Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03309683 |
| Other study ID # |
R0003871 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 5, 2018 |
| Est. completion date |
March 1, 2023 |
Study information
| Verified date |
December 2021 |
| Source |
Radboud University Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Study design: A national, multi-center, patient-blinded, randomized clinical trial.
Study population: Patients undergoing EMR with a moderate to severe risk (right sided colon,
≥2cm) of developing Delayed Bleeding (DB).
Intervention: PC will be compared to standard care (no PC).
Main study endpoints: Primary endpoint is the incidence of DB. Secondary endpoints are
cost-effectiveness, quality of life and (severe) adverse events related to PC, adenoma
recurrence and risk factors for DB.
Description:
Design
This is a multi-center, randomized, patient-blinded multicenter trial, comparing two
treatment strategies in 356 patients undergoing EMR for a colonic lesion 2-6 cm. The study
will be enrolled in a selection of academic and non-academic Dutch hospitals. Patients
undergoing an EMR will be a randomly allocated by web-based randomization to:
A) PC treatment group: minimally 1 clip per 1 cm of the polyp resection plane: OR B) Control
group: standard care: only clip placement in case of uncontrollable bleeding (not
successfully managed by coagulation) AND/OR perforation.
Population The target population in this proposal includes patients of 18 years and older,
who gave written informed consent, undergoing EMR of a colonic polyp with a moderate to
severe risk of developing DB. Moderate-severe risk of DB is defined as a laterally spreading
or sessile polyp morphology proximal to the splenic flexure, measuring 2-6cm. Given the
significantly increased risk of bleeding in the cecum, ascending and transverse colon, clip
placement at this location may have the greatest benefit.
Inclusion Gastroenterologists from participating hospitals of the Dutch EMR Study Group will
be asked to recruit patients for the trial. They will provide written information about the
trial to potential participants, i.e., all patients scheduled for an EMR of a (right-sided)
colonic polyp 2-6 cm, and 18 years or older. Members of the study group will contact
potentially eligible patients at the outpatient clinic, hospital wards or by phone and give
detailed information about the trial. In- and exclusion criteria will be checked and
questions about the trial will be answered. Eligible patients will be invited to participate.
After both the patient and the study physician or nurse practitioner have signed the informed
consent form, in- and exclusion criteria will be checked again and baseline measurements will
be performed, which include disease specific questionnaires including risk-factors for DB (AC
use, restarting AC, polyp size, visible vessel, etc) and generic and disease specific quality
of life questionnaires (see below). Patient's contact details will be provided to the study
center for randomization.
Standard of care (usual care) In Dutch common practice, PC is not standard of care. PC is
used, based on the personal preference of the endoscopist, mostly in case of intra-procedural
bleeding/(possible)perforation. In our study group the minority of endoscopists applies PC
after EMR in case of high risk patients, defined as right-sided flat polyps of at least 2cm
and on AC or AP therapy.
Definition clinical significant delayed bleeding (DB)
DB is defined as any bleeding occurring after the completion of the procedure necessitating
blood transfusion, hospitalization, or re-intervention (either repeat endoscopy, angiography,
or surgery). Self-limiting bleeding managed on an outpatient basis is not included. Severity
of DB Severity of bleeding is defined according to the ASGE working party document for
adverse events in colonoscopy:
1. Mild DB: any post-EMR medical consultation, unplanned hospital admission, or
prolongation of hospital stays for 3 days or fewer.
2. Moderate DB: unplanned hospital admission of 4 to 10 days, transfusion, repeat
endoscopy, any interventional radiology procedure, or intensive care unit (ICU)
admission for 1 night.
3. Severe DB: admission to the ICU for more than 1 night, unplanned admission for more than
10 nights, surgery, or permanent disability.
Treatment of DB DB is primarily treated by resuscitation. In case of resuscitation failure,
colonoscopy, angiography with coiling and eventually surgery may be applied to control the
bleeding site.
Follow-up After the EMR patients are contacted at 30, 90 and 180 days (short-term and
long-term effects). At 180 days a colonoscopy is scheduled to access the adenoma recurrence
rate (standard of care).
