The aim of this study is to assess the safety and efficacy of the new CaptivatorTM EMR kit.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Phase I
1) Maximum diameter of the resection specimens retrieved with the Captivator
EMR - and Duette devices.
Phase II
1) Percentage of successful endoscopic resection (i.e. resection of all lesion
delineation markings)
Secondary outcome
Phase I
1) Difference in the number of device or procedure related complications, such
as bleeding or perforation, experienced with the CaptivatorTM device compared
to the DuetteTM device.
2) Visibility of the CaptivatorTM device and the DuetteTM device (pre- and
post-procedure).
3) Ease of endoscopic resection
4) Procedure time
Phase II
1) Number and severity of any acute (during procedure) or early (0-48 hours)
device or procedure related complications such as bleeding or perforation
during endoscopic resection with the CaptivatorTM device. Complications are
registered only if they are clinically significant.
2) Presence of any late complications (> 48 hours) such as bleeding or
perforation during endoscopic resection with the CaptivatorTM device.
Complications are registered only if they are clinically significant.
3) Procedure time
Background summary
Endoscopic resection (ER) is the core modality in endoscopic therapy for early
esophageal neoplastic lesions (i.e. high grade dysplasia [HGD] or early
carcinoma). Histopathological assessment of the resection specimen provides the
opportunity to select patients suitable for further endoscopic treatment with
additional ER or ablative therapy.
The ER-cap technique was the first widely used resection technique.1-3 However,
this procedure is technically demanding, particularly when multiple resections
(i.e. piecemeal) are required. A more user friendly alternative to the ER-cap
method is the multi-band mucosectomy (MBM) technique (DuetteTM, Cook, Limerick,
Ireland).4-7 This modification of a variceal band ligator comprises a control
handle mounted at the proximal end of the accessory channel, connected by a
trigger cord to a transparent cap with six rubber bands that is placed on the
tip of the endoscope. The target area is sucked into the cap without prior
submucosal injection, followed by the release of a rubber band and resection of
the created pseudopolyp by a hexagonal snare. This suck-band-snare procedure
may be repeated six times per MBM-kit.
In Barrett*s neoplasia MBM achieves comparable success rates for effective
piecemeal resection compared to the ER-cap technique. Furthermore,
complications rates (i.e. perforation or bleeding) are low, and MBM is quicker
and cheaper than ER-cap.8-10
Yet, the DuetteTM MBM system has some disadvantages. First, it provides a
reduced endoscopic visualisation due to the presence of the black rubber bands
on the distal attachment cap, which limit the circumferential visualization and
absorb most of the endoscopic light. Reduced visualisation may lead to
incomplete endoscopic resections and may hamper the management of complications
such as bleeding.
Secondly, the release strings of the DuetteTM system are relatively thick and
therefore further limit the endoscopic view. Furthermore, due to the fibrous
structure of the strings, they will absorb the mucous and blood suctioned
through the working channel of the endoscope during the procedure. As a result,
suction will become less powerful and passage of accessories through the
working channel alongside the release strings becomes more difficult.
Recently, a new MBM-device (CaptivatorTM EMR, Boston Scientific Corporation,
Natick, MA, USA) has been developed which may overcome the disadvantages of the
DuetteTM system by improved visualization, passage of accessories, and suction
power due to different trigger cords and cap.
Study objective
The aim of this study is to assess the safety and efficacy of the new
CaptivatorTM EMR kit.
Study design
This study will be executed in two phases. Phase I of this study is a
prospective randomized trial comparing the CaptivatorTM EMR and the DuetteTM
MBM device for which 3-6 patients will be included; phase II is a prospective
pilot series with the CaptivatorTM EMR for which 5 consecutive patients will be
included.
The study will be performed in a single centre, tertiary referral centre
(Academic Medical Centre, Amsterdam, The Netherlands) for the endoscopic
treatment of early esophgeal neoplasia.
The aim is to perform both phases in the 6-9 months after approval of the IRB.
Intervention
Endoscopic resection with the CaptivatorTM device.
Study burden and risks
Phase I: Studypatients will be sedated 20-30 minutes longer compared to
patients who do not participate in this study. the additional risk with
participation is therefor related to the longer sedation time. Patients will
not be exposed to significant device associated complications because all the
study patients will directly undergo an esophagectomy after the ER procedure.
Phase II: patients will undergo a MBM procedure. Since the new CaptivatorTM EMR
device is very similar to the current DuetteTM device and the CaptivatorTM
device is basically a combination of two well-know devices that have been
profen safe. Therefor, no additional risks for the MBM procedure are expected.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Phase I
1. Age 18-80 years
2. Subject is scheduled for esophagectomy
3. Subject is willing to participate, fully understands the content of the informed consent form, and signs the informed consent form.;Phase II
1. Age 18-80 years
2. Barrett esophagus with a visible abnormality and biopsy-proven high grade dysplasia and/or early cancer
3. Lesion with a maximum size of 4 cm in longitudinal length and 50% of the circumference.
4. No suspicion of submucosal invasion, based on the macroscopic appearance and/or endosonography
5. No signs of lymph node and/or distant metastasis on endosonography and CT-scanning of the thorax and abdomen.
6. Patient is scheduled for endoscopic resection of present BE neoplasia
7. Subject is willing to participate, fully understands the content of the informed consent form, and signs the informed consent form.
Exclusion criteria
Phase I
1. Subject has previously undergone endoscopic therapy in the intended treatment zone, including (but not limited to) cryospray therapy, laser treatment, photodynamic therapy, endoscopic mucosal resection, radiofrequency ablation or argon plasma coagulation.
2. Presence of esophageal stenosis limiting access to the intended treatment zone.
3. Scarring by other causes of the intended treatment zone.
4. Subject refuses or is not able to provide written informed consent.;Phase II
1. Subject has previously undergone endoscopic therapy in the intended treatment zone, including (but not limited to) cryospray therapy, laser treatment, photodynamic therapy, endoscopic mucosal resection, radiofrequency ablation or argon plasma coagulation.
2. Presence of esophageal stenosis limiting access to the intended treatment zone.
3. Scarring by any cause of the intended treatment zone.
4. Subject refuses or is not able to provide written 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 | NL48527.018.15 |