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The Role of Push Enteroscopy in Patients With Passing Melena With Nondiagnostic EGD.

NCT06574542 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2024-08-29

No results posted yet for this study

Summary

Melena is often caused by upper gastrointestinal (GI) bleeding; therefore, esophagogastroduodenoscopy (EGD) is the first preferred diagnostic tool. However, EGD fails to identify the bleeding source in about 25% of cases. Guidelines recommend colonoscopy for the subsequent investigation. However, the diagnostic yield of colonoscopy is reportedly low, varying from 4.76% to 35%. Even when EGD and colonoscopy have been performed, 4% to 15% of bleeding cases remain unexplained, suggesting small bowel origins. While video capsule endoscopy (VCE) is recommended due to its high diagnostic yield and noninvasive nature, its limitations include missing proximal small bowel lesions due to rapid transit and the inability to perform therapeutic interventions. Push enteroscopy (PE) is a straightforward, cost-effective technique with a reported 30% to 50% diagnostic success rate for such obscure GI bleeding. This study aims to evaluate the diagnostic yield of PE compared to colonoscopy in patients presenