To assess the performance of the EndoRotor, as compared to conventional endoscopic techniques, for direct endoscopic necrosectomy (DEN) of walled off necrosis (WON)
ID
Source
Brief title
Condition
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint: Mean total necrosectomy time to achieve resolution of WON.
Necrosectomy time is measured in minutes from the start of the debridement
procedure to completion of the debridement procedure, including time to swap
devices, and comprises the summation of the individual necrosectomy times in
case of multiple procedures.
a. Resolution is defined as clinical improvement of WON symptoms precluding
the need for additional endoscopic or surgical interventions.
d. Clinical improvement is defined according to the criteria used in the PANTER
trial and TENSION trial.8,15 *Clinical improvement* was defined as:
i. Improved function of at least two organ systems (i.e. circulatory,
pulmonary, renal) according to the Investigator*s medical judgement within 72
hours of the procedure, or;
ii. At least 10% improvement of two out of three parameters of infection
(i.e. C-reactive protein, leucocyte count or temperature) within 72 hours of
the procedure.
Deterioration of these parameters by other infectious causes (e.g. urinary
tract infection) were excluded. Clinical failure was defined as the absence of
clinical improvement or clinical deterioration.
Secondary outcome
The following secondary endpoints will be summarized using descriptive
statistics. Any testing done to compare EndoRotor to conventional DEN will be
considered hypothesis generating in nature.
1. The occurrence of all adverse events measured from the Index Procedure
through the 6 Month Post Necrosectomy Follow-up Visit.
2. Conversion of DEN to surgery.
3. Length of hospitalization measured in days from the Index Procedure,
including days in intensive care unit (ICU) vs. standard in-patient
hospitalization.
4. Mean total cost of care per subject including: procedure costs, debridement
devices used during the procedure, and inpatient hospital stay from the date of
procedure to the date of discharge based on reimbursement fee structure
expressed in US dollars, Euros or UK Pounds respectively.
a. Procedure costs will be based on the cost of an endoscopic retrograde
cholangiopancreatography (ERCP) which covers room, X-ray, sedation, personnel,
and other materials.
5. Percent reduction in WON collection volume (cm3) as assessed by contrast
enhanced computed tomography (CECT) scan or magnetic resonance imaging (MRI)
(Baseline vs. completion of necrosectomy).
a. Endoscopic ultrasound (EUS) may be used for imaging only when a subject is
contraindicated for MRI and CECT.
b. WON collection volume will be measured as follows:
i. Length = longest diameter in cm/mm in the axial plane (left - right)
ii. Width = the longest diameter in cm/mm (frontal - dorsal) in the same axial
plane as the length, perpendicular on the longitudinal axis.
iii. Height = longest diameter in cm/mm on coronal plane (cranial - caudal)
6. Procedure time measured in minutes from the point of per-oral scope
insertion to scope removal (scope-in / scope-out).
7.Total number of procedures required to achieve resolution of WON. Resolution
is defined using the definition in the primary endpoint.
8. Subject quality of life (QOL) as assessed by a SF-36 questionnaire performed
at Baseline, Discharge, and at the 1, 3, and 6 Month Post Necrosectomy
Follow-up Visits.
9. Device deficiencies defined as an inadequacy of a medical device with
respect to its identity, quality, durability, reliability, safety, or
performance including malfunctions, use errors, and inadequate labelling.
Background summary
Acute pancreatitis is a sudden inflammation of the pancreas. Although the cause
of acute pancreatitis can vary widely between patients, severe cases can lead
to the development of life-threatening complications. One of these
complications is the development of infected necrotizing pancreatitis, in which
part of the pancreas (pancreas) dies (necrosis) and this necrosis becomes
infected (infecting). In walled-off pancreatic necrosis, the dead tissue must
be removed by means of an operation, an "endoscopic necrosectomy". To remove
the necrosis, instruments that have not been specifically developed for this
purpose are currently used (conventional instruments). Although it is almost
always possible to remove the necrosis, the procedure often takes a long time
and must be repeated several times. For this reason, we have long been looking
for new instruments that facilitate the removal of dead tissue from the fluid
collection and make it more effective.
The EndoRotor® (Interscope Medical, Inc., Whitinsville Massachusetts, USA) is a
new automated mechanical endoscopic medical device designed for use in the
gastrointestinal tract for tissue removal. Using the EndoRotor®, a motorized,
rotating cutting tool, small pieces of tissue are cut, suctioned, and removed
step by step.
In an earlier study, conducted at Erasmus MC in 2018, the EndoRotor® was used
to treat patients with necrotizing pancreatitis. This study showed that the
dead tissue could be removed with fewer treatments and that the patients
recovered quickly after treatment with the EndoRotor®.
In a second study, conducted in 2019 at Erasmus MC and in various hospitals in
the United States, a larger group of patients was treated with the EndoRotor®.
This research also showed that the dead tissue could be removed safely and with
fewer treatments. This indicated that the good results of the first study could
also be achieved in other centers.
This new study is being conducted to directly compare the EndoRotor® system
(the examination tool) with current conventional instruments for removing dead
tissue in patients with walled-off pancreatic necrosis. The EndoRotor® system
is expected to require fewer interventions than conventional instruments to
remove dead tissue in the walled-off necrosis. In this current study, the
subjects will be divided into two groups: one-half of the subjects (30
subjects) will be treated with the EndoRotor®, the other half of the subjects
(30 subjects) will be treated with the conventional instruments. This allows us
to directly compare the outcomes of the treatment and this is important before
recommending this technique with the EndoRotor® even more widely to fellow
doctors around the world as a safe and effective method for removing necrosis
in patients with acute pancreatitis.
