To compare oesophageal motility as well as refluxcharacteristics before and after endoscopic treatment of the Barrett segment, and to study differences between patients treated with SRER or BÂRRx.
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Using oesophageal manometry the following parameters will be assessed: % of
contractions that are peristaltic, contraction amplitude and duration in the
proximal and distal oesophagus, lower oesophageal sphincter pressure and
relaxation nadir pressure. Impedance-pH measurements will be analyzed for
number and type (acid, weakly acidic, liquid, gas or mixed liquid-gas reflux)
of reflux episodes and proximal extent of the reflux episodes. In addition, %
of time with oesophageal pH<4.0 will be determined.
Secondary outcome
-
Background summary
Endoscopic surveillance is recommended for patients with Barrett*s oesophagus
because of its malignant potential and the hope to detect dysplasia before it
progresses to adenocarcinoma. Oesophagectomy has traditionally been recommended
for patients with high-grade dysplasia. Oesophageactomy is an operation with
considerable mortality and morbidity. Recently, several less invasive
endoscopic treatments have been developed. Two of these techniques are stepwise
radical endoscopic resection (SRER) and BÂRRx. Little is known about
oesophageal motility and reflux characteristics after endoscopic treatment with
SRER and BÂRRx
Study objective
To compare oesophageal motility as well as refluxcharacteristics before and
after endoscopic treatment of the Barrett segment, and to study differences
between patients treated with SRER or BÂRRx.
Study design
Patients will undergo routine oesophageal manometry and ambulatory 24-hr
impedance-pH monitoring twice, one measurement before and one measurement after
endoscopic treatment.
Study burden and risks
Oesophageal manometry and the 24-hr reflux monitoring test after patients have
stopped their medication are routine clinical practice at our department for
patients with therapy-resistant reflux symptoms. Oesophageal manometry and
impedance-pH reflux monitoring tests are CE registered and are widely used in
daily practice.
For this study patients will undergo a second oesophageal manometry and 24-hr
reflux monitoring after endoscopic treatment for their high-grade dysplasia.
These second manometry and impedance-pH measurement are not indicated for
routine clinical testing and are required to study the effect of the treatment
on oesophageal motility and reflux. There is no direct advantage for the
patients to participate.
Koekoekslaan 1
3430 EM Nieuwegein
Nederland
Koekoekslaan 1
3430 EM Nieuwegein
Nederland
Listed location countries
Age
Inclusion criteria
Barrett's oesophagus with high-grade dysplasia
Scheduled for endoscopic treatment with SRER or BARRx
Exclusion criteria
Prior surgery of the stomach or oesophagus
condition with contraindicates the cessation of PPI therapy such as peptic ulcer disease
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 | NL14589.100.06 |