Polyp of ColonPiCAntNCT07007598
Prevention of Post-Polypectomy Colorectal Bleeding by Clips in Patients on Anticoagulants
An observational study of Polyp of Colon, run by Helios Kliniken Schwerin at 1 site in Germany.
Trial summary
This observational study aims to retrospectively determine if clips can prevent post-polypectomy bleeding in adults who have received restarted anticoagulants after a colorectal polypectomy, using a large, single-center patient registry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polyp of Colon
- What is being tested?
- Hemostatic clip
- Type of treatment
- Medical device
- How many people
- 10,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2025to 1 Nov 2026
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Adults who have received an endoscopic colorectal polypectomy
Who may be able to join
- adult who has received a colonoscopy with endoscopic colorectal polypectomy
- patient who has received at least one anticoagulant after polypectomy
Who cannot join
- Endoscopic polypectomy was combined with closure of the mucosal defect by a suturing device or full thickness resection device
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Helios Kliniken Schwerin
Schwerin, Mecklenburg-Vorpommern, 19055
Dr.med.Daniel Schmitz, Dr.med., +493855202601, Daniel.Schmitz@helios-gesundheit.de
Martin Kliment, +493855202601, Martin.Kliment@helios-gesundheit.de
About this study
Official title: Prevention of Post-Polypectomy Colorectal Bleeding by Clips in Patients on Anticoagulants: a Retrospective Single Center Propensity Score Analysis
This observational study aims to retrospectively determine if clips can prevent post-polypectomy bleeding in adults who have received restarted anticoagulants after a colorectal polypectomy, using a large, single-center patient registry.
The main question it aims to answer is:
Read more
Can clips prevent post-polypectomy bleeding in adults who have received restarted anticoagulants after a colorectal polypectomy? Researchers will compare adults who received preventive clipping after a polypectomy with those who did not, regarding colorectal bleeding after receiving restarted anticoagulants.
Participants have undergone a colorectal polypectomy and received restarted anticoagulants (acetylsalicylic acid excluded) after the procedure.
Read the detailed description
Screening colonoscopy allows early detection of cancer and removal of adenomas before they become malignant. Unresected polyps larger than 1 cm have a 24% risk of invasive adenocarcinoma. Post-polypectomy bleeding is influenced by factors such as polyp size, location, tumor type, anticoagulants and concomitant diseases. Prophylactic measures such as clipping show mixed results; selective clipping is cost-effective, but universal clipping is not. The updated ESGE guideline on colorectal polypectomy and endoscopic mucosal resection from 2024 recommends prophylactic endoscopic clip of the mucosal defect after endoscopic mucosal resection of large non-pedunculated polyps in the right colon to reduce the risk of delayed bleeding. However, there is no clear recommendation for patients on anticoagulants whether to use or not to use prophylactic clipping. Therefore, this observational study aims to retrospectively determine if clips can prevent post-polypectomy bleeding in adults who have received restarted anticoagulants after a colorectal polypectomy, using a large, single-center patient registry (> 10.000 colonoscopies).
- Conditions
- Polyp of Colon
- Being tested
- Hemostatic clip
- Keywords
- polyps, Hemorrhage, Anticoagulants
- Medical subject headings
- Colonic Polyps, Polyps, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemostatic clipDevice
The hemostatic clip is endoscopically applied after a colorectal polypectomy to close the mucosal defect.
| Study group | Role | What they receive |
|---|---|---|
| Colorectal polypectomy and prophylactic clipping before restarted anticoagulants | At least one prophylactic clip is applied to close the mucosal defect after polypectomy Receives: Device: Hemostatic clip | |
| Colorectal polypectomy without prophylactic clipping before restarted anticoagulant | A prophylactic clip is not applied to close the mucosal defect after polypectomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal Post-polypectomy bleeding
Mucosal defect-associated bleeding after removal of a colorectal polyp bei endoscopic polypectomy.
