Blood Flow Monitoring to Prevent Post-Polypectomy Induced Ulcer Bleeding

NCT02875353 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: CLNB-01-15FCX-001403-01
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 3

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.

Conditions

Delayed Post-Polypectomy Induced Ulcer Hemorrhage

Keywords

Post-Polypectomy; Colon bleeding; Stigmata of recent hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The proportion of participants hospitalized.

  Outcome measure will be assessed at 30 days after participants are enrolled.

• The total number of hospitalized days.

  Outcome measure will be assessed at 30 days after participants are enrolled.

• The proportion of participants with rectal bleeding reported to us but not severe enough to be hospitalized

  Outcome measure will be assessed up to 30 days after enrollment

Study Arms (2)

Standard endoscopy (not experimental)

OTHER

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

Doppler treatment (experimental)

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

Interventions

Doppler Endoscopic Probe DEVICE

A colon length catheter (probe).

Doppler treatment (experimental); Standard endoscopy (not experimental)

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Kaiser Permanente: collaborator
• University of California, Los Angeles: collaborator

Study Sites (3)

Kaiser Permanente-Downey Medical Center

Downey, California, 90242, United States

Location

University of California, Los Angeles, Ronald Reagan Medical Center

Los Angeles, California, 90095, United States

Location

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073-1003, United States

Location

Related Publications (5)

• Hui AJ, Wong RM, Ching JY, Hung LC, Chung SC, Sung JJ. Risk of colonoscopic polypectomy bleeding with anticoagulants and antiplatelet agents: analysis of 1657 cases. Gastrointest Endosc. 2004 Jan;59(1):44-8. doi: 10.1016/s0016-5107(03)02307-1.

  PMID: 14722546 BACKGROUND

• 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.

  PMID: 23317580 BACKGROUND

• Zuckerman MJ, Hirota WK, Adler DG, Davila RE, Jacobson BC, Leighton JA, Qureshi WA, Rajan E, Hambrick RD, Fanelli RD, Baron TH, Faigel DO; Standards of Practice Committee of the American Society for Gastrointestinal Endoscopy. ASGE guideline: the management of low-molecular-weight heparin and nonaspirin antiplatelet agents for endoscopic procedures. Gastrointest Endosc. 2005 Feb;61(2):189-94. doi: 10.1016/s0016-5107(04)02392-2.

  PMID: 15729224 BACKGROUND

• 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.

  PMID: 23735447 BACKGROUND

• Wong RC. Endoscopic Doppler US probe for acute peptic ulcer hemorrhage. Gastrointest Endosc. 2004 Nov;60(5):804-12. doi: 10.1016/s0016-5107(04)02046-2. No abstract available.

  PMID: 15557966 BACKGROUND

Study Officials

• Dennis M. Jensen, MD

  VA Greater Los Angeles Healthcare System, West Los Angeles, CA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2016
• First Posted: August 23, 2016
• Study Start: February 15, 2017
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)