Ignite Creation Date:
2024-05-06 @ 10:36 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03309683
Status:
COMPLETED
Last Update Posted:
2023-03-30
First Post:
2017-10-09
Brief Title:
Clip Placement Following Colonic Endoscopic Mucosal Resection EMR
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Clip Placement Following Colonic Endoscopic Mucosal Resection EMR The CLIPPER Study A Nationwide Multi-center Randomized Clinical Trail
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLIPPER
Brief 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
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
Detailed 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 ANDOR 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 ie 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 Patients 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 bleedingpossibleperforation 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
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 ANDOR 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 ie 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 Patients 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 bleedingpossibleperforation 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None