Polyp, ColonicCLIPPERNCT03309683
Clip Placement Following Colonic Endoscopic Mucosal Resection (EMR)
A study testing Olympus Quick Clip Pro - Single Use Repositionable Clips in people with Polyp, Colonic and Bleeding, run by Radboud University Medical Center at 2 sites in Netherlands.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polyp, Colonic, Bleeding
- What is being tested?
- Olympus Quick Clip Pro - Single Use Repositionable Clips
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 2 sitesNetherlands
- Study dates
- 5 Mar 2018to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- laterally spreading or sessile polyp morphology (Paris classification 0-IIa/b/c) proximal to the splenic flexure, measuring 2-6 cm
- All patients aged >18 years undergoing an EMR
- Written informed consent
Who cannot join
- Previous resection or attempted resection of a lesion less than 30 days ago or in the same session,
- Clip deployed prior to the completion of the EMR for a perforation or a major intra-procedural bleeding not treatable by coagulation,
- Endoscopic appearance of invasive malignancy (non-lifting Kato D, Kudo V pit pattern),
- Pregnancy,
- Active inflammatory colonic conditions (e.g. inflammatory bowel disease),
- Insufficiently corrected anticoagulants AND/OR a clotting disorder (platelet count <50x109/l, INR > 1,5),
Show all 10Show fewer
- American Society of Anesthesiology (ASA) Grade IV-V,
- Macroscopic non-radical resection,
- >1 lesion in 1 session,
- Involvement of valvula Bauhin or appendiceal orificium
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Ziekenhuis St Jansdal
Harderwijk, Gelderland, 3844DG
Radboudumc
Nijmegen, Gelderland, 6525GA
About this study
Official title: Clip Placement Following Colonic Endoscopic Mucosal Resection (EMR). The CLIPPER Study: A Nationwide Multi-center Randomized Clinical Trail
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.
Read the 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:
- 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:
- Mild DB: any post-EMR medical consultation, unplanned hospital admission, or prolongation of hospital stays for 3 days or fewer.
- 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.
- 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).
- Conditions
- Polyp, Colonic, Bleeding
- Being tested
- Olympus Quick Clip Pro - Single Use Repositionable Clips
- Medical subject headings
- Colonic Polyps, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olympus Quick Clip Pro - Single Use Repositionable ClipsDevice
Also called prophylactic clipping, hemoclip
A hemoclip will be placed after every 0,5-1,0 cm of the resected area to proximate wound edges.
| Study group | Role | What they receive |
|---|---|---|
| Clip group | Experimental | Olympus Quick Clip Pro - Single Use Repositionable Clips will be used for Prophylactic clipping after EMR Receives: Device: Olympus Quick Clip Pro - Single Use Repositionable Clips |
| Control group | No intervention | Standard treatment after EMR (as described in the detailed study description above) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delayed bleeding
Clinical relevant delayed bleeding defined according to the ASGE working party document for adverse events in coloscopy.
Measured: 30 days
Secondary outcomes (3)
Adenoma recurrence
Recurrence rate will be determined by endoscopy and biopsies.
Measured: 180 days
Cost-effectiveness
A cost effectiveness analysis will be done, based on length of hospital stay and professional medical attendance and aided by an estimation of the impact on quality of health by the questionnaires EQ-5D, iMCQ, iPCQ.
Measured: 180 days
EMR scar evaluation
EMR scars will be evaluated by endoscopic photography and biopsies.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2017
- Study start5 Mar 2018
- Primary completion19 Aug 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Polyp, ColonicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- UMC Utrecht, Maastricht University Medical Center, Erasmus Medical Center, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Maxima Medical Center, Jeroen Bosch Ziekenhuis, Bernhoven Hospital, Isala, Canisius-Wilhelmina Hospital, Maasstad Hospital, Noordwest Ziekenhuisgroep, Meander Medisch Centrum, Catharina Ziekenhuis Eindhoven, Elisabeth-TweeSteden Ziekenhuis, St Jansdal Hospital, Leiden University Medical Center, Dutch Digestive Diseases Foundation, Franciscus Gasthuis, Bravis Hospital
- Responsible party
- Sponsor
- Investigators
- Erwin JM Van Geenen, dr, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03309683
- Sponsor's protocol ID
- R0003871
- Acronym
- CLIPPER
- Status last verified
- Dec 2021
- First submitted
- 9 Oct 2017
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Open for sharing IPD after study completion and publication. Currently not yet applicable as the study is still recruiting.
Publications
Kemper G, Turan AS, Schreuder RM, Schrauwen RWM, Hadithi M, Didden P, Bastiaansen BAJ, van der Spek BW, Droste JSTS, Schwartz MP, Hazen WL, Straathof JWA, Boonstra JJ, Alkhalaf A, Voogd FJ, Allajar D, de Graaf W, Koehestanie P, Roomer R, de Ridder RJJ, Moons LMG, Siersema PD, van Geenen EJM; Dutch EMR Study Group. The effect of prophylactic clipping on delayed bleeding after proximal colonic endoscopic mucosal resection: a multicenter, randomized controlled trial (CLIPPER). Endoscopy. 2025 Nov;57(11):1243-1250. doi: 10.1055/a-2637-3180. Epub 2025 Jul 22.
