Delayed Post-Polypectomy Induced Ulcer HemorrhageNCT02875353
Blood Flow Monitoring to Prevent Post-Polypectomy Induced Ulcer Bleeding
A study testing Doppler Endoscopic Probe in people with Delayed Post-Polypectomy Induced Ulcer Hemorrhage, run by VA Office of Research and Development at 3 sites in United States.
Trial summary
The primary specific aim is to perform a randomized controlled trial (RCT) to compare rates of delayed hemorrhage after DEP detection of arterial blood flow and focal treatment in PPIU's (treatment arm) with standard treatment using medical guidelines alone (controls) for prevention of delayed bleeding in high risk… Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Delayed Post-Polypectomy Induced Ulcer Hemorrhage
- What is being tested?
- Doppler Endoscopic Probe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Feb 2017to 31 Dec 2026
- Phase
- Interventional
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ambulatory patients, 35 years old or more and who are having:
- elective, outpatient screening
- surveillance colonoscopy for colon cancer or polyps
- or being evaluated for abdominal pain or change in bowel habits ---or have a large polyp needing removal by EMR or ESD
- Clinically the patient has to have a medical indication and recommendation by their primary care physician (PCP) or specialist to take:
- daily anti-coagulants (Warfarin, low-molecular-weight heparin [LMWH] or a newer agent)
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- or an anti-platelet drug (aspirin as 81 mg or more, Clopidogrel, or newer agents) for PPIU's 10-14mm
- or if not on one of these drugs, they must have a PPIU 15 mm
- On colonoscopy, they are required to have:
- benign appearing polyps and for 1 or more PPIU to be 10 mm in size (for the anti-coagulant or anti-platelet groups)
- or 15 mm or larger for the PPIU group who do not have to be (but may be) on these drugs that can induce bleeding
- In the case of bleeding from the PPIU during polypectomy, hemorrhage must be completely controlled
Who cannot join
- Inability or unwillingness to give written informed consent or to return to the investigators' medical centers for follow-up (FU) in the next 30 days, in case of delayed bleeding or other complications
- Intrinsic bleeding disorder with a history of recurrent bleeding either after:
- surgeries
- angiography
- or other invasive procedures
- Significantly abnormal coagulation tests related to co-morbid liver, hematologic, or infectious disorders and not anti-coagulant drugs, with platelet count < 100,000; international normalized ratio (INR) > 1.5; or partial thromboplastin time (PTT) more than 1.5 times normal
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- Inflammatory bowel disease
- Infectious colitis
- Idiopathic colitis with a history of recurrent rectal bleeding
- Recurrent rectal bleeding from another chronic colorectal condition such as:
- colonic angiomas
- radiation colitis
- proctitis
- or internal hemorrhoids
- A sessile polyp that can not be raised up by saline injection or Endoscopic mucosal resection (EMR) techniques nor completely removed by snare polypectomy either en block or in pieces and there is a suspicion about possible malignancy by the colonoscopist.
- Recently colonoscopy (within less than 3 years) unless the patient is referred for a large or multiple polyps (on more recent colonoscopy) and colonoscopic removal in the investigators' referral centers
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Kaiser Permanente-Downey Medical Center
Downey, California, 90242
University of California, Los Angeles, Ronald Reagan Medical Center
Los Angeles, California, 90095
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073-1003
About this study
The primary specific aim is to perform a randomized controlled trial (RCT) to compare rates of delayed hemorrhage after DEP detection of arterial blood flow and focal treatment in PPIU's (treatment arm) with standard treatment using medical guidelines alone (controls) for prevention of delayed bleeding in high risk patients (on anti-coagulants or anti-platelet drugs or with large ulcers) after snare resection of benign colon polyps.
