It is a study to determine feasibility of performing cytosponge (EsophaCap) study in early stage esophagus cancer.
Not Applicable
- Conditions
- Health Condition 1: K228- Other specified diseases of esophagus
- Registration Number
- CTRI/2020/06/025579
- Lead Sponsor
- TATA Memorial Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Confirmed diagnosis of esophageal squamous cell carcinoma
Minimal or grade I dysphagia â?? defined as ability to swallow solids and semisolids
If prior endoscopy done outside, gap between endoscopy and capsule swallow
should be at least 7 days or more.
Willing to undergo an additional procedure (sponge cytology) in addition to
endoscopy for cancer diagnosis
Exclusion Criteria
Patients with dysphagia to solids, inability to swallow tablets, current head and neck
or upper aerodigestive tract cancer, esophageal varices, cirrhosis or portal
hypertension, severe pulmonary disease, stroke or myocardial infarction in the past 6
months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method acceptability and tolerability of cytosponge study in esophagus cancer patientsTimepoint: Same day as of procedure- <br/ ><br>Acceptibility and tolerability will be assessed with Visual Analogue Scale immediately after procedure.
- Secondary Outcome Measures
Name Time Method se of sponge cytology in diagnosis of squamous cell carcinoma of esophagus. <br/ ><br>Tolerability of this procedure when compared of esophagoduodenoscopy.Timepoint: Within 2 weeks of procedure- <br/ ><br>Cytology result will be available within 2 weeks