The aim of this study is to compare the sensitivity of chromoendoscopy with Lugol*s solution with conventional white light video endoscopy in diagnosing esophageal dysplasia and cancer in patients with achalasia.
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary end point is the difference between WLE and CE for detection of
dysplastic
lesions or oesophageal carcinoma during gastroscopy in patients with achalasia.
Secondary outcome
- Histological difference of the lesions detected only by WLE or only by CE
- Duration of the procedure for WLE and CE
Background summary
COMPARING CHROMOENDOSCOPY AND WHITE LIGHT VIDEO ENDOSCOPY FOR ESOPHAGEAL
DYSPLASIA AND CANCER SURVEILLANCE IN PATIENTS WITH ACHALASIA
Achalasia is a rare condition, characterized by a functional obstruction of the
esophagus caused by failed relaxation of the lower oesophageal sphincter (LES)
in combination with absent peristalsis of the distal esophagus. After therapy
food-stasis often persists and can lead to chronic inflammation, hyperplasia of
the epithelium, dysplasia and squamous cell carcinoma (SCC). Achalasia patients
are known to have a considerably increased risk for esophageal cancer, this
risk has been reported to be up to 140 times higher than in the normal
population. For screening or surveillance endoscopy flexible white light
endoscopes are routinely used. Studies evaluating the value of chromoendoscopy
in the detection of early gastro intestinal neoplasia showed promising results.
No studies have been performed to evaluate the clinical significance of
implementing chromoendoscopy as standard surveillance modality for dysplasia
and cancer in patients with achalasia.
Study objective
The aim of this study is to compare the sensitivity of chromoendoscopy with
Lugol*s solution with conventional white light video endoscopy in diagnosing
esophageal dysplasia and cancer in patients with achalasia.
Study design
Observational study with invasive measurements.
Study burden and risks
The burden associated with participation is that the patients have to undergo
two endoscopies instead of one. A gastroscopy is a save investigation. Still
complications can occure ( 1 or 2 times each 1000 gastroscopies). An airway
infection or pneumonia can be caused by aspiration of esophageal- and/ or
stomach-contents. This occures more often in patients who received conscious
sedation. Occasionally a little perforation in the esophagus, or very rarely,
in the stomach, can occur. After biopsy there might occur a bleeding. The more
interventions take place, the greater the risk of complications. A side effect
of chromoendoscopy can be an allergic reaction due to the Lugol's solution
applied to the esophagus as this solution contains iodine. For this reason
people with a known iodine allergy cannot be included in this study.
Hyperthyroidism is an exclusion criterion as well.
's Gravendijkwal 230
3015 CE Rotterdam
Nederland
's Gravendijkwal 230
3015 CE Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
A) Age 18 years or older
B) Patients with primary achalasia as diagnosed according to standard criteria
Exclusion criteria
A) Under 18 years of age
B) Known allergy against iodine
C) Hyperthyroidism
D) Esophageal varices
E) Barrett*s esophagus
F) Heart failure (New York Heart association III-IV)
G) Coagulopathy (prothrombin time < 50% of control; partial
thromboplastin time > 50 seconds) or anticoagulant use that can not be
discontinued
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL16381.078.07 |