Read the detailed description
VA Central Office recently opened back research study after suspension from March to Sept 2020 with COVID 19
Severe delayed post-polypectomy induced ulcer (PPIU) bleeding has become a much more common problem with the increased numbers of colonoscopies being performed and with more patients taking anti-coagulants or anti-platelet drugs. Current medical guidelines may reduce bleeding during polypectomy, but are not effective for prevention of delayed bleeding. Empiric closure of PPIU's with clips is not effective because ulcers > 15 mm cannot be closed, does not treat the underlying artery in the ulcer base, and when the clips often fall off within 7 the underlying artery is exposed. As preliminary results, the investigators studied delayed PPIU bleeds and their prevention, used a Doppler endoscopic probe (DEP) to localize arteries in PPIU's, reported the prevalence which rises significantly as ulcer size increases, and successfully obliterated blood flow with focal treatment. These studies form the basis for this new RCT. The primary specific aim is to perform a RCT to compare rates of delayed hemorrhage after DEP detection of arterial blood flow and focal treatment in PPIU's (treatment arm) with standard treatment using medical guidelines alone (controls) for prevention of delayed bleeding in high risk patients (on anti-coagulants or anti-platelet drugs or with large ulcers) after snare resection of benign colon polyps. Secondary specific aims are to evaluate the natural history and risk factors for delayed PPIU bleeding using univariate and multivariable analyses. This is a RCT performed by the CURE Hemostasis Research Group for high risk patients - those with PPIU's 15 mm in size or greater but not on drugs associated with bleeding; or patients who require anti-coagulants or anti-platelet drugs for treatment of co-morbid conditions and have PPIU's 10 mm or larger. Outpatients, scheduled for screening or surveillance colonoscopies, who give written informed consent and meet entry criteria will be randomized to control/no DEP (medical treatment without PPIU closure) or DEP (as a guide to arterial blood flow detection and focal obliteration of it with hemoclips and/or low power multipolar electrocautery [MPEC] probe). Patients will be prospectively followed at 7, 14, and 30 days for bleeding, complications, or unscheduled visits for healthcare after polypectomies.
- Being tested
- Doppler Endoscopic Probe
- Keywords
- Post-Polypectomy, Colon bleeding, Stigmata of recent hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler Endoscopic ProbeDevice
A colon length catheter (probe).
| Study group | Role | What they receive |
|---|---|---|
| Standard endoscopy (not experimental) | Other | For Standard treatment group, the Doppler probe will not be used, nor will hemoclip closure of post-polypectomy ulcers be attempted. Standard published guidelines will be followed for management of blood thinners (anti-coagulants) and/or aspirin like drugs (anti-platelet drugs) before and after the colonoscopic polypectomies. This is the standard of care at the investigators' medical centers and part of written instructions that are given to the participants and their referring physicians during the scheduling process and prior to their preparation for screening or surveillance outpatient colonoscopies. Receives: Device: Doppler Endoscopic Probe |
| Doppler treatment (experimental) | Experimental | A colon length catheter (probe) will be used to check the non-bleeding post-polypectomy ulcer with shallow and medium depth Doppler probe settings (< 4 mm deep) for arterial blood flow. If arterial flow is found, treatment through the colonoscope (either hemoclipping or multipolar electrocoagulation probe) will be used to stop the arterial flow. This will be confirmed by rechecking with Doppler probe after endoscopic treatment. Tatoos (Spot method) will be placed on two sides of the ulcer so treated. Receives: Device: Doppler Endoscopic Probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants with delayed Post-Polypectomy Induced Ulcer (PPIU) bleeds.
We will compare the proportion of participants with PPIU bleeding by 30 days follow up in Doppler endoscopic probe (DEP) versus standard treatment. The p value for testing this hypothesis will be computed using Fisher's exact test. The corresponding 95% confidence bounds for the true difference will also be reported.
Measured: Outcome measure will be assessed at 30 days after participants are enrolled.
Secondary outcomes (3)
The proportion of participants hospitalized.
We will compare the proportion of participants hospitalized for PPIU bleeds or other complications at 30 days, the number of participants in DEP group and standard group overall. Fisher's exact test will be used to compare the proportion hospitalized for PPIU bleeding by 30 days in DEP versus standard.
