Liver CirrhosisNCT06832826
Colonic Polypectomy in Cirrhotic Patients With Portal Hypertension
An observational study of Liver Cirrhosis and Portal Hypertension Related to Cirrhosis, run by Zagazig University at 1 site in Egypt.
Trial summary
The goal of this retrospective cohort study is to evaluate the risk of post-polypectomy bleeding following the colonoscopy resection of lower gastrointestinal polyps in patients with liver cirrhosis with portal hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis, Portal Hypertension Related to Cirrhosis, Polyp of Colon
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Jan 2024to 30 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Liver cirrhosis patients with evidence of portal hypertension
Who may be able to join
- All liver cirrhosis patients with portal hypertension and colonic polyps
Who cannot join
- Patients with platelet count less than 50,000/µL.
- Patients with hemoglobin levels less than 8 g/dL.
- Prothrombin Time more than 20 seconds.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Challenges in Colonic Polypectomy and Endoscopic Mucosal Resection in Cirrhotic Patients With Portal Hypertension: Single-Center Experience
The goal of this retrospective cohort study is to evaluate the risk of post-polypectomy bleeding following the colonoscopy resection of lower gastrointestinal polyps in patients with liver cirrhosis with portal hypertension. The main question it aims to answer is:
Does the risk of bleeding increase after colonoscopy polypectomy in patients with liver cirrhosis with portal hypertension?
Participants will be subjected to polypectomy of any colonic polyps.
- Keywords
- colonic polyp, polypectomy, portal hypertension, post-polypectomy bleeding
- Medical subject headings
- Liver Cirrhosis, Colonic Polyps, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Liver cirrhosis patients with portal hypertension and colonic polyps | Colonic polypectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate post polypectomy bleeding (IPPB)
Measured: During procedure
Delayed post polypectomy bleeding (DPPB)
Measured: 24 hours to 14 days
Secondary outcomes (1)
Type of polyps in patients with liver cirrhosis and portal hypertension
Using the Paris classification system for polyps
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start14 Jan 2024
- Primary completion26 Jun 2024
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies 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
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ayman Magd Eldin Mohammad Sadek, Zagazig University
- Investigators
- Ayman Sadek, MD, Study director, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832826
- Sponsor's protocol ID
- ZU-IRB#851/1-Dec-2024
- Status last verified
- Sep 2026
- First submitted
- 12 Jan 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee S, Park SJ, Cheon JH, Kim TI, Kim WH, Kang DR, Hong SP. Child-Pugh score is an independent risk factor for immediate bleeding after colonoscopic polypectomy in liver cirrhosis. Yonsei Med J. 2014 Sep;55(5):1281-8. doi: 10.3349/ymj.2014.55.5.1281.
PubMed 25048486Amarapurkar AD, Amarapurkar D, Choksi M, Bhatt N, Amarapurkar P. Portal hypertensive polyps: distinct entity. Indian J Gastroenterol. 2013 May;32(3):195-9. doi: 10.1007/s12664-013-0324-3. Epub 2013 Mar 20.
PubMed 23512212Jeon JW, Shin HP, Lee JI, Joo KR, Pack KM, Cha JM, Park JJ, Lim JU, Lim K. The risk of postpolypectomy bleeding during colonoscopy in patients with early liver cirrhosis. Surg Endosc. 2012 Nov;26(11):3258-63. doi: 10.1007/s00464-012-2334-0. Epub 2012 May 31.
PubMed 22648106Hui 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.
PubMed 14722546Gibbs DH, Opelka FG, Beck DE, Hicks TC, Timmcke AE, Gathright JB Jr. Postpolypectomy colonic hemorrhage. Dis Colon Rectum. 1996 Jul;39(7):806-10. doi: 10.1007/BF02054448.
PubMed 8674375Rosen L, Bub DS, Reed JF 3rd, Nastasee SA. Hemorrhage following colonoscopic polypectomy. Dis Colon Rectum. 1993 Dec;36(12):1126-31. doi: 10.1007/BF02052261.
PubMed 8253009Giannini EG, Greco A, Marenco S, Andorno E, Valente U, Savarino V. Incidence of bleeding following invasive procedures in patients with thrombocytopenia and advanced liver disease. Clin Gastroenterol Hepatol. 2010 Oct;8(10):899-902; quiz e109. doi: 10.1016/j.cgh.2010.06.018. Epub 2010 Jun 30.
PubMed 20601131Cocero N, Bezzi M, Martini S, Carossa S. Oral Surgical Treatment of Patients With Chronic Liver Disease: Assessments of Bleeding and Its Relationship With Thrombocytopenia and Blood Coagulation Parameters. J Oral Maxillofac Surg. 2017 Jan;75(1):28-34. doi: 10.1016/j.joms.2016.08.033. Epub 2016 Sep 2.
PubMed 27677683Tripodi A. Hemostasis abnormalities in cirrhosis. Curr Opin Hematol. 2015 Sep;22(5):406-12. doi: 10.1097/MOH.0000000000000164.
PubMed 26203733Mucino-Bermejo J, Carrillo-Esper R, Mendez-Sanchez N, Uribe M. Thrombosis and hemorrhage in the critically ill cirrhotic patients: five years retrospective prevalence study. Ann Hepatol. 2015 Jan-Feb;14(1):93-8.
