Bleeding After GI EndoscopyEGDNCT02594813
Bleeding Rate After EGD and Colonoscopy in Patients Who Continue to Take Antithrombotic Agents
An observational study of Bleeding After GI Endoscopy, run by Showa Inan General Hospital at 1 site in Japan.
Trial summary
The bleeding rate of both EGD (including biopsy) and colonoscopy (including biopsy, cold or hot snare polypectomy, or EMR) in patients who continue to take various antithrombotic drugs is studied prospectively. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Bleeding After GI Endoscopy
- What is being tested?
- Biopsy, cold or hot snare polypectomy, or EMR
- Type of treatment
- Surgery or procedure
- How many people
- 10,000 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2015to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who continue to take antithrombotic drugs undergo EGD including biopsy and colonoscopy including biopsy, snare or hot polypectomy and/or EMR.
Who may be able to join
- Inclusion criteria is all patients who continue to take antithrombotic drugs and undergo EGD or colonoscopy
Who cannot join
- Patients who take prophylactic clipping after biopsy or polypectomy American Society of Anesthesiologists physical status of class IV or V
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
Showa Inan General Hospital
Komagane
Akira Horiuchi, MD, 81263288528 ext. 3012, horiuchi.akira@sihp.jp
About this study
The bleeding rate of both EGD (including biopsy) and colonoscopy (including biopsy, cold or hot snare polypectomy, or EMR) in patients who continue to take various antithrombotic drugs is studied prospectively. The immediate or delayed bleeding that requires hemostatic clipping or other endoscopic treatments is defined as the bleeding. Immediate bleeding requiring hemostatic clipping is defined as spurting or oozing which continued for more than 30 seconds. Delayed bleeding is defined as bleeding that requires the endoscopic treatment within 2 weeks after endoscopy. Prophylactic clipping is not performed after taking biopsy and doing polypectomy. Additionally, investigators evaluate the rate of injured submucosal arteries of the excised specimen when the bleeding occurs.
- Conditions
- Bleeding After GI Endoscopy
- Being tested
- Biopsy, cold or hot snare polypectomy, or EMR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy, cold or hot snare polypectomy, or EMRProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of delayed bleeding
Delayed bleeding defined as bleeding that required endoscopic treatment within 2 weeks after the procedure.
Measured: 10 years
Secondary outcomes (2)
the rate of immediate bleeding
Immediate bleeding defined as spurting or oozing which continued for more than 30 seconds.
Measured: 10 years
the number of clip used
The number of clip used during the procedures.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bleeding After GI EndoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Showa Inan General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akira Horiuchi, Showa Inan General Hospital
- Investigators
- Akira Horiuchi, MD, Principal investigator, Showa Inan General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594813
- Sponsor's protocol ID
- Bleeding rate
- Acronym
- EGD
- Status last verified
- May 2025
- First submitted
- 30 Oct 2015
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Nonaka E, Horiuchi I, Horiuchi A, Ukai S, Takahata N, Oishi K. The Risk of Colonoscopy-related Bleeding in Patients With or Without Continued Treatment With an Antithrombotic Agent. DEN Open. 2025 Jul 17;6(1):e70175. doi: 10.1002/deo2.70175. eCollection 2026 Apr.
PubMed 40677618Morita A, Horiuchi I, Tanaka N, Takada H, Graham DY, Horiuchi A. Managing bleeding risk after cold snare polypectomy in patients receiving direct-acting oral anticoagulants. Gastrointest Endosc. 2022 May;95(5):969-974. doi: 10.1016/j.gie.2022.01.005. Epub 2022 Jan 19.
PubMed 35065046
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bleeding Rate After EGD and Colonoscopy in Patients Who Continue to Take Antithrombotic Agents
- ClinicalTrials.gov ID
- NCT02594813
- Acronym / sponsor ID
- EGD / Bleeding rate
- Conditions
- Bleeding After GI Endoscopy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Showa Inan General HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The bleeding rate of both EGD (including biopsy) and colonoscopy (including biopsy, cold or hot snare polypectomy, or EMR) in patients who continue to take various antithrombotic drugs is studied prospectively. The immediate or delayed bleeding that requires hemostatic clipping or other endoscopic treatments is defined as the bleeding. Immediate bleeding requiring hemostatic clipping is defined as spurting or oozing which continued for more than 30 seconds. Delayed bleeding is defined as bleeding that requires the endoscopic treatment within 2 weeks after endoscopy. Prophylactic clipping is not performed after taking biopsy and doing polypectomy. Additionally, investigators evaluate the rate of injured submucosal arteries of the excised specimen when the bleeding occurs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who continue to take antithrombotic drugs undergo EGD including biopsy and colonoscopy including biopsy, snare or hot polypectomy and/or EMR.
Key inclusion criteria (1 listed)
- Inclusion criteria is all patients who continue to take antithrombotic drugs and undergo EGD or colonoscopy
Key exclusion criteria (1 listed)
- Patients who take prophylactic clipping after biopsy or polypectomy American Society of Anesthesiologists physical status of class IV or V
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biopsy, cold or hot snare polypectomy, or EMR | Procedure or surgery | – |
Primary outcome
the rate of delayed bleeding
Time frame: 10 years
Delayed bleeding defined as bleeding that required endoscopic treatment within 2 weeks after the procedure.
2 secondary outcomes
the rate of immediate bleeding
Time frame: 10 years
the number of clip used
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Derived from this study: PubMed 40677618Nonaka E, Horiuchi I, Horiuchi A, Ukai S, Takahata N, Oishi K. The Risk of Colonoscopy-related Bleeding in Patients With or Without Continued Treatment With an Antithrombotic Agent. DEN Open. 2025 Jul 17;6(1):e70175. doi: 10.1002/deo2.70175. eCollection 2026 Apr.
- Derived from this study: PubMed 35065046Morita A, Horiuchi I, Tanaka N, Takada H, Graham DY, Horiuchi A. Managing bleeding risk after cold snare polypectomy in patients receiving direct-acting oral anticoagulants. Gastrointest Endosc. 2022 May;95(5):969-974. doi: 10.1016/j.gie.2022.01.005. Epub 2022 Jan 19.
Related trials for Bleeding After GI Endoscopy
Not yet recruiting
Endoscopic Application of Hemostatic Drug Powder in Lower Gastrointestinal Bleeding: A Pilot Study
Bleeding After GI Endoscopy
Recruiting
Endoscopic Application of Tranexamic Acid and Sucralfate in Gastrointestinal Tumor Bleeding: A Randomized Controlled Trial
Bleeding After GI Endoscopy
RecruitingPhase 4
PPI Infusion Versus Oral Acid Pump Inhibitors for Bleeding Peptic Ulcers
Upper GI Bleeding, Proton Pump Inhibitors
Not yet recruitingPhase 4
Prevention of Delayed Post-polypectomy Bleeding by Endoscopic Sucralfate Spray in High-risk Patients: A Randomized Controlled Trial
Bleeding After GI Endoscopy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Akira Horiuchi, MD principal investigator
Showa Inan General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bleeding After GI Endoscopy, run by Showa Inan General Hospital at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Akira Horiuchi, MD (0265822121, horiuchi.akira@sihp.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of delayed bleeding (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02594813, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.