Clinical trial NCT06832826: Colonic Polypectomy in Cirrhotic Patients With Portal Hypertension
Official title: Challenges in Colonic Polypectomy and Endoscopic Mucosal Resection in Cirrhotic Patients With Portal Hypertension: Single-Center Experience
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Liver Cirrhosis
Portal Hypertension Related to Cirrhosis
Polyp of Colon
Polypectomy
Keywords: colonic polyp
polypectomy
portal hypertension
post-polypectomy bleeding
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2025-02-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Liver cirrhosis patients with evidence of portal hypertension

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* All liver cirrhosis patients with portal hypertension and colonic polyps

Exclusion Criteria:

* Patients with platelet count less than 50,000/µL.
* Patients with hemoglobin levels less than 8 g/dL.
* Prothrombin Time more than 20 seconds.

Primary outcomes:
measure: Immediate post polypectomy bleeding (IPPB)
timeFrame: During procedure
measure: Delayed post polypectomy bleeding (DPPB)
timeFrame: 24 hours to 14 days
Secondary outcomes:
measure: Type of polyps in patients with liver cirrhosis and portal hypertension
timeFrame: 14 days
Other outcomes:
measure: Prediction of risk of post polypectomy bleeding
timeFrame: 6 months
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University Hospital
state: Sharkia
Study officials:
affiliation: Zagazig University
name: Ayman Sadek, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Amarapurkar 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.
citation: Jeon 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.
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.
citation: Gibbs 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.
citation: Rosen 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.
citation: Giannini 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.
citation: Cocero 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.
citation: Tripodi A. Hemostasis abnormalities in cirrhosis. Curr Opin Hematol. 2015 Sep;22(5):406-12. doi: 10.1097/MOH.0000000000000164.
citation: Mucino-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.