This study aims to assess the efficacy, safety and effectiveness of LumenR-assisted ESD for the treatment of large rectal adenomas. In addition, the learning curve for this technique in endoscopists with experience in standard ESD is assessed.
ID
Source
Brief title
Condition
- Benign neoplasms gastrointestinal
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Our main study parameter is the number of en bloc resections and the en bloc
resection rate after LumenR assisted ESD.
Secondary outcome
The following secondary parameters are designed to further study the efficacy
and safety of LumenR assisted ESD:
- Procedural time
- Number of patients with a histological R0-resection
- Adenoma recurrence rate at 6 months after the procedure
- Number of procedures with cessation of the ESD procedure due to
technical difficulties
- Number of intra procedural complications (bleeding or perforation) for which
an additional intervention, defined as transfusion, admission,
radiologic
intervention or surgical treatment is required.
- Number of patients with early (48 hours) and late (until 14 days) post
procedural complications for which additional treatment is necessary,
defined as presentation at the emergency ward, transfusion, admission,
repeat endoscopy, radiologic intervention or surgical treatment
Background summary
Endoscopic submucosal dissection (ESD) and endoscopic mucosal resection (EMR)
are both considered to be effective treatment strategies for large rectal
adenomas. ESD has the advantage of achieving en bloc resection with a lower
local recurrence rate compared to piecemeal endoscopic mucosal resection.
Furthermore, ESD reportedly has higher complications rates, prolonged
procedural times and endoscopists need to have profound training before they
can safely perform this procedure. Therefore a new endoscopic ESD overtube
(LumenR) is developed to overcome the technical difficulties associated with
ESD.
Study objective
This study aims to assess the efficacy, safety and effectiveness of
LumenR-assisted ESD for the treatment of large rectal adenomas. In addition,
the learning curve for this technique in endoscopists with experience in
standard ESD is assessed.
Study design
A multicentre pilot cohort study to investigate the efficacy and safety of
LumenR assisted ESD in patients with large rectal adenomas performed by
endoscopists with sufficient ESD experience.
Intervention
Eligible patients will receive LumenR-assisted ESD performed by an endoscopist
with sufficient ESD experience.
Study burden and risks
The patients will receive a colonoscopy with LumenR assisted ESD for the
endoscopic remorval of a known large rectal polyp. This device is not
associated with additional risks, but ESD itself is associated with a
relatively high procedure related bleeding and perforation rate. A benefit for
the patient is that he or she will receive endoscopic treatment of a large
rectal polyp which was historically removed with a surgical treatment. When
this adenoma polyp can be removed in an endoscopic fashion surgery can be
avoided and therefore its associated morbidity and mortality as well.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- The patient is diagnosed during a complete colonoscopy with a large non-pedunculated rectal adenoma (sessile or laterally spreading) with:
• Diameter of >= 20mm and <= 50mm (estimated at the discretion of the endoscopist or by an opened biopsy forceps/resection snare)
• Circumferential involvement of the rectal wall of <= 50 %
• The lower borders and upper borders of the adenoma are located between 1 cm and 15 cm from the dentate line
- If biopsies are taken at the primary diagnostic procedure, these are allowed to show benign intraepithelial (low or high grade) dysplasia. Biopsies are not a prerequisite for inclusion.
- ASA classification I-III
- Is aged of 18 years or older
- Signed the informed consent form
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Endoscopic suspicion for submucosal invasive cancer, with for example one of the following characteristics:
• Kudo pit pattern type V
• Excavated/depressed type morphology (Paris type 0-IIc or 0-III)
• Fold convergence
• Large smooth nodule > 1 cm in a flat lesion
- Histopathology or biopsy proven invasive or malignant disease
- The targeted lesion consists of residual polypoiïd tissue after previous (endoscopic) treatment of this lesion
- The patient is known with active inflammatory bowel disease (morbus Crohn or ulcerative colitis) of the colorectum.
- Patients with suspicion of polyposis syndrome
- Patients with a known irreversible coagulopathy, or patients with anticoagulational therapy (with warfarins, heparins, NOACS or double anti-platelet agents) for an indication wherefore temporarily cessation of the treatment is not possible.
- Patients with active bleeding from any source
- HIV-positive or immunocompromised patients
- Patients who receive chemotherapy
- Pregnant patient
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL56236.018.16 |