Colonic Polypectomy in Cirrhotic Patients With Portal Hypertension

NCT06832826 | Active Not Recruiting

• 1 other identifier: ZU-IRB#851/1-Dec-2024
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis; Portal Hypertension Related to Cirrhosis; Polyp of Colon; Polypectomy

Keywords

colonic polyp; polypectomy; portal hypertension; post-polypectomy bleeding

Outcome Measures

Primary Outcomes (2)

• Immediate post polypectomy bleeding (IPPB)

  During procedure

• Delayed post polypectomy bleeding (DPPB)

  24 hours to 14 days

Secondary Outcomes (1)

• Type of polyps in patients with liver cirrhosis and portal hypertension

  14 days

Other Outcomes (1)

• Prediction of risk of post polypectomy bleeding

  6 months

Study Arms (1)

Liver cirrhosis patients with portal hypertension and colonic polyps

Colonic polypectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Liver cirrhosis patients with evidence of portal hypertension

You may qualify if:

• All liver cirrhosis patients with portal hypertension and colonic polyps

You may not qualify if:

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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Hospital

Zagazig, Sharqia Province, 44519, Egypt

Location

Related Publications (10)

• 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.

  PMID: 25048486 RESULT

• 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.

  PMID: 23512212 RESULT

• 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.

  PMID: 22648106 RESULT

• 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.

  PMID: 14722546 RESULT

• 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.

  PMID: 8674375 RESULT

• 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.

  PMID: 8253009 RESULT

• 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.

  PMID: 20601131 RESULT

• 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.

  PMID: 27677683 RESULT

• Tripodi A. Hemostasis abnormalities in cirrhosis. Curr Opin Hematol. 2015 Sep;22(5):406-12. doi: 10.1097/MOH.0000000000000164.

  PMID: 26203733 RESULT

• 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.

  PMID: 25536646 RESULT

MeSH Terms

Conditions

Liver Cirrhosis; Colonic Polyps; Hypertension, Portal

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical

Study Officials

• Ayman Sadek, MD

  Zagazig University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Study Record Dates

• First Submitted: January 12, 2025
• First Posted: February 18, 2025
• Study Start: January 14, 2024
• Primary Completion: June 26, 2024
• Study Completion: March 1, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02

Locations

EG (1)