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

Trial Summary

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 data supports the effectiveness of the treatment Doppler Endoscopic Probe (DEP) for monitoring bleeding after polyp removal?

Research shows that the Doppler Endoscopic Probe (DEP) is effective in guiding treatment for bleeding in the digestive system, like peptic ulcers and after certain stomach procedures, by detecting hidden blood vessels and helping prevent rebleeding. This suggests it could be useful for monitoring bleeding after polyp removal as well. ^{1 2 3 4 5}

How is the Doppler Endoscopic Probe treatment different from other treatments for bleeding after polyp removal?

The Doppler Endoscopic Probe (DEP) treatment is unique because it uses sound waves to detect blood flow, helping doctors identify and manage bleeding more precisely after polyp removal. This approach is different from traditional methods that rely on visual inspection or mechanical tools to control bleeding. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Research Team

Dennis M Jensen, MD

Principal Investigator

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Doppler-Guided Second-Look Endoscopy in Peptic Ulcer Bleeding: A Randomised Controlled Trial. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Endoscopic Doppler probe ultrasonography for detecting blood flow at post-endoscopic submucosal dissection ulcers of the stomach. [2020]

3. Australia pubmed.ncbi.nlm.nih.gov

Role of the endoscopic Doppler probe in nonvariceal upper gastrointestinal bleeding: Systematic review and meta-analysis. [2023]

4. Germany 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). [2023]

5. United States pubmed.ncbi.nlm.nih.gov

The Cutting Edge: Doppler Probe in Guiding Endoscopic Hemostasis. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Risk Factors of Delayed Bleeding After Cold Snare Polypectomy for Colorectal Polyps: A Multicenter Study. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Instruction on Preventing Delayed Bleeding after Colorectal Polypectomy and Endoscopic Mucosal Resection. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Endoscopic management of delayed bleeding after polypectomy of small colorectal polyps: two or more clips may be safe. [2022]

9. Italy pubmed.ncbi.nlm.nih.gov

Managing complications in endoscopic procedures: bleeding from a biopsy site. [2017]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Establishment of a model for predicting delayed post-polypectomy bleeding: A real-world retrospective study. [2022]