Measured: Outcome measure will be assessed at 30 days after participants are enrolled.
The total number of hospitalized days.
We will determine if number of hospitalized days follows a count distribution such as the Poisson or Negative Binomial distribution or if the log total hospital days follows a normal or other parametric distribution. We will therefore use the appropriate count model, t test or non parametric test (Wilcoxon rank sum) to compare the number of days hospitalized distribution in DEP versus standard as well as report the corresponding descriptive statistics (n, range, quartiles, median, mean, SD, frequencies) and histogram.
Measured: Outcome measure will be assessed at 30 days after participants are enrolled.
The proportion of participants with rectal bleeding reported to us but not severe enough to be hospitalized
Comparison of proportion of participants with rectal bleeding reported to us but not severe enough to be hospitalized. Fisher's exact test will be used to compare the proportion with this type of rectal bleeding after polypectomy up to 30 days after enrollment in the DEP versus standard treatment groups.
Measured: Outcome measure will be assessed up to 30 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study start15 Feb 2017
- Primary completion30 Jun 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Delayed Post-Polypectomy Induced Ulcer HemorrhageStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of California, Los Angeles, Kaiser Permanente
- Responsible party
- Sponsor
- Investigators
- Dennis M. Jensen, MD, Principal investigator, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875353
- Sponsor's protocol ID
- CLNB-01-15F
- Other IDs
- CX-001403-01
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2016
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hui AJ, Wong RM, Ching JY, Hung LC, Chung SC, Sung JJ. Risk of colonoscopic polypectomy bleeding with anticoagulants and antiplatelet agents: analysis of 1657 cases. Gastrointest Endosc. 2004 Jan;59(1):44-8. doi: 10.1016/s0016-5107(03)02307-1.
PubMed 14722546Liaquat H, Rohn E, Rex DK. Prophylactic clip closure reduced the risk of delayed postpolypectomy hemorrhage: experience in 277 clipped large sessile or flat colorectal lesions and 247 control lesions. Gastrointest Endosc. 2013 Mar;77(3):401-7. doi: 10.1016/j.gie.2012.10.024. Epub 2013 Jan 11.
PubMed 23317580Zuckerman MJ, Hirota WK, Adler DG, Davila RE, Jacobson BC, Leighton JA, Qureshi WA, Rajan E, Hambrick RD, Fanelli RD, Baron TH, Faigel DO; Standards of Practice Committee of the American Society for Gastrointestinal Endoscopy. ASGE guideline: the management of low-molecular-weight heparin and nonaspirin antiplatelet agents for endoscopic procedures. Gastrointest Endosc. 2005 Feb;61(2):189-94. doi: 10.1016/s0016-5107(04)02392-2.
PubMed 15729224Baron TH, Kamath PS, McBane RD. New anticoagulant and antiplatelet agents: a primer for the gastroenterologist. Clin Gastroenterol Hepatol. 2014 Feb;12(2):187-95. doi: 10.1016/j.cgh.2013.05.020. Epub 2013 Jun 2.
PubMed 23735447Wong RC. Endoscopic Doppler US probe for acute peptic ulcer hemorrhage. Gastrointest Endosc. 2004 Nov;60(5):804-12. doi: 10.1016/s0016-5107(04)02046-2. No abstract available.
PubMed 15557966
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow Monitoring to Prevent Post-Polypectomy Induced Ulcer Bleeding
- ClinicalTrials.gov ID
- NCT02875353
- Acronym / sponsor ID
- CLNB-01-15F
- Keywords
- Post-Polypectomy, Colon bleeding, Stigmata of recent hemorrhage
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of California, Los Angeles, Kaiser Permanente
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Aug 2016 (estimated)
- 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.
