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Blood Flow Monitoring to Prevent Post-Polypectomy Induced Ulcer Bleeding

Primary Purpose

Delayed Post-Polypectomy Induced Ulcer Hemorrhage

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Doppler Endoscopic Probe

About this trial

This is an interventional treatment trial for Delayed Post-Polypectomy Induced Ulcer Hemorrhage focused on measuring Post-Polypectomy, Colon bleeding, Stigmata of recent hemorrhage

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Kaiser Permanente-Downey Medical CenterRecruiting
University of California, Los Angeles, Ronald Reagan Medical CenterRecruiting
VA Greater Los Angeles Healthcare System, West Los Angeles, CARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Standard endoscopy (not experimental)

Doppler treatment (experimental)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The proportion of participants hospitalized.

We will compare the proportion of participants hospitalized for PPIU bleeds or other complications at 30 days, the number of participants in DEP group and standard group overall. Fisher's exact test will be used to compare the proportion hospitalized for PPIU bleeding by 30 days in DEP versus standard.

The total number of hospitalized days.

We will determine if number of hospitalized days follows a count distribution such as the Poisson or Negative Binomial distribution or if the log total hospital days follows a normal or other parametric distribution. We will therefore use the appropriate count model, t test or non parametric test (Wilcoxon rank sum) to compare the number of days hospitalized distribution in DEP versus standard as well as report the corresponding descriptive statistics (n, range, quartiles, median, mean, SD, frequencies) and histogram.

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

Comparison of proportion of participants with rectal bleeding reported to us but not severe enough to be hospitalized. Fisher's exact test will be used to compare the proportion with this type of rectal bleeding after polypectomy up to 30 days after enrollment in the DEP versus standard treatment groups.

Full Information

NCT ID

NCT02875353

First Posted

August 5, 2016

Last Updated

July 19, 2023

Sponsor

VA Office of Research and Development

Collaborators

University of California, Los Angeles, Kaiser Permanente Bellflower Medical Offices

1. Study Identification

Unique Protocol Identification Number

NCT02875353

Brief Title

Blood Flow Monitoring to Prevent Post-Polypectomy Induced Ulcer Bleeding

Official Title

Blood Flow Monitoring to Prevent Post-Polypectomy Induced Ulcer Bleeding.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 1, 2017 (Actual)

Primary Completion Date

October 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VA Office of Research and Development

Collaborators

University of California, Los Angeles, Kaiser Permanente Bellflower Medical Offices

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

VA Central Office recently opened back research study after suspension from March to Sept 2020 with COVID 19 Severe delayed post-polypectomy induced ulcer (PPIU) bleeding has become a much more common problem with the increased numbers of colonoscopies being performed and with more patients taking anti-coagulants or anti-platelet drugs. Current medical guidelines may reduce bleeding during polypectomy, but are not effective for prevention of delayed bleeding. Empiric closure of PPIU's with clips is not effective because ulcers > 15 mm cannot be closed, does not treat the underlying artery in the ulcer base, and when the clips often fall off within 7 the underlying artery is exposed. As preliminary results, the investigators studied delayed PPIU bleeds and their prevention, used a Doppler endoscopic probe (DEP) to localize arteries in PPIU's, reported the prevalence which rises significantly as ulcer size increases, and successfully obliterated blood flow with focal treatment. These studies form the basis for this new RCT. The primary specific aim is to perform a 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. Secondary specific aims are to evaluate the natural history and risk factors for delayed PPIU bleeding using univariate and multivariable analyses. This is a RCT performed by the CURE Hemostasis Research Group for high risk patients - those with PPIU's 15 mm in size or greater but not on drugs associated with bleeding; or patients who require anti-coagulants or anti-platelet drugs for treatment of co-morbid conditions and have PPIU's 10 mm or larger. Outpatients, scheduled for screening or surveillance colonoscopies, who give written informed consent and meet entry criteria will be randomized to control/no DEP (medical treatment without PPIU closure) or DEP (as a guide to arterial blood flow detection and focal obliteration of it with hemoclips and/or low power multipolar electrocautery [MPEC] probe). Patients will be prospectively followed at 7, 14, and 30 days for bleeding, complications, or unscheduled visits for healthcare after polypectomies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Delayed Post-Polypectomy Induced Ulcer Hemorrhage

Keywords

Post-Polypectomy, Colon bleeding, Stigmata of recent hemorrhage

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard endoscopy (not experimental)

Arm Type

Other

Arm Description

Arm Title

Doppler treatment (experimental)

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Doppler Endoscopic Probe

Intervention Description

A colon length catheter (probe).

Primary Outcome Measure Information:

Title

The proportion of participants with delayed Post-Polypectomy Induced Ulcer (PPIU) bleeds.

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

The proportion of participants hospitalized.

Description

Time Frame

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

Title

The total number of hospitalized days.

Description

Time Frame

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

Title

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

Description

Time Frame

Outcome measure will be assessed up to 30 days after enrollment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dennis M Jensen, MD

Phone

(310) 268-3569

dennis.jensen@va.gov

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dennis M. Jensen, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kaiser Permanente-Downey Medical Center

City

Downey

State/Province

California

ZIP/Postal Code

90242

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kevin T Kao

Phone

562-657-4441

kevin.T.Kao@kp.org

First Name & Middle Initial & Last Name & Degree

Gareth S Dulai

Phone

5626574242

Gareth.S.Dulai@kp.org

Facility Name

University of California, Los Angeles, Ronald Reagan Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dennis M Jensen, MD

Phone

310-268-3569

dennis.jensen@va.gov

Facility Name

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

City

West Los Angeles

State/Province

California

ZIP/Postal Code

90073-1003

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dennis M Jensen, MD

Phone

310-268-3569

dennis.jensen@va.gov

First Name & Middle Initial & Last Name & Degree

Dennis M. Jensen, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

14722546

Citation

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.

Results Reference

background

PubMed Identifier

23317580

Citation

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.

Results Reference

background

PubMed Identifier

15729224

Citation

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.

Results Reference

background

PubMed Identifier

23735447

Citation

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.

Results Reference

background

PubMed Identifier

15557966

Citation

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.

Results Reference

background

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Blood Flow Monitoring to Prevent Post-Polypectomy Induced Ulcer Bleeding

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