Doppler Probe Monitoring for Bleeding after Polyp Removal

Recruiting at 5 trial locations

Overseen By Dennis M Jensen, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must be taking: Anti-coagulants, Anti-platelets

Disqualifiers: Bleeding disorders, Abnormal coagulation, Colitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 day

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to prevent bleeding after colon polyp removal. It compares the use of a Doppler Endoscopic Probe (DEP), which checks and treats blood flow as needed, to standard procedures following medical guidelines. Candidates may be suitable if they take blood-thinning medications or have large polyps requiring removal. Participants should already plan to undergo a colonoscopy for screening, polyp detection, or abdominal pain evaluation. The trial aims to determine if the new method reduces bleeding risk more effectively than current practices. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance future medical procedures.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, it seems that participants are required to be on anti-coagulants or anti-platelet drugs, or have a specific condition related to polyp size, so you may need to continue your current medication if it falls into these categories.

What prior data suggests that the Doppler Endoscopic Probe is safe for monitoring bleeding after polyp removal?

Research has shown that using a Doppler endoscopic probe (DEP) is safe and straightforward. Studies have demonstrated that DEP can detect blood flow in the area where a polyp was removed, allowing doctors to assess bleeding risk. A recent study found that DEP use led to fewer bleeding problems compared to standard methods. Patients tolerated it well, with no major safety concerns reported.

In simpler terms, DEP appears to be a safe way to check blood flow after polyp removal. It helps doctors act quickly if needed, potentially reducing the risk of bleeding. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Doppler Endoscopic Probe technique because it offers a new way to monitor and potentially prevent bleeding after polyp removal, which is something standard endoscopy doesn't currently address directly. Unlike traditional approaches that rely on standard post-procedural guidelines for managing bleeding risks, the Doppler probe can detect arterial blood flow at the site of polyp removal. If blood flow is detected, immediate treatment options like hemoclipping or electrocoagulation can be applied to stop the bleeding. This proactive approach could lead to more effective management of post-polypectomy complications, potentially reducing the risk of bleeding and improving patient outcomes.

What evidence suggests that the Doppler Endoscopic Probe is effective for preventing delayed bleeding after polyp removal?

In this trial, participants will be assigned to different treatment arms to evaluate the effectiveness of using a Doppler Endoscopic Probe (DEP) for monitoring bleeding after polyp removal. Research has shown that a DEP can help identify and stop bleeding after colon polyp removal. In the Doppler treatment arm, checking blood flow with the DEP resulted in fewer cases of delayed bleeding compared to the standard endoscopy arm. The DEP detects blood flow in arteries, allowing doctors to stop it early and reduce the risk of bleeding. This method has proven safe and effective in managing bleeding without causing additional problems. Overall, DEP offers a promising way to improve outcomes for patients at high risk of bleeding after polyp removal. ^{2 3 5 6 7}

Who Is on the Research Team?

Dennis M Jensen, MD

Principal Investigator

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

Are You a Good Fit for This Trial?

This trial is for ambulatory patients aged 35 or older undergoing colonoscopy due to various reasons, including screening for cancer or polyps, abdominal pain, or bowel habit changes. Participants must be on anticoagulants like Warfarin or antiplatelet drugs such as aspirin and have a post-polypectomy induced ulcer (PPIU) of specific sizes. Those with bleeding disorders, inflammatory bowel diseases, unwillingness to consent or follow up are excluded.

Inclusion Criteria

I am 35 or older and can walk on my own, going for a planned health check.

I am being checked for stomach pain, changes in how often I go to the bathroom, or need a big polyp removed.

I am advised to take blood thinners or anti-platelet drugs due to my PPIU measurement.

Exclusion Criteria

I have ongoing rectal bleeding due to a long-term condition like hemorrhoids.

I have a bleeding disorder that causes me to bleed a lot after surgery or certain medical procedures.

I have a condition causing unexplained colon inflammation and frequent rectal bleeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo colonoscopy with either Doppler endoscopic probe (DEP) treatment or standard endoscopy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for bleeding, complications, or unscheduled visits for healthcare after polypectomies

4 weeks

3 visits (in-person) at 7, 14, and 30 days

What Are the Treatments Tested in This Trial?

Interventions

• Doppler Endoscopic Probe

Trial Overview

The study tests if using a Doppler Endoscopic Probe (DEP) to detect arterial blood flow and treat PPIUs can reduce delayed hemorrhage compared to standard medical guidelines alone. It's a randomized controlled trial focusing on high-risk patients who've had benign colon polyps removed and are at risk of post-procedure bleeding.

How Is the Trial Designed?

Group I: Standard endoscopy (not experimental) Experimental Treatment 1 Intervention

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.

Group II: Doppler treatment (experimental) Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Kaiser Permanente

Collaborator

Trials

563

Recruited

27,400,000+

Kaiser Permanente Bellflower Medical Offices

Collaborator

Trials

2

Recruited

420+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

UCLA Health - Santa Monica Medical Center

Collaborator

Trials

2

Recruited

380+

Published Research Related to This Trial

In a preliminary study of 12 patients, the use of Doppler probe ultrasonography (DOP) after endoscopic submucosal dissection (ESD) successfully detected 20 previously invisible vessels, leading to additional coagulation without any cases of post-ESD rebleeding.

