Prevalence Of Significant Endoscopic and Histopathologic Findings in Patients Presenting With Unexplained Iron Deficiency Anemia

Prevalence Of Significant Endoscopic and Histopathologic Findings in Patients Presenting With Unexplained Iron Deficiency Anemia: A Single Center Prospective Study

Background In practice, however, not all anaemic patients undergo appropriate diagnostic tests for the detection of iron deficiency anemia (IDA), and a significant portion of patients with IDA do not receive endoscopic evaluations. Accordingly, this study aimed to detect the prevalence of significant endoscopic (upper and lower endoscopy) and pathological findings in patients presenting with unexplained iron deficiency anaemia.

Methods One hundred twenty-four patients with confirmed IDA with no obvious cause who visited the Internal Medicine Clinic were randomly selected. Patients with active bleeding, pregnant or lactating females, or those with contraindications to sedation were excluded. Upper and lower endoscopy were held in the endoscopy unit of Specialized Medical Hospital and tissue biopsy from significant endoscopic findings was sent for histopathological examination.

Study Overview

• Status: Recruiting
• Conditions: Gastrointestinal Diseases
• Intervention / Treatment: Device: endoscopy

Detailed Description

Methods This is an open label prospective study conducted on one hundered twenty four patients with IDA who attended to the Endoscopy Unit, Specialized Medical hospital, Mansoura University. Patients with active bleeding, pregnant or lactating female, contraindication of sedation (uncontrolled diabetes mellitus, uncontrolled thyroid disorders, pregnancy, respiratory embarrassment) were excluded. The study protocol was approved by our ethical committee, and written consents were taken from all subjects before the procedure.

Measures All patients underwent Complete blood count (CBC) with detection of specific hematological parameters Serum ferritin, Iron and Total iron binding capacity, INR, serum albumin and bilirubin levels, ALT (Alanine Aminotransferase), AST (Aspartate aminotransferase), ESR, serum creatinine, occult blood in stool (FOBT kits ) small sample of stool collected in clean container, usually taken on consecutive days with precaution before testing include stopping non-steroidal anti-inflammatory drugs, vitamin C tablets ,raw vegetables and fruits and red meat often 48h to 72hour before test as they give false positive test (5) using immunochemical assay which detect globin chain of hemoglobin (6). All those proved with unexplained iron deficiency anemia were prepared to perform upper endoscopy and colonoscopy in later appointment.

Procedures Esophgogastroduodenoscopy and colonscopy were performed in our endoscopy unit by the same endoscopist under conscious sedation, Endoscopic examination was done by (PENTAX medical EPK-I 5000, Tokyo, Japan). We usually started with colonscopic examintion. Complete ileocolonscopy was done to all patients then esohgeogastroduoenoscopy , any macroscopic lesion was detedcted ,documented and tissue biopsy was taken and sent for histopathological examination by the same pathologist.

• Study Type: Interventional
• Enrollment (Estimated): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Asmaa Gameel, MD; Phone Number: 02 01025835429; Email: asmaagameel165@gmail.com

Study Locations

• Egypt
  • Dakhlia
    • Mansoura, Dakhlia, Egypt, 35516
      • Recruiting
      • Mansoura University
      • Contact: Asmaa Gameel, MD; Phone Number: 01025835429; Email: asmaagameel@mans.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• • Sex: both

  • Age: from 18 to 70 years
  • Cases confirmed iron deciency anemia with no obvious cause.
  • Significant UGI pathology includes Barrett's esophagus, esophagitis (LA class ≥ C), esophagogastric varices, peptic ulcer disease, duodenal ulcer, angioectasia , and cancer (Wuerth BA and Rockey DC,2018).
  • Significant LGI pathology includes adenomatous polyps >1cm, angioectasias, rectal ulcer, IBS , colon polyps and cancer. ( Ghassemi KA and Jensen DM,2013).

Exclusion Criteria:

• Patients with active bleeding, pregnant or lactating female, contraindication of sedation (uncontrolled diabetes mellitus, uncontrolled thyroid disorders, pregnancy, respiratory embarrassment) were excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: patients with iron deficiency anemia	Device: endoscopy; upper and lower endoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
diagnosis of the cause of anemia	two years

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: May 18, 2024
• First Submitted That Met QC Criteria: May 24, 2024
• First Posted (Actual): May 28, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2024
• Last Update Submitted That Met QC Criteria: May 24, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Gastrointestinal Diseases; Digestive System Diseases; Iron Deficiencies
• Other Study ID Numbers: MS.22.05.2001

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