The aim of the study is to assess the efficacy and safety of the self-sizing RFA ballon for eradication of Barrett's mucosa with low-grade, high-grade and early neoplasia
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) Percentage of endoscopically visual surface regression of BE epithelium at 3
months, as scored by two independent endoscopists.
Secondary outcome
1) Number of Adverse events:
The number of patients who reported acute (periprocedural), early (<48 hrs) or
late (>48 hrs) complications.
2) Duration and acceptability of the ablation procedure:
Time of first introduction of the endoscope, time of the first introduction of
the Self-sizer balloon and the time of final removal of the Self-sizer balloon
are recorded during the endoscopy.
Background summary
Radiofrequency ablation is an established endoscopic technique for eradication
of Barrett*s esophagus which has been investigated in a variety of study
designs (including two randomized trials), and settings (US and EU, tertiary
academic centers, community referral centers).9-13 Radiofrequency ablation is
associated with an acceptable safety profile, high rates of complete
eradication of dysplasia and intestinal metaplasia, durability of effect, and a
significant relative risk reduction for neoplastic progression.9-13 As a
result, radiofrequency ablation is considered standard of care for patients
with high-grade dysplasia, as well as for residual Barrett tissue after
endoscopic resection of early cancer.14
Currently, most patients undergo primary circumferential ablation with a
balloon based electrode, the Barrx360 System, followed by additional focal
ablation using a cap-based electrode, the Barrx90 System. The Barrx360
procedure starts with the introduction of a sizing balloon to measure the
internal esophageal diameter, because the ablation balloon comes in different
sizes (18-31mm). The sizing balloon is used to take multiple measurements of
the esophageal diameter and assists the endoscopist in choosing an ablation
catheter with the appropriate diameter. Subsequently, the sizing balloon is
removed and the BE segment can be treated with one of the five sizes of the
ablation balloon. The advised standard treatment regimen for Barrx360
procedures consists of two ablation runs with extensive cleaning of the
ablation zone after the first ablation (1x-clean-1x). The entire treatment
procedure is time-consuming, as it consists of many different steps and
requires multiple introductions and removals of the endoscope, sizing catheters
and ablation balloons which are impractical and uncomfortable to the patient.
By incorporating the sizing balloon and the Barrx360 ablation balloon into a
single device, the use of a separate sizing balloon and the need for having
multiple sized balloon catheters are eliminated. The new Self Sizing RFA
balloon catheter is a circumferential balloon catheter, and consists of a 4cm
long bipolar electrode that is furled around a balloon. This single balloon
catheter can unfurl in size ranges including 18-31mm, making it possible to
size and treat the BE segment in a single step.
The current study is designed as an uncontrolled feasibility study using the
Self Sizing RFA balloon for circumferential ablation of Barrett*s esophagus
with early neoplasia.
Study objective
The aim of the study is to assess the efficacy and safety of the self-sizing
RFA ballon for eradication of Barrett's mucosa with low-grade, high-grade and
early neoplasia
Study design
Enrollment
Thirty patients will be enrolled in this study. If a patient is eligible for
the study after the mapping endoscopy, and/or after endoscopic resection, and
no abnormalities (visible lesions and/or severe stenosis) are observed during
the endoscopy, the patient will undergo treatment with the Self Sizing RFA
Balloon catheter treatment using the standard protocol .
4.4 Endoscopic resection at baseline
For patients with a visible abnormality mandatory endoscopic resection is
performed. In case there is no suspicion on submucosal infiltration of the
lesion the choice of ER technique will be left to the discretion of the
endoscopist, with a preference for the ER-cap technique or endoscopic
submucosal dissection (ESD) for type 0-Is lesions and the multi-band
mucosectomy (MBM) technique for type 0-II lesions. In case of suspicion on
submucosal infiltration, the resection is preferably performed using the ER-cap
or the ESD technique, since this will result in a larger and deeper resection
specimen than with the MBM technique.
Prior to the ER procedure, the extent of columnar lined esophagus is documented
according to the Prague C&M classification.15
During the ER procedure, biopsies from the remaining Barrett*s segment (4Q/2cm)
will be obtained immediately after the endoscopic resection, to evaluate the
histological status of the remaining mucosa and to exclude the presence of
cancer. If complete endoscopic resection of all visible abnormalities has been
achieved during the ER procedure and the biopsies from the residual Barrett*s
segment, as obtained immediately after the ER, do not show invasive cancer the
patient is eligible for RFA.
4.5 Ablation procedure
4.5.1 Inspection of the Barrett*s segment
The esophagus is evaluated using white light high-resolution endoscopy (WLE)
and narrow band imaging (NBI). The extent of columnar lined esophagus is
documented according to the Prague C&M classification [ref] and by taking still
images with WLE+NBI at 1 cm intervals. In the absence of visible abnormalities
and no severe stenosis, patients will be eligible for circumferential ablation
with the Self Sizing RFA balloon using the standard ablation regimen.