Study objective
To assess the performance of the EndoRotor, as compared to conventional
endoscopic techniques, for direct endoscopic necrosectomy (DEN) of walled off
necrosis (WON)
Study design
This study is a prospective, post-market, multicenter, randomized controlled
trial to assess the performance of the EndoRotor, as compared to conventional
endoscopic techniques, for direct endoscopic necrosectomy (DEN) of walled off
necrosis (WON).
A total of 60 subjects will be enrolled for this study.
Thirty subjects will be randomized to the EndoRotor arm (*study device*), and
30 will be randomized to the conventional DEN arm (*control device*). Subjects
will be enrolled at 10-20 sites in the United States (US), United Kingdom (UK),
The Netherlands, France, Italy, and Germany. It is anticipated that each site
will enroll up to 10 subjects over a period of 9 months.
Each subject will be part of the study for approximately 7 months. The entire
study is estimated to last approximately 16 months, including 9 months of
enrollment plus 7 months of follow-up from the time the last subject is
enrolled.
Intervention
2 days following the placement of EUS Guided Drainage and determination, if the
study subject meets the I/E criteria, a direct endoscopic necrosectomy
procedure can occur. Subjects will be randomized in a 1:1 ratio to the
EndoRotor System or conventional DEN.
- Subjects randomized to the study device arm will undergo DEN using the 5.0 mm
EndoRotor Catheter as per the system Instructions for Use (IFU).
Ideally, the entire EndoRotor procedure will be completed using the 5.0 mm
catheter; however, if the procedure cannot be completed using the 5.0
mm catheter the 3.2 mm EndoRotor Catheter may be used. The reason for using
the 3.2 mm catheter will be recorded on the applicable CRF.
Although the EndoRotor system will primarily be used to conduct the DEN
procedure, conventional DEN instruments will be allowed to complete the
procedure only if the Investigator is unable to do so with EndoRotor alone.
The type of conventional DEN instrument and reason for use will be
captured on the applicable CRF.
- Subjects randomized to the control device arm will undergo conventional DEN
as per the SOC. Investigators will choose conventional DEN
instruments according to their preference.
Study burden and risks
The EnoRotor procedure poses no new risks to the patient than the commonly used
mucosal resection techniques, As with all endoscopic resection devices, the
most common risks are associated with the EndoRotor device or procedure include
but are not limited to:
* Stent dislodgement
* Bleeding
* Delayed bleeding
* Perforation
* Pneumoperitoneum
* Infection
* Tissue damage
In addition to the risks listed above, the risks related to endoscopy and
anesthesia should be explained to the subject.
All efforts will be made to minimize these potential risks by implementing Risk
Minimization Actions which are:
* Selection of qualified Investigators and qualified investigational centers;
* Training the Investigators on proper technique for the EndoRotor System;
* Training the Investigators and on adherence to the study protocol and system
IFU;
* Observation of procedures by the Interscope, Inc. and/or clinical personnel,
as needed;
* Defining clear inclusion/exclusion criteria that ensure only appropriate
subjects are enrolled and treated;
* Scheduled monitoring visits to the investigational site; and
* Regular communication with Investigator(s) and staff.
Each subject will be part of the study for approximately 7 months. The entire
study is estimated to last approximately 16 months, including 9 months of
enrollment plus 7 months of follow-up from the time the last subject is
enrolled.
The patient will have to be available for the following:
* Informed Consent Process
* Baseline Visit
* EndoRotor Procedure or Conventional DEN Procedure
* Hospitalization
* During the Hospitalization Period subjects may require additional DEN
procedures for treatment of WON. For both study arms, subjects will be assessed
at 72 hours post necrosectomy to see if additional procedures are required.
* Discharge
* 1 Month Post Necrosectomy Follow-up Visit
* 3 Months Post Necrosectomy Follow-up Visit
* 6 Months Post Necrosectomy Follow-up Visit
Dr.Molewaterplein 40 40
Rotterdam 3015 GD
NL
Dr.Molewaterplein 40 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
1. Patients 18 years of age or greater.
2. Patients with symptomatic pancreatic necrosis due to acute pancreatitis that
have an indication to
undergo endoscopic necrosectomy after having undergone EUS-guided drainage.
a. Stent must be in place for a minimum of 2 days prior to the DEN
procedure.
3. Patients who can tolerate repeat endoscopic procedures.
4. Subjects with the ability to understand the requirements of the study, who
have provided written
informed consent, and who are willing and able to return for the required
follow-up assessments.
5. ASA classification < 5.
Exclusion criteria
1. Documented pseudoaneurysm > 1 cm within the WON.
2. Subject unable or unwilling to provide informed consent.
3. Intervening gastric varices or unavoidable blood vessels within the WON
access tract (visible using
endoscopy or endoscopic ultrasound).
4. Coagulation disorders or anti-coagulant therapy which cannot be discontinued
(aspirin allowed).
5. Any condition that in the opinion of the Investigator would create an unsafe
clinical situation or stent placement that would not allow the patient to
safely undergo an endoscopic procedure.
6. Pregnant or lactating women or women of childbearing potential who do not
employ a reliable method of
contraception as judged by the Investigator, and/or are not willing to use
reliable contraception for the
duration of study participation.
7. Patient is enrolled in another trial that could interfere with the endpoint
analyses of this trial.
8. Prior necrosectomy on existing collection.
9. Greater than 2 pancreatic / extra-pancreatic fluid collections.
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 |
|---|---|
| ClinicalTrials.gov | NCT03694210 |
| CCMO | NL75188.078.20 |