Blood Flow Monitoring to Prevent Post-Polypectomy Induced Ulcer Bleeding

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  • sponsor
    VA Office of Research and Development
Updated on 30 May 2022


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.


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.

Condition Delayed Post-Polypectomy Induced Ulcer Hemorrhage
Treatment Doppler Endoscopic Probe
Clinical Study IdentifierNCT02875353
SponsorVA Office of Research and Development
Last Modified on30 May 2022


Yes No Not Sure

Inclusion Criteria

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)
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

Exclusion Criteria

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
or other invasive procedures
Inflammatory bowel disease
Infectious colitis
Significantly abnormal coagulation tests related to co-morbid liver, hematologic, or
infectious disorders and not anti-coagulant drugs, with platelet count <
Idiopathic colitis with a history of recurrent rectal bleeding
000; international normalized ratio (INR) > 1.5; or partial thromboplastin
Recurrent rectal bleeding from another chronic colorectal condition such as
colonic angiomas
time (PTT) more than 1.5 times normal
radiation colitis
or internal hemorrhoids
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
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
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