Monitoring blood flow to prevent bleeding after polyp removal

Blood Flow Monitoring to Prevent Post-Polypectomy Induced Ulcer Bleeding

This study is testing whether a special tool can help prevent bleeding after polyp removal in high-risk patients, compared to standard treatment alone.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 35 Years and up
• Sex: All
• Sponsor: VA Office of Research and Development (fed)
• Drugs / interventions: radiation
• Locations: 3 sites (Downey, California and 2 other locations)
• Trial ID: NCT02875353 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the effectiveness of a Doppler endoscopic probe (DEP) in detecting arterial blood flow and providing focal treatment for delayed post-polypectomy induced ulcer (PPIU) bleeding against standard medical treatment alone. The study focuses on high-risk patients, particularly those on anticoagulants or with large ulcers, who are undergoing colonoscopy for polyp removal. By utilizing the DEP, the researchers hope to reduce the incidence of delayed hemorrhage following snare resection of benign colon polyps. The trial is a randomized controlled design, ensuring robust comparisons between the two treatment approaches.

Who should consider this trial

Good fit: Ideal candidates include patients aged 35 and older who are undergoing elective colonoscopy and have specific risk factors such as large polyps or are on anticoagulant or anti-platelet medications.

Not a fit: Patients who do not have polyps or are not at risk for delayed bleeding due to their medical history may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the rates of delayed bleeding in patients at high risk after polyp removal.

How similar studies have performed: Other studies have indicated that targeted interventions for delayed bleeding in similar patient populations may be effective, suggesting potential for success in this novel approach.

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

Where this trial is running

Downey, California and 2 other locations

• Kaiser Permanente-Downey Medical Center — Downey, California, United States (RECRUITING)
• University of California, Los Angeles, Ronald Reagan Medical Center — Los Angeles, California, United States (RECRUITING)
• VA Greater Los Angeles Healthcare System, West Los Angeles, CA — West Los Angeles, California, United States (RECRUITING)

Study contacts

• Principal investigator: Dennis M. Jensen, MD — VA Greater Los Angeles Healthcare System, West Los Angeles, CA
• Study coordinator: Dennis M Jensen, MD

Conditions: Delayed Post-Polypectomy Induced Ulcer Hemorrhage, Post-Polypectomy, Colon bleeding, Stigmata of recent hemorrhage