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Blood Flow Monitoring to Prevent Post-Polypectomy Induced Ulcer Bleeding

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ClinicalTrials.gov Identifier: NCT02875353
Recruitment Status : Recruiting
First Posted : August 23, 2016
Last Update Posted : October 29, 2018
Sponsor:
Collaborators:
University of California, Los Angeles
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Delayed Post-Polypectomy Induced Ulcer Hemorrhage Device: Doppler Endoscopic Probe Not Applicable

Detailed Description:
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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Blood Flow Monitoring to Prevent Post-Polypectomy Induced Ulcer Bleeding.
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Standard endoscopy (not 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.
Device: Doppler Endoscopic Probe
A colon length catheter (probe).

Experimental: Doppler treatment (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.
Device: Doppler Endoscopic Probe
A colon length catheter (probe).




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. The proportion of participants hospitalized. [ Time Frame: Outcome measure will be assessed at 30 days after participants are enrolled. ]
    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.

  2. The total number of hospitalized days. [ Time Frame: Outcome measure will be assessed at 30 days after participants are enrolled. ]
    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.



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ambulatory patients, 45 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02875353


Contacts
Contact: Dennis M Jensen, MD (310) 268-3569 dennis.jensen@va.gov

Locations
United States, California
University of California, Los Angeles, Ronald Reagan Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Dennis M Jensen, MD    310-268-3569    dennis.jensen@va.gov   
University of California, Los Angeles Santa Monica Recruiting
Santa Monica, California, United States, 90404
Contact: Alireza Sedarat, MD    201-655-8121    asedarat@mednet.ucla.edu   
VA Greater Los Angeles Healthcare System, West Los Angeles, CA Recruiting
West Los Angeles, California, United States, 90073
Contact: Dennis M Jensen, MD    310-268-3569    dennis.jensen@va.gov   
Principal Investigator: Dennis M. Jensen, MD         
Sponsors and Collaborators
VA Office of Research and Development
University of California, Los Angeles
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Dennis M. Jensen, MD VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02875353     History of Changes
Other Study ID Numbers: CLNB-01-15F
P30DK041301 ( U.S. NIH Grant/Contract )
CX-001403-01 ( Other Grant/Funding Number: Veterans Affairs Clinical Merit Review Grant )
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by VA Office of Research and Development:
Post-Polypectomy
Colon bleeding
Stigmata of recent hemorrhage

Additional relevant MeSH terms:
Ulcer
Hemorrhage
Pathologic Processes