RECRUITING

Blood Flow Monitoring to Prevent Post-Polypectomy Induced Ulcer Bleeding

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Conditions

Delayed Post-Polypectomy Induced Ulcer HemorrhagePost-PolypectomyColon bleedingStigmata of recent hemorrhage

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Blood Flow Monitoring to Prevent Post-Polypectomy Induced Ulcer Bleeding

Quick Facts

Study Start:2017-02-15
Study Completion:2025-01-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02875353

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:35 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ambulatory patients, 35 years old or more and who are having:
  2. * elective, outpatient screening
  3. * surveillance colonoscopy for colon cancer or polyps
  4. * or being evaluated for abdominal pain or change in bowel habits ---or have a large polyp needing removal by EMR or ESD
  5. * Clinically the patient has to have a medical indication and recommendation by their primary care physician (PCP) or specialist to take:
  6. * daily anti-coagulants (Warfarin, low-molecular-weight heparin \[LMWH\] or a newer agent)
  7. * or an anti-platelet drug (aspirin as 81 mg or more, Clopidogrel, or newer agents) for PPIU's 10-14mm
  8. * or if not on one of these drugs, they must have a PPIU 15 mm
  9. * On colonoscopy, they are required to have:
  10. * benign appearing polyps and for 1 or more PPIU to be 10 mm in size (for the anti-coagulant or anti-platelet groups)
  11. * 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
  12. * In the case of bleeding from the PPIU during polypectomy, hemorrhage must be completely controlled
  1. * 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
  2. * Intrinsic bleeding disorder with a history of recurrent bleeding either after:
  3. * surgeries
  4. * angiography
  5. * or other invasive procedures
  6. * 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
  7. * Inflammatory bowel disease
  8. * Infectious colitis
  9. * Idiopathic colitis with a history of recurrent rectal bleeding
  10. * Recurrent rectal bleeding from another chronic colorectal condition such as:
  11. * colonic angiomas
  12. * radiation colitis
  13. * proctitis
  14. * or internal hemorrhoids
  15. * 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.
  16. * 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

Contacts and Locations

Study Contact

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

Principal Investigator

Dennis M. Jensen, MD
PRINCIPAL_INVESTIGATOR
VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Study Locations (Sites)

Kaiser Permanente-Downey Medical Center
Downey, California, 90242
United States
University of California, Los Angeles, Ronald Reagan Medical Center
Los Angeles, California, 90095
United States
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073-1003
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Dennis M. Jensen, MD, PRINCIPAL_INVESTIGATOR, VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-02-15
Study Completion Date2025-01-20

Study Record Updates

Study Start Date2017-02-15
Study Completion Date2025-01-20

Terms related to this study

Keywords Provided by Researchers

  • Post-Polypectomy
  • Colon bleeding
  • Stigmata of recent hemorrhage

Additional Relevant MeSH Terms

  • Delayed Post-Polypectomy Induced Ulcer Hemorrhage