To evaluate the efficacy and safety of the Focal C2 CryoBalloon* Ablation System (FCBAS) for the treatment of Barrett*s epithelium.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is efficacy, defined as:
- Complete eradication of intestinal metaplasia (CE-IM): the percentage of
patients with complete eradication of all Barrett*s epithelium on endoscopy AND
CE-IM in all biopsies obtained at the first follow-up endoscopy after the
maximum of 5 treatment sessions (and escape treatments if necessary).
- Complete eradication of dysplasia (CE-D): the percentage of patients with
CE-D in all biopsies obtained at the first follow-up endoscopy after the
maximum of 5 treatment sessions (and escape treatment if necessary).
Secondary outcome
- Safety: Incidence of FCBAS related serious adverse events
- CE-IM stratified by baseline stratum (treatment naïve, post-EMR) and baseline
dysplasia grade (LGD, HGD, EAC).
- CE-D stratified by baseline stratum (treatment naïve, post-EMR) and baseline
dysplasia grade (LGD, HGD, EAC).
- Number of CBA treatments required to achieve CE-IM and/or CE-D.
- Percentage of patients requiring escape treatment (EMR, APC) during study
participation in order to achieve CE-IM and/or CE-D.
- Percentage of patients with progression to LGD, HGD or cancer at first
follow-up endoscopy.
- Incidence of all (non-treatment related) serious adverse events
- Incidence of treatment-related adverse events: for the definition of
treatment-related adverse events and classification please see section 8.2.1 of
the protocol.
- Post-procedural pain in the area of CBA treatment scored on a 0-10 point
numeric rating scale (NRS) for pain, registered daily during 2 weeks in a
patient diary (electronic or paper, depending on the wishes of the patient).
- Post-procedural dysphagia on a validated scale from 0-4, registered daily
during 2 weeks in a patient diary (electronic or paper, depending on the wishes
of the patient).
- Usage of analgesics after treatment: registered daily during 2 weeks in a
patient diary (electronic or paper, depending on the wishes of the patient).
- Technical success, defined as the percentage of treatment sessions considered
complete, which is defined as treatment of all visible BE as intended by the
endoscopist.
- The percentage of treatment sessions with device malfunctions (device
malfunction is defined as problems with the device or a part of the device that
require (partially) device replacement.
- Satisfaction score as given by the endoscopist directly after the treatment
session (range 1-10, with 1 being the lowest score, 10 the highest).
- Durability of complete eradication of intestinal metaplasia and dysplasia
during follow-up: defined as the recurrence of intestinal metaplasia or
dysplasia during follow-up.
Background summary
Cryotherapy has been used for years to eradicate flat dysplastic Barrett*s
esophagus (BE). It preserves the extracellular matrix and may be better
tolerated and might result in lower stricture rates when compared to other
ablation techniques, without compromising on efficacy. C2 CryoBalloon Ablation
(CBA) is a relatively new method for application of cryotherapy. Previous
studies with limited number of patients have shown promising results.
Study objective
To evaluate the efficacy and safety of the Focal C2 CryoBalloon* Ablation
System (FCBAS) for the treatment of Barrett*s epithelium.
Study design
European, multicenter, prospective, single arm, non-randomized intervention
study
Intervention
Focal CBA therapy until complete eradication of intestinal metaplasia (CE-IM)
is established, with a maximum of 5 subsequent CBA treatment sessions per
patient. Escape treatment may be performed: for lesions <5mm a maximum of 2
argon plasma coagulation (APC) treatment sessions, and for lesions of >5mm
single endoscopic mucosal resection (EMR).
Study burden and risks
The nature and extent of the burden and risks associated with study
participation are minimal. There are multiple treatment sessions included in
the study protocol, but these replace treatment sessions that patients would
have received had they been treated according to site standard of care. FCBA
has been shown to be effective and safe in previous studies and therefore it is
not anticipated that patients will require more treatment sessions or be
exposed to a higher complication risk. On the contrary, CBA is thought to
preserve the extracellular matrix, which may result in less pain and lower
stricture rates and therefore better patient tolerability. Extra activities for
patients include: 1) filling out a short questionnaire on symptoms, daily for 2
weeks after every endoscopic treatment session; 2) Phone contact 7 days after
every treatment session to evaluate symptoms and adverse events.
Koekoekslaan 1
Nieuwegein 3435CM
NL
Koekoekslaan 1
Nieuwegein 3435CM
NL
Listed location countries
Age
Inclusion criteria
1. Indicated for ablation therapy of Barrett*s epithelium, determined by:
o Histopathologically-confirmed LGD or HGD in flat-type BE with four quadrant
biopsies of every 2cm of the BE segment in the last 6 months, or
o Residual flat BE (with or without dysplasia) after endoscopic resection of a
focal lesion (by means of EMR or ESD) of non-flat BE, at least 6 weeks prior to
enrolling the patient to this study. The histopathologic evaluation of the
resected specimen should indicate endoscopic treatment (i.e., no more than only
superficial submucosal invasion (<=T1sm1/<500 microns), absence of
lymphovascular invasion, not poorly differentiated, free deep (vertical)
resection margins).
NB: In case of performed endoscopic resection, the absence of residual cancer
in the remaining Barrett*s epithelium should be confirmed with random biopsies
(these biopsies might be taken during the same endoscopy, but a maximum
interval of 6 months is allowed between these biopsies).
2. Ablation naïve (no previous ablation therapy of the esophagus)
3. Prague Classification <=C2 / <=M5 (including BE tongues, excluding small BE
islands, in case of endoscopic resection the Prague Classification AFTER
endoscopic resection)
4. Older than 18 years of age at time of consent
5. Operable per institution*s standards
6. Informed consent
Exclusion criteria
1. Esophageal stenosis preventing advancement of a therapeutic endoscope
2. Prior endoscopic resection (EMR or ESD) >2cm in length AND/OR >50% of the
esophageal circumference
3. Prior distal oesophagectomy
4. Active oesophagitis grade B or higher (patients can be included after
appropriate treatment of reflux oesophagitis)
5. History of oesophageal varices
6. Achalasia
7. Severe medical comorbidities precluding endoscopy
8. Uncontrolled coagulopathy
9. Pregnant or planning to become pregnant during period of study participation
10. Life expectancy <=2 years, as judged by the site investigator
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
In other registers
| Register | ID |
|---|---|
| Other | NL 7253 |
| CCMO | NL64555.100.18 |
| OMON | NL-OMON25207 |