Endoscopy in CKD With Iron Deficiency Anemia

Sponsor
Walid Ahmed Ragab Abdelhamid (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05240677
Collaborator
(none)
81
1
10.4
7.8

Study Details

Study Description

Brief Summary

Iron deficiency anemia is very common in CKD patients. Data about gastrointestinal lesions in Arab patients are insufficient.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Upper GIT endoscopy

Detailed Description

Anemia is a prevalent complication of renal diseases, and its magnitude intensifies as glomerular filtration rate deteriorates. Other factors causing anemia include iron, folate, or cobalamin deficit, hemolytic anemia, digestive system losses, bone marrow failure and erythropoietin resistance. Moreover, Uremia causes changes at several levels of the digestive system and there is a higher rate of gastrointestinal disorders in patients with chronic kidney disease (CKD).

Endoscopic disorders are predicted to be present in 40-90% of CKD patients. Asymptomatic individuals represent a diagnostic issue since they may be detected only during routine tests performed, or they may manifest with unusual non gastrointestinal complaints. Furthermore, asymptomatic malignancy of gastrointestinal system could exhibit a deceive clinical picture in the form of unexplained iron deficiency anemia, and discrimination of these pathologies is essential to minimize the eventual poor outcomes of these disorders in CKD patients.Data about gastrointestinal lesions in Arab patients are insufficient.

Thus aims of this study 1. To assess presence of potential GI disorders in CKD patients with iron deficiency anemia who don't have gastrointestinal symptoms.

  1. To assess the risk factors contributing to the various endoscopic findings.

Study Design

Study Type:
Observational
Anticipated Enrollment :
81 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Value of Esophageogastroduodenscopy in Assessment of Chronic Kidney Disease Patients With Iron Deficiency Anemia Without Gastrointestinal Symptoms
Actual Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
Mar 15, 2022
Anticipated Study Completion Date :
Mar 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Group 1

Chronic kidney diseases patients with iron deficiency anemia and eGFR ≥ 60 ml/min/1.73 m2

Procedure: Upper GIT endoscopy
Upper gastrointestinal endoscpy for all participants and gastric biopsy for histopathological examination for suspicious lesions

Group 2

Chronic kidney diseases patients with iron deficiency anemia and eGFR < 60 ml/min/1.73 m2.

Procedure: Upper GIT endoscopy
Upper gastrointestinal endoscpy for all participants and gastric biopsy for histopathological examination for suspicious lesions

Outcome Measures

Primary Outcome Measures

  1. Rate of upper gastrointestinal endoscopic findings In chronic kidney disease patients with iron deficiency anemia [6 months]

    Detect rate of upper GIT lesions in asymptomatic CKD patients with iron deficiency anemia using endoscopy followed by biopsy and histopathological examination

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients consent to enter the study.

  • CKD patients grade 1 to grade 5.

  • Iron deficiency anemia without gastrointestinal symptoms.

Exclusion Criteria:
  • Patients refusing to enter the study.

  • Patients having gastrointestinal symptoms.

  • Active infection, malignancy and hemolytic anemia.

  • Advanced liver disease or cirrhosis.

  • Folate or cobalamin deficiency.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zagazig university Zagazig Egypt

Sponsors and Collaborators

  • Walid Ahmed Ragab Abdelhamid

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Walid Ahmed Ragab Abdelhamid, Lecturer internal medicine, Zagazig University
ClinicalTrials.gov Identifier:
NCT05240677
Other Study ID Numbers:
  • 9145/2-2-2022
First Posted:
Feb 15, 2022
Last Update Posted:
Mar 3, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 3, 2022