The DOP method proved to be safe and feasible, with no adverse events reported, suggesting it could be an effective tool for reducing the risk of rebleeding in patients undergoing ESD for early gastric cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic Doppler probe ultrasonography for detecting blood flow at post-endoscopic submucosal dissection ulcers of the stomach. Shiratori, Y., Ikeya, T., Oguri, N., et al.[2020]

In a study of 62 patients with peptic ulcer bleeding, second-look endoscopy using Doppler endoscopic probes (DEPs) showed a low rebleeding rate of 3%, suggesting it is a safe option for high-risk patients.

While DEP evaluation during second-look endoscopy did not significantly improve outcomes compared to standard treatment, it may still be beneficial for selected patients at risk of rebleeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Doppler-Guided Second-Look Endoscopy in Peptic Ulcer Bleeding: A Randomised Controlled Trial. Nielsen, MM., Schaffalitzky de Muckadell, OB., Laursen, SB.[2023]

The Doppler probe method (DOP) used after gastric endoscopic submucosal dissection (ESD) showed a trend towards lower rates of delayed bleeding (2.0% vs. 8.6%) and readmissions due to bleeding compared to standard methods, suggesting it may enhance safety in post-ESD care.

No adverse events were reported with the DOP method, indicating it is a safe intervention; however, further prospective studies are needed to confirm its efficacy in reducing delayed bleeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Doppler probe method to reduce delayed bleeding after endoscopic submucosal dissection in the stomach: a propensity-score matched study (with video). Shiratori, Y., Ikeya, T., Yamamoto, K., et al.[2023]

The Doppler endoscopic probe (DEP) is effective for identifying high-risk lesions in nonvariceal upper gastrointestinal bleeding, as it shows a higher positive signal in lesions with recent hemorrhage stigmata, indicating a greater risk of rebleeding.

Using the DEP as a guide for endoscopic hemostasis improves the rates of successful treatment and better clinical outcomes compared to traditional visual methods, highlighting its potential for enhancing patient safety and efficacy in managing gastrointestinal bleeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Cutting Edge: Doppler Probe in Guiding Endoscopic Hemostasis. Ghassemi, KA., Jensen, DM.[2018]

In a study of 1002 patients undergoing colorectal polypectomy, instruction on checking for complete hemostasis significantly reduced the incidence of delayed post-polypectomy bleeding (DPPB) from 1.1% to 0.4%.

Despite the reduction in DPPB rates after instruction, factors such as the use of antithrombotic agents and hot polypectomy remained significant independent risk factors for delayed bleeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Instruction on Preventing Delayed Bleeding after Colorectal Polypectomy and Endoscopic Mucosal Resection. Okugawa, T., Oshima, T., Nakai, K., et al.[2021]

In a study of 69 patients with delayed postpolypectomy bleeding (DPPB) after removing small colorectal polyps, colonoscopy was found to be a safe and effective management method, achieving hemostasis in 89.9% of cases without any related adverse events.

The use of at least two hemoclips during the initial hemostatic colonoscopy was identified as a key factor for successful hemostasis, with all patients who received this treatment requiring no further interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic management of delayed bleeding after polypectomy of small colorectal polyps: two or more clips may be safe. Guo, XF., Yu, XA., Hu, JC., et al.[2022]

Bleeding from endoscopic biopsies is rare and usually resolves on its own, but certain patient groups, especially those on anticoagulants, are at higher risk and need careful evaluation before the procedure.

The article reviews various strategies for managing post-procedural bleeding, including techniques for local control and options for more severe cases that may require advanced interventions like interventional radiology or surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing complications in endoscopic procedures: bleeding from a biopsy site. Machado, NN., Jackson, T., Ladhani, HA., et al.[2017]

In a study of 16,925 patients who underwent colonoscopic polypectomy, delayed post-polypectomy bleeding (DPPB) occurred in only 0.74% of cases, highlighting its relative rarity as a complication.

Key independent risk factors for DPPB identified include younger age, male sex, hypertension, polyp size of 1 cm or larger, and polyp location in the proximal colon, leading to the development of a predictive nomogram with a C-index of 0.801, which can help identify high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishment of a model for predicting delayed post-polypectomy bleeding: A real-world retrospective study. Lu, Y., Zhou, X., Chen, H., et al.[2022]

The Doppler endoscopic probe (DEP) significantly reduces overall rebleeding rates in patients with nonvariceal upper gastrointestinal bleeding (NVUGIB), with an odds ratio of 0.27, indicating its effectiveness in managing this condition.

Using DEP to characterize bleeding lesions improves management outcomes, leading to lower rates of rebleeding and bleeding-related mortality, although the evidence remains of low certainty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of the endoscopic Doppler probe in nonvariceal upper gastrointestinal bleeding: Systematic review and meta-analysis. Chapelle, N., Martel, M., Bardou, M., et al.[2023]

The study found that the rate of delayed bleeding (DB) after cold snare polypectomy (CSP) for colorectal polyps was very low at 0.14%, based on an analysis of 18,007 patients.

Key risk factors for delayed bleeding included the use of antiplatelet and anticoagulant medications, larger polyp size (≥5 mm), and specific characteristics of the lesions, such as being located in the rectum or being polypoid.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk Factors of Delayed Bleeding After Cold Snare Polypectomy for Colorectal Polyps: A Multicenter Study. Inagaki, Y., Yoshida, N., Fukumoto, K., et al.[2022]

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