The metachronous interval bleeding rate is calculated by dividing the number of bleeding events by the number of colonoscopies with polypectomy. The following are counted as polypectomy bleeding:
- Polypectomy bleeding is visualized directly during a subsequent colonoscopy.
- Polypectomy bleeding is considered probable if a subsequent colonoscopy is performed due to lower gastrointestinal bleeding, and evidence of blood is found in association with the polypectomy.
- Polypectomy bleeding is considered probable if the patient was hospitalized for monitoring or had his hospital stay extended because he showed visible perianal bleeding. However, a colonoscopy was not performed because the bleeding had stopped spontaneously and/or the risk of a subsequent colonoscopy was deemed too high in relation to the potential benefits.
Measured: Up to 30 days after colorectal endoscopic polypectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start1 May 2025
- Primary completion1 May 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
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 of ColonStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Helios Kliniken Schwerin
- Sponsor type
- University, hospital or other
- Collaborators
- Medical School Hamburg
- Responsible party
- Principal investigator, Dr. med. Daniel Schmitz, Helios Kliniken Schwerin
- Investigators
- Daniel Schmitz, Dr.med., Principal investigator, Helios Kliniken Schwerin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007598
- Sponsor's protocol ID
- HeliosSchwerin GAS 01
- Acronym
- PiCAnt
- Status last verified
- Jun 2025
- First submitted
- 28 May 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nishad N, Thoufeeq MH. Post-polypectomy colorectal bleeding: current strategies and the way forward. Clin Endosc. 2025 Mar;58(2):191-200. doi: 10.5946/ce.2024.241. Epub 2024 Nov 27.
PubMed 39722137Ferlitsch M, Hassan C, Bisschops R, Bhandari P, Dinis-Ribeiro M, Risio M, Paspatis GA, Moss A, Libanio D, Lorenzo-Zuniga V, Voiosu AM, Rutter MD, Pellise M, Moons LMG, Probst A, Awadie H, Amato A, Takeuchi Y, Repici A, Rahmi G, Koecklin HU, Albeniz E, Rockenbauer LM, Waldmann E, Messmann H, Triantafyllou K, Jover R, Gralnek IM, Dekker E, Bourke MJ. Colorectal polypectomy and endoscopic mucosal resection: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2024. Endoscopy. 2024 Jul;56(7):516-545. doi: 10.1055/a-2304-3219. Epub 2024 Apr 26.
PubMed 38670139
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Post-Polypectomy Colorectal Bleeding by Clips in Patients on Anticoagulants: a Retrospective Single Center Propensity Score Analysis
- ClinicalTrials.gov ID
- NCT07007598
- Acronym / sponsor ID
- PiCAnt / HeliosSchwerin GAS 01
- Conditions
- Polyp of Colon
- Keywords
- polyps, Hemorrhage, Anticoagulants
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Helios Kliniken SchwerinUniversity, hospital or other
- Collaborators
- Medical School Hamburg
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 6 Jun 2025 (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.
This observational study aims to retrospectively determine if clips can prevent post-polypectomy bleeding in adults who have received restarted anticoagulants after a colorectal polypectomy, using a large, single-center patient registry.
The main question it aims to answer is:
Can clips prevent post-polypectomy bleeding in adults who have received restarted anticoagulants after a colorectal polypectomy? Researchers will compare adults who received preventive clipping after a polypectomy with those who did not, regarding colorectal bleeding after receiving restarted anticoagulants.
Participants have undergone a colorectal polypectomy and received restarted anticoagulants (acetylsalicylic acid excluded) after the procedure.