The primary specific aim is to perform a randomized controlled trial (RCT) to compare rates of delayed hemorrhage after DEP detection of arterial blood flow and focal treatment in PPIU's (treatment arm) with standard treatment using medical guidelines alone (controls) for prevention of delayed bleeding in high risk patients (on anti-coagulants or anti-platelet drugs or with large ulcers) after snare resection of benign colon polyps.
Detailed description
VA Central Office recently opened back research study after suspension from March to Sept 2020 with COVID 19
Severe delayed post-polypectomy induced ulcer (PPIU) bleeding has become a much more common problem with the increased numbers of colonoscopies being performed and with more patients taking anti-coagulants or anti-platelet drugs. Current medical guidelines may reduce bleeding during polypectomy, but are not effective for prevention of delayed bleeding. Empiric closure of PPIU's with clips is not effective because ulcers > 15 mm cannot be closed, does not treat the underlying artery in the ulcer base, and when the clips often fall off within 7 the underlying artery is exposed. As preliminary results, the investigators studied delayed PPIU bleeds and their prevention, used a Doppler endoscopic probe (DEP) to localize arteries in PPIU's, reported the prevalence which rises significantly as ulcer size increases, and successfully obliterated blood flow with focal treatment. These studies form the basis for this new RCT. The primary specific aim is to perform a RCT to compare rates of delayed hemorrhage after DEP detection of arterial blood flow and focal treatment in PPIU's (treatment arm) with standard treatment using medical guidelines alone (controls) for prevention of delayed bleeding in high risk patients (on anti-coagulants or anti-platelet drugs or with large ulcers) after snare resection of benign colon polyps. Secondary specific aims are to evaluate the natural history and risk factors for delayed PPIU bleeding using univariate and multivariable analyses. This is a RCT performed by the CURE Hemostasis Research Group for high risk patients - those with PPIU's 15 mm in size or greater but not on drugs associated with bleeding; or patients who require anti-coagulants or anti-platelet drugs for treatment of co-morbid conditions and have PPIU's 10 mm or larger. Outpatients, scheduled for screening or surveillance colonoscopies, who give written informed consent and meet entry criteria will be randomized to control/no DEP (medical treatment without PPIU closure) or DEP (as a guide to arterial blood flow detection and focal obliteration of it with hemoclips and/or low power multipolar electrocautery [MPEC] probe). Patients will be prospectively followed at 7, 14, and 30 days for bleeding, complications, or unscheduled visits for healthcare after polypectomies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard endoscopy (not experimental) | Other | Device: Doppler Endoscopic ProbeFor Standard treatment group, the Doppler probe will not be used, nor will hemoclip closure of post-polypectomy ulcers be attempted. Standard published guidelines will be followed for management of blood thinners (anti-coagulants) and/or aspirin like drugs (anti-platelet drugs) before and after the colonoscopic polypectomies. This is the standard of care at the investigators' medical centers and part of written instructions that are given to the participants and their referring physicians during the scheduling process and prior to their preparation for screening or surveillance outpatient colonoscopies. |
| Doppler treatment (experimental) | Experimental | Device: Doppler Endoscopic ProbeA colon length catheter (probe) will be used to check the non-bleeding post-polypectomy ulcer with shallow and medium depth Doppler probe settings (< 4 mm deep) for arterial blood flow. If arterial flow is found, treatment through the colonoscope (either hemoclipping or multipolar electrocoagulation probe) will be used to stop the arterial flow. This will be confirmed by rechecking with Doppler probe after endoscopic treatment. Tatoos (Spot method) will be placed on two sides of the ulcer so treated. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Ambulatory patients, 35 years old or more and who are having:
- Clinically the patient has to have a medical indication and recommendation by their primary care physician (PCP) or specialist to take:
- On colonoscopy, they are required to have:
- In the case of bleeding from the PPIU during polypectomy, hemorrhage must be completely controlled
Key exclusion criteria (16 listed)
- Inability or unwillingness to give written informed consent or to return to the investigators' medical centers for follow-up (FU) in the next 30 days, in case of delayed bleeding or other complications
- Intrinsic bleeding disorder with a history of recurrent bleeding either after:
- Significantly abnormal coagulation tests related to co-morbid liver, hematologic, or infectious disorders and not anti-coagulant drugs, with platelet count < 100,000; international normalized ratio (INR) > 1.5; or partial thromboplastin time (PTT) more than 1.5 times normal
- Inflammatory bowel disease
- Infectious colitis
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 |
|---|---|---|
| Doppler Endoscopic ProbeA colon length catheter (probe). | Device | Doppler treatment (experimental), Standard endoscopy (not experimental) |
Primary outcome
The proportion of participants with delayed Post-Polypectomy Induced Ulcer (PPIU) bleeds.