PubMed 25536646
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Challenges in Colonic Polypectomy and Endoscopic Mucosal Resection in Cirrhotic Patients With Portal Hypertension: Single-Center Experience
- ClinicalTrials.gov ID
- NCT06832826
- Acronym / sponsor ID
- ZU-IRB#851/1-Dec-2024
- Keywords
- colonic polyp, polypectomy, portal hypertension, post-polypectomy bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 14 Jan 2024 (actual)
- Primary completion
- 26 Jun 2024 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 18 Feb 2025 (actual)
- 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 goal of this retrospective cohort study is to evaluate the risk of post-polypectomy bleeding following the colonoscopy resection of lower gastrointestinal polyps in patients with liver cirrhosis with portal hypertension. The main question it aims to answer is:
Does the risk of bleeding increase after colonoscopy polypectomy in patients with liver cirrhosis with portal hypertension?
Participants will be subjected to polypectomy of any colonic polyps.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver cirrhosis patients with portal hypertension and colonic polyps | – | –Colonic polypectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Liver cirrhosis patients with evidence of portal hypertension
Key inclusion criteria (1 listed)
- All liver cirrhosis patients with portal hypertension and colonic polyps
Key exclusion criteria (3 listed)
- Patients with platelet count less than 50,000/µL.
- Patients with hemoglobin levels less than 8 g/dL.
- Prothrombin Time more than 20 seconds.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Immediate post polypectomy bleeding (IPPB)
Time frame: During procedure
Delayed post polypectomy bleeding (DPPB)
Time frame: 24 hours to 14 days
1 secondary outcome
Type of polyps in patients with liver cirrhosis and portal hypertension
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Results publication: PubMed 25048486Lee S, Park SJ, Cheon JH, Kim TI, Kim WH, Kang DR, Hong SP. Child-Pugh score is an independent risk factor for immediate bleeding after colonoscopic polypectomy in liver cirrhosis. Yonsei Med J. 2014 Sep;55(5):1281-8. doi: 10.3349/ymj.2014.55.5.1281.
- Results publication: PubMed 23512212Amarapurkar AD, Amarapurkar D, Choksi M, Bhatt N, Amarapurkar P. Portal hypertensive polyps: distinct entity. Indian J Gastroenterol. 2013 May;32(3):195-9. doi: 10.1007/s12664-013-0324-3. Epub 2013 Mar 20.
- Results publication: PubMed 22648106Jeon JW, Shin HP, Lee JI, Joo KR, Pack KM, Cha JM, Park JJ, Lim JU, Lim K. The risk of postpolypectomy bleeding during colonoscopy in patients with early liver cirrhosis. Surg Endosc. 2012 Nov;26(11):3258-63. doi: 10.1007/s00464-012-2334-0. Epub 2012 May 31.
- Results publication: PubMed 14722546Hui 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 publication: PubMed 8674375Gibbs DH, Opelka FG, Beck DE, Hicks TC, Timmcke AE, Gathright JB Jr. Postpolypectomy colonic hemorrhage. Dis Colon Rectum. 1996 Jul;39(7):806-10. doi: 10.1007/BF02054448.
- Results publication: PubMed 8253009Rosen L, Bub DS, Reed JF 3rd, Nastasee SA. Hemorrhage following colonoscopic polypectomy. Dis Colon Rectum. 1993 Dec;36(12):1126-31. doi: 10.1007/BF02052261.
- Results publication: PubMed 20601131Giannini EG, Greco A, Marenco S, Andorno E, Valente U, Savarino V. Incidence of bleeding following invasive procedures in patients with thrombocytopenia and advanced liver disease. Clin Gastroenterol Hepatol. 2010 Oct;8(10):899-902; quiz e109. doi: 10.1016/j.cgh.2010.06.018. Epub 2010 Jun 30.
- Results publication: PubMed 27677683Cocero N, Bezzi M, Martini S, Carossa S. Oral Surgical Treatment of Patients With Chronic Liver Disease: Assessments of Bleeding and Its Relationship With Thrombocytopenia and Blood Coagulation Parameters. J Oral Maxillofac Surg. 2017 Jan;75(1):28-34. doi: 10.1016/j.joms.2016.08.033. Epub 2016 Sep 2.
- Results publication: PubMed 26203733Tripodi A. Hemostasis abnormalities in cirrhosis. Curr Opin Hematol. 2015 Sep;22(5):406-12. doi: 10.1097/MOH.0000000000000164.
- Results publication: PubMed 25536646Mucino-Bermejo J, Carrillo-Esper R, Mendez-Sanchez N, Uribe M. Thrombosis and hemorrhage in the critically ill cirrhotic patients: five years retrospective prevalence study. Ann Hepatol. 2015 Jan-Feb;14(1):93-8.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Ayman Sadek, MD study director
Zagazig University
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 Liver Cirrhosis and Portal Hypertension Related to Cirrhosis, run by Zagazig University at 1 site in Egypt.
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 3 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: finished, as of the sponsor's last update on 4 Sep 2026. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate post polypectomy bleeding (IPPB) (time frame: During procedure). The study lists 2 primary outcomes in all. 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 NCT06832826, which also lists 10 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 4 Sep 2026.