Blood Flow Monitoring to Prevent Post-Polypectomy Induced Ulcer Bleeding
Delayed Post-Polypectomy Induced Ulcer Hemorrhage
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About this trial
This is an interventional treatment trial for Delayed Post-Polypectomy Induced Ulcer Hemorrhage focused on measuring Post-Polypectomy, Colon bleeding, Stigmata of recent hemorrhage
Eligibility Criteria
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
Sites / Locations
- Kaiser Permanente-Downey Medical CenterRecruiting
- University of California, Los Angeles, Ronald Reagan Medical CenterRecruiting
- VA Greater Los Angeles Healthcare System, West Los Angeles, CARecruiting
Arms of the Study
Arm 1
Arm 2
Other
Experimental
Standard endoscopy (not experimental)
Doppler treatment (experimental)
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.
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.