To prospectively validate the SERT scoring system for adenoma recurrence rates around the EMR scar after WF-EMR with SCAR technique applied to the defect margin.
ID
Source
Brief title
Condition
- Benign neoplasms gastrointestinal
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is the presence of residual/recurrence of polyp
tissue at or immediately surrounding the previous EMR site at follow up
colonoscopic procedures (at 18 months and 36 months) after WF-EMR involving the
SCAR technique of either SERT 0 lesions or SERT 1-4 lesions.
Secondary outcome
The secondary outcome measures are the following:
• Lesion characteristics and procedural characteristics of the initial EMR data
of SERT 0 and SERT 1-4, such as
- Location of the lesion
- Rate of *en bloc resection* (removing entire lesion in one snare) with
histologically confirmed clear margins
- The number of snare resections needed to achieve complete clearance
- Number of injections required for haemostasis
- Location of bleeding vessels
- Size/number of bleeding vessels
- Time required for EMR
- Frequency of adverse events, bleeding, perforation or readmission
- Need for surgery
- Evidence of malignancy
• The presence of residual/recurrence of polyp tissue at or immediately
surrounding the previous EMR site at follow up colonoscopic procedures at 6
months after WF-EMR involving the SCAR technique of SERT 1-4 lesions. .
• Histology and dysplasia of the residual/recurrence at or immediately
surrounding the previous EMR site detected at all follow up colonoscopic
procedures
• The frequency of malignant submucosal invasive disease present within the
residual/recurrence of polyp tissue at or immediately surrounding the previous
EMR site
• The frequency of the necessity to perform an additional surgical resection
due the impossibility to endoscopically resect residual/recurrence of polyp
tissue or due to malignant submucosal invasive disease at or immediately
surrounding the previous EMR site
Background summary
Colonoscopy and polypectomy reduces the anticipated incidence of colorectal
malignancy in patients with significant adenomatous polyps by approximately 80%
in long term follow up. Removal of flat colonic neoplasia 20mm in size or
larger is more complex and requires specific endoscopic techniques, one such
technique being termed wide field endoscopic mucosal resection (WF-EMR). This
procedure has been shown to be safe and effective at resecting lesions limited
to the mucosa, especially in combination with thermal treatment (Snare Tip Soft
Coagulation) of the EMR defect margin. This technique is also known as the SCAR
technique.
An important longer-term complication of EMR of large flat colonic neoplasia is
the phenomenon of residual polyp tissue or polyp recurrence, which is detected
by surveillance colonoscopies (SC). SC are performed at defined intervals after
the index procedure. Increasing evidence suggests that identifiable factors at
the initial EMR could predict recurrence at SC1[6]. Therefore a risk score for
recurrence after EMR known as the Sydney EMR Recurrence Tool (SERT) is
developed, which will be validated in this prospective cohort study.
Study objective
To prospectively validate the SERT scoring system for adenoma recurrence rates
around the EMR scar after WF-EMR with SCAR technique applied to the defect
margin.
Study design
Prospective multicenter cohort study to investigate the safety of triaging the
timing of follow up after colonic EMR based on the Sydney EMR Recurrence Tool.
Study burden and risks
Harm to the patient: SERT 1-4 patients are essentially receiving current
standard treatment and so no harm is expected. SERT 0 patients are undergoing
first surveillance colonoscopy at 18 months rather than 4-6 months. Therefore
there is a risk that a small remnant of adenomatous tissue grows during this
time, and that might causes harm to the patient before it is detected at the 18
months surveillance procedure. We expect only a very small risk that
recurrence has progressed to such an extent in 18 months that it is not
endoscopically treatable and requires surgery or that it might have developed
into cancer.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Patients referred for endoscopic removal of a large sessile colonic polyp sized bigger or are 20mm
Age >18 years
Able to give informed consent to involvement in trial
Exclusion criteria
-Lesion involving the ileocaecal valve
-Pregnancy: currently pregnant or attempting to become pregnant
-Lactation: currently breastfeeding
-Taken clopidogrel within 7 days
-Taken warfarin within 5 days
-Had full therapeutic dose unfractionated heparin within 6 hours
-Had full therapeutic dose low molecular weight heparin (LMWH) within 12 hours
-Known clotting disorder
-Previous attempt at EMR of the polyp referred for resection
-Known with or the endoscopic suspicion of the presence of hereditary polyposis, such as FAP, Lynch syndrome and serrated polyposis syndrome or bowel cancer syndrome
Design
Recruitment
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 | NCT02957058 |
| CCMO | NL61758.018.17 |