4.5.2 Standard ablation regimen
After mapping, the Barrett*s segment is flushed with the mucolytic agent
acetylcysteine (1%) followed by flushing with tap water. The Self Sizing RFA
balloon (GI Solutions Covidien, Sunnyvale, CA) is then introduced and
positioned at the desired treatment zone. The device is inflated, and the
electrode unfurls until the electrode contacts the esophageal wall. Under
visual control the BE is ablated (12 J/cm2 at 230 Watt) working proximal to
distal using visual repositioning. A small overlap (i.e. <1cm) between ablation
zones is allowed. After the first ablation pass, the endoscope is removed
followed by removal of the ablation catheter. The coagulum is cleaned off the
balloon catheter. The endoscope is reintroduced to irrigate and suction the
ablation zone. A distal attachment cap may be attached to the tip of the
endoscope to gently wipe of the coagulum from the ablated segment. After
irrigating and suctioning the debris away as much as possible, the ablation
zone is cleaned by forcefully flushing water through a spraying catheter. The
stomach is emptied and deflated, the endoscope is removed and the ablation
catheter is reintroduced to repeat the ablation. After this second ablation no
additional cleaning of the ablation zone is required. First, the endoscope is
removed, followed by careful removal of the ablation catheter.
4.6 Medication and discharge regimen
All patients will be on a maintenance dose of a proton pump inhibitor (by
preference esomeprazole) at a dosage of 40 mg twice a day during the whole
treatment period and follow-up. This medication is supplemented with ranitidine
300 mg at bedtime and sucralfate suspension four times a day (after each meal
and prior to bedtime) for a period of two weeks following all RFA procedures.
4.7 Follow-up
At 3 months, the first post-treatment endoscopy will be performed with WL high
resolution endoscopy and NBI. Still images with WLE+NBI will be obtained at
1-cm intervals throughout the extent of the original Barrett*s segment, to
assess the percentage of endoscopically visible surface regression of BE
(3.10.1), and any visible adverse events. Further treatment and follow-up are
performed according to standard guidelines. After complete removal of BE is
achieved, patients will be scheduled for surveillance endoscopy after six
months, twelve months and annually thereafter with WLE plus NBI and 4-quadrant
biopsies from the gastric cardia (immediately below the neosquamocolumnar
junction), off protocol.
Intervention
Radiofrequnecy ablation to eradicate barrett's mucosa
Study burden and risks
The ablation procedure with the self-sizing balloon will be less complicated,
because sizing of the inner esophagus is not performed as done in the RFA
procedure according the general guidelines. This will shorten the procedure
and less number of introductions of the gastroscope.
During the procedure with the self-sizing balloon, accurate imaging before and
after the ablation will increase the procedure time.
Overall, the procedure time will be more or less the same as the regular
balloon-based ablation.
The self-zing balloon has the same pressure (4 psi) and the same
radiofrequency energy (12j/cm2). We expect no additional risk for patients
participating in the study more than patients undergoing the regular ablation.
Oakmead Parkway 540
Sunnyvale CA 94085 CA
US
Oakmead Parkway 540
Sunnyvale CA 94085 CA
US
Listed location countries
Age
Inclusion criteria
1. Patients aged 18-85 years, with biopsy proven LGD, HGD or EC in a BE confirmed after expert pathology review.
2. Scheduled circumferential ablation for BE with flat HGD, or for BE after prior endoscopic resection (ER) for lesions containing HGD or EC (<2 cm and <50% of the circumference).
3. Pretreatment biopsies and/or ER specimens reviewed by a local expert pathologist.
4. Written informed consent.
Exclusion criteria
1. Patients with a BE segment < 2cm or >10 cm prior to ER.
2. Any prior endoscopic ablation treatment.
3. Significant esophageal stenosis prior to initial treatment, preventing passage of a therapeutic endoscope OR any prior endoscopic dilatation for esophageal stenosis.
4. Presence of esophageal varices.
5. Anti-coagulant therapy (apart from aspirin or NSAID) that cannot be discontinued prior to ER or RFA, OR uncorrectable hemostatic disorders.
6. In case of prior ER: patients with ER of multiple lesions in a single ER session are not eligible, if one of the resections measures more than the aforementioned size criteria, OR if resections of different lesions are not separated by a free circumferential segment of at least 1 cm.
7. In case of prior ER: a specimen showing carcinoma with positive vertical resection margins, deep submucosal invasion (>T1sm1), poorly or undifferentiated cancer (G3 or G4), or lymphatic/vascular invasion.
8. In case of prior ER: invasive cancer in any of the biopsies obtained at high-resolution endoscopy after ER.
9. An interval >6 months between the last high-resolution endoscopy with biopsies and RFA. An interval < 6 weeks between ER and RFA.
10. Patients unable to give informed consent.
Design
Recruitment
Medical products/devices used
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 | NL49843.018.14 |