Delayed Post-Polypectomy Induced Ulcer Hemorrhage Clinical Trial
Official title:
Blood Flow Monitoring to Prevent Post-Polypectomy Induced Ulcer Bleeding.
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.
| Status | Recruiting |
| Enrollment | 235 |
| Est. completion date | June 30, 2024 |
| Est. primary completion date | June 30, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 35 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Kaiser Permanente-Downey Medical Center | Downey | California |
| United States | University of California, Los Angeles, Ronald Reagan Medical Center | Los Angeles | California |
| United States | VA Greater Los Angeles Healthcare System, West Los Angeles, CA | West Los Angeles | California |
| Lead Sponsor | Collaborator |
|---|---|
| VA Office of Research and Development | Kaiser Permanente Bellflower Medical Offices, University of California, Los Angeles |
United States,
Baron 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. — View Citation
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Liaquat 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. — View Citation
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Outcome measure will be assessed at 30 days after participants are enrolled. | |
| Secondary | 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. | Outcome measure will be assessed at 30 days after participants are enrolled. | |
| Secondary | 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. | Outcome measure will be assessed at 30 days after participants are enrolled. | |
| Secondary | 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. | Outcome measure will be assessed up to 30 days after enrollment |