Time frame: Outcome measure will be assessed at 30 days after participants are enrolled.
We will compare the proportion of participants with PPIU bleeding by 30 days follow up in Doppler endoscopic probe (DEP) versus standard treatment. The p value for testing this hypothesis will be computed using Fisher's exact test. The corresponding 95% confidence bounds for the true difference will also be reported.
3 secondary outcomes
The proportion of participants hospitalized.
Time frame: Outcome measure will be assessed at 30 days after participants are enrolled.
The total number of hospitalized days.
Time frame: Outcome measure will be assessed at 30 days after participants are enrolled.
The proportion of participants with rectal bleeding reported to us but not severe enough to be hospitalized
Time frame: Outcome measure will be assessed up to 30 days after enrollment
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 17 Aug 2026.
- Background: PubMed 14722546Hui AJ, Wong RM, Ching JY, Hung LC, Chung SC, Sung JJ. Risk of colonoscopic polypectomy bleeding with anticoagulants and antiplatelet agents: analysis of 1657 cases. Gastrointest Endosc. 2004 Jan;59(1):44-8. doi: 10.1016/s0016-5107(03)02307-1.
- Background: PubMed 23317580Liaquat H, Rohn E, Rex DK. Prophylactic clip closure reduced the risk of delayed postpolypectomy hemorrhage: experience in 277 clipped large sessile or flat colorectal lesions and 247 control lesions. Gastrointest Endosc. 2013 Mar;77(3):401-7. doi: 10.1016/j.gie.2012.10.024. Epub 2013 Jan 11.
- Background: PubMed 15729224Zuckerman MJ, Hirota WK, Adler DG, Davila RE, Jacobson BC, Leighton JA, Qureshi WA, Rajan E, Hambrick RD, Fanelli RD, Baron TH, Faigel DO; Standards of Practice Committee of the American Society for Gastrointestinal Endoscopy. ASGE guideline: the management of low-molecular-weight heparin and nonaspirin antiplatelet agents for endoscopic procedures. Gastrointest Endosc. 2005 Feb;61(2):189-94. doi: 10.1016/s0016-5107(04)02392-2.
- Background: PubMed 23735447Baron TH, Kamath PS, McBane RD. New anticoagulant and antiplatelet agents: a primer for the gastroenterologist. Clin Gastroenterol Hepatol. 2014 Feb;12(2):187-95. doi: 10.1016/j.cgh.2013.05.020. Epub 2013 Jun 2.
- Background: PubMed 15557966Wong RC. Endoscopic Doppler US probe for acute peptic ulcer hemorrhage. Gastrointest Endosc. 2004 Nov;60(5):804-12. doi: 10.1016/s0016-5107(04)02046-2. No abstract available.
- Individual participant dataSharing planned: No
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.
Dennis M. Jensen, MD principal investigator
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doppler Endoscopic Probe in people with Delayed Post-Polypectomy Induced Ulcer Hemorrhage, run by VA Office of Research and Development at 3 sites in United States.
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 12 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
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?
The proportion of participants with delayed Post-Polypectomy Induced Ulcer (PPIU) bleeds. (time frame: Outcome measure will be assessed at 30 days after participants are enrolled.). 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 NCT02875353, which also lists 5 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 17 Aug 2026.