PubMed 40695477Turan AS, Moons LMG, Schreuder RM, Schoon EJ, Terhaar Sive Droste JS, Schrauwen RWM, Straathof JW, Bastiaansen BAJ, Schwartz MP, Hazen WL, Alkhalaf A, Allajar D, Hadithi M, van der Spek BW, Heine DGDN, Tan ACITL, de Graaf W, Boonstra JJ, Voogd FJ, Roomer R, de Ridder RJJ, Kievit W, Siersema PD, Didden P, van Geenen EJM; Dutch EMR Study Group. Clip placement to prevent delayed bleeding after colonic endoscopic mucosal resection (CLIPPER): study protocol for a randomized controlled trial. Trials. 2021 Jan 18;22(1):63. doi: 10.1186/s13063-020-04996-7.
PubMed 33461579
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clip Placement Following Colonic Endoscopic Mucosal Resection (EMR). The CLIPPER Study: A Nationwide Multi-center Randomized Clinical Trail
- ClinicalTrials.gov ID
- NCT03309683
- Acronym / sponsor ID
- CLIPPER / R0003871
- Conditions
- Polyp, Colonic, Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- UMC Utrecht, Maastricht University Medical Center, Erasmus Medical Center, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Maxima Medical Center, Jeroen Bosch Ziekenhuis, Bernhoven Hospital, Isala, Canisius-Wilhelmina Hospital, Maasstad Hospital, Noordwest Ziekenhuisgroep, Meander Medisch Centrum, Catharina Ziekenhuis Eindhoven, Elisabeth-TweeSteden Ziekenhuis, St Jansdal Hospital, Leiden University Medical Center, Dutch Digestive Diseases Foundation, Franciscus Gasthuis, Bravis Hospital
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 19 Aug 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 13 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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:
- Mild DB: any post-EMR medical consultation, unplanned hospital admission, or prolongation of hospital stays for 3 days or fewer.
- 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.
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clip group | Experimental | Device: Olympus Quick Clip Pro - Single Use Repositionable ClipsOlympus Quick Clip Pro - Single Use Repositionable Clips will be used for Prophylactic clipping after EMR |
| Control group | No intervention | –Standard treatment after EMR (as described in the detailed study description above) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- laterally spreading or sessile polyp morphology (Paris classification 0-IIa/b/c) proximal to the splenic flexure, measuring 2-6 cm
- All patients aged >18 years undergoing an EMR
- Written informed consent
Key exclusion criteria (10 listed)
- Previous resection or attempted resection of a lesion less than 30 days ago or in the same session,
- Clip deployed prior to the completion of the EMR for a perforation or a major intra-procedural bleeding not treatable by coagulation,
- Endoscopic appearance of invasive malignancy (non-lifting Kato D, Kudo V pit pattern),
- Pregnancy,
- Active inflammatory colonic conditions (e.g. inflammatory bowel disease),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olympus Quick Clip Pro - Single Use Repositionable ClipsAlso: prophylactic clipping, hemoclipA hemoclip will be placed after every 0,5-1,0 cm of the resected area to proximate wound edges. | Device | Clip group |
Primary outcome
Delayed bleeding
Time frame: 30 days
Clinical relevant delayed bleeding defined according to the ASGE working party document for adverse events in coloscopy.
3 secondary outcomes
Adenoma recurrence
Time frame: 180 days
Cost-effectiveness
Time frame: 180 days
EMR scar evaluation
Time frame: 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Derived from this study: PubMed 40695477Kemper G, Turan AS, Schreuder RM, Schrauwen RWM, Hadithi M, Didden P, Bastiaansen BAJ, van der Spek BW, Droste JSTS, Schwartz MP, Hazen WL, Straathof JWA, Boonstra JJ, Alkhalaf A, Voogd FJ, Allajar D, de Graaf W, Koehestanie P, Roomer R, de Ridder RJJ, Moons LMG, Siersema PD, van Geenen EJM; Dutch EMR Study Group. The effect of prophylactic clipping on delayed bleeding after proximal colonic endoscopic mucosal resection: a multicenter, randomized controlled trial (CLIPPER). Endoscopy. 2025 Nov;57(11):1243-1250. doi: 10.1055/a-2637-3180. Epub 2025 Jul 22.
- Derived from this study: PubMed 33461579Turan AS, Moons LMG, Schreuder RM, Schoon EJ, Terhaar Sive Droste JS, Schrauwen RWM, Straathof JW, Bastiaansen BAJ, Schwartz MP, Hazen WL, Alkhalaf A, Allajar D, Hadithi M, van der Spek BW, Heine DGDN, Tan ACITL, de Graaf W, Boonstra JJ, Voogd FJ, Roomer R, de Ridder RJJ, Kievit W, Siersema PD, Didden P, van Geenen EJM; Dutch EMR Study Group. Clip placement to prevent delayed bleeding after colonic endoscopic mucosal resection (CLIPPER): study protocol for a randomized controlled trial. Trials. 2021 Jan 18;22(1):63. doi: 10.1186/s13063-020-04996-7.
- Individual participant dataSharing planned: No. Open for sharing IPD after study completion and publication. Currently not yet applicable as the study is still recruiting.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erwin JM Van Geenen, dr principal investigator
Radboud University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olympus Quick Clip Pro - Single Use Repositionable Clips in people with Polyp, Colonic and Bleeding, run by Radboud University Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delayed bleeding (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03309683, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023; AzTrials last refreshed its copy on 31 Oct 2026.