carcinoma or dysplasia. Staining of the esophagus with Lugol's solution is an easy and inexpensive option and can be done in most of gastroenterology offices.

Detailed description: ABSTRACT Objective: To evaluate the use of flexible esophagoscopy and chromoendoscopy with Lugol's solution in the detection of early esophageal carcinomas (second primary carcinomas) in patients with squamous cell carcinoma of the head and neck (HNSCC).

Methods: All patients with newly diagnosed HNSCC underwent office-based Lugol chromoendoscopy. After flexible esophagoscopy with white light, 3.0% Lugol iodine solution was sprayed over the entire esophageal mucosa. Areas with less-intense staining (LVLs) were evaluated and biopsies taken.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed patients with head and neck carcinoma
* Age 18-65

Exclusion Criteria:

* Recurrent head and neck carcinomas
* Previously diagnosed oesophageal cancer

Primary outcomes:
measure: To detect early synchronous second primary esophageal carcinoma
timeFrame: The primary measure was assessed immediately after the completion of the study by individual patients.
Secondary outcomes:
Other outcomes:
Locations:
city: Ostrava
country: Czech Republic
facility: University Hospital Ostrava
Study officials:
affiliation: University Hospital Ostrava
name: Pavel Kominek, MD, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Muto M, Hironaka S, Nakane M, Boku N, Ohtsu A, Yoshida S. Association of multiple Lugol-voiding lesions with synchronous and metachronous esophageal squamous cell carcinoma in patients with head and neck cancer. Gastrointest Endosc. 2002 Oct;56(4):517-21. doi: 10.1067/mge.2002.128104.
citation: SLAUGHTER DP, SOUTHWICK HW, SMEJKAL W. Field cancerization in oral stratified squamous epithelium; clinical implications of multicentric origin. Cancer. 1953 Sep;6(5):963-8. doi: 10.1002/1097-0142(195309)6:53.0.co;2-q. No abstract available.
citation: Fukuhara T, Hiyama T, Tanaka S, Oka S, Yoshihara M, Arihiro K, Chayama K. Characteristics of esophageal squamous cell carcinomas and lugol-voiding lesions in patients with head and neck squamous cell carcinoma. J Clin Gastroenterol. 2010 Feb;44(2):e27-33. doi: 10.1097/MCG.0b013e3181b31325.