Open
Actively Recruiting
Blood Flow Monitoring to Prevent Post-Polypectomy Induced Ulcer Bleeding
About
Brief 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 patients (on anti-coagulants or anti-platelet drugs or with large ulcers) after snare resection of benign colon polyps.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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:
- 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
- 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
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Study Stats
Protocol No.
15-002014
Category
GI Disorders
Principal Investigator
Contact
Location
- UCLA Westwood