Detailed description
Screening colonoscopy allows early detection of cancer and removal of adenomas before they become malignant. Unresected polyps larger than 1 cm have a 24% risk of invasive adenocarcinoma. Post-polypectomy bleeding is influenced by factors such as polyp size, location, tumor type, anticoagulants and concomitant diseases. Prophylactic measures such as clipping show mixed results; selective clipping is cost-effective, but universal clipping is not. The updated ESGE guideline on colorectal polypectomy and endoscopic mucosal resection from 2024 recommends prophylactic endoscopic clip of the mucosal defect after endoscopic mucosal resection of large non-pedunculated polyps in the right colon to reduce the risk of delayed bleeding. However, there is no clear recommendation for patients on anticoagulants whether to use or not to use prophylactic clipping. Therefore, this observational study aims to retrospectively determine if clips can prevent post-polypectomy bleeding in adults who have received restarted anticoagulants after a colorectal polypectomy, using a large, single-center patient registry (> 10.000 colonoscopies).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colorectal polypectomy and prophylactic clipping before restarted anticoagulants | – | Device: Hemostatic clipAt least one prophylactic clip is applied to close the mucosal defect after polypectomy |
| Colorectal polypectomy without prophylactic clipping before restarted anticoagulant | – | –A prophylactic clip is not applied to close the mucosal defect after polypectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults who have received an endoscopic colorectal polypectomy
Key inclusion criteria (2 listed)
- adult who has received a colonoscopy with endoscopic colorectal polypectomy
- patient who has received at least one anticoagulant after polypectomy
Key exclusion criteria (1 listed)
- Endoscopic polypectomy was combined with closure of the mucosal defect by a suturing device or full thickness resection device
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 |
|---|---|---|
| Hemostatic clipThe hemostatic clip is endoscopically applied after a colorectal polypectomy to close the mucosal defect. | Device | Colorectal polypectomy and prophylactic clipping before restarted anticoagulants |
Primary outcome
Colorectal Post-polypectomy bleeding
Time frame: Up to 30 days after colorectal endoscopic polypectomy
Mucosal defect-associated bleeding after removal of a colorectal polyp bei endoscopic polypectomy. The metachronous interval bleeding rate is calculated by dividing the number of bleeding events by the number of colonoscopies with polypectomy. The following are counted as polypectomy bleeding: 1. Polypectomy bleeding is visualized directly during a subsequent colonoscopy. 2. Polypectomy bleeding is considered probable if a subsequent colonoscopy is performed due to lower gastrointestinal bleeding, and evidence of blood is found in association with the polypectomy. 3. Polypectomy bleeding is considered probable if the patient was hospitalized for monitoring or had his hospital stay extended because he showed visible perianal bleeding. However, a colonoscopy was not performed because the bleeding had stopped spontaneously and/or the risk of a subsequent colonoscopy was deemed too high in relation to the potential benefits.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Background: PubMed 39722137Nishad N, Thoufeeq MH. Post-polypectomy colorectal bleeding: current strategies and the way forward. Clin Endosc. 2025 Mar;58(2):191-200. doi: 10.5946/ce.2024.241. Epub 2024 Nov 27.
- Background: PubMed 38670139Ferlitsch M, Hassan C, Bisschops R, Bhandari P, Dinis-Ribeiro M, Risio M, Paspatis GA, Moss A, Libanio D, Lorenzo-Zuniga V, Voiosu AM, Rutter MD, Pellise M, Moons LMG, Probst A, Awadie H, Amato A, Takeuchi Y, Repici A, Rahmi G, Koecklin HU, Albeniz E, Rockenbauer LM, Waldmann E, Messmann H, Triantafyllou K, Jover R, Gralnek IM, Dekker E, Bourke MJ. Colorectal polypectomy and endoscopic mucosal resection: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2024. Endoscopy. 2024 Jul;56(7):516-545. doi: 10.1055/a-2304-3219. Epub 2024 Apr 26.
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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.
Daniel Schmitz, Dr.med. principal investigator
Helios Kliniken Schwerin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polyp of Colon, run by Helios Kliniken Schwerin at 1 site in Germany.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Schmitz, Dr. med. (+493855202601, Daniel.Schmitz@helios-gesundheit.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colorectal Post-polypectomy bleeding (time frame: Up to 30 days after colorectal endoscopic polypectomy). 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 NCT07007598, 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 18 Jun 2025.