Colonic Polypectomy in Cirrhotic Patients With Portal Hypertension

February 16, 2025 updated by: Ayman Magd Eldin Mohammad Sadek, Zagazig University

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Sharkia
      • Zagazig, Sharkia, Egypt, 44519
        • Zagazig university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Liver cirrhosis patients with evidence of portal hypertension

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Liver cirrhosis patients with portal hypertension and colonic polyps
Colonic polypectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Immediate post polypectomy bleeding (IPPB)
Time Frame: During procedure
During procedure
Delayed post polypectomy bleeding (DPPB)
Time Frame: 24 hours to 14 days
24 hours to 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type of polyps in patients with liver cirrhosis and portal hypertension
Time Frame: 14 days
Using the Paris classification system for polyps
14 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prediction of risk of post polypectomy bleeding
Time Frame: 6 months
Using the updated Endoscopic Resection Group of the Spanish Society of Endoscopy model and the Australian Colonic Endoscopic Resection model
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Investigators

  • Study Director: Ayman Sadek, MD, Zagazig University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2024

Primary Completion (Actual)

June 26, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

January 12, 2025

First Submitted That Met QC Criteria

February 16, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 16, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZU-IRB#851/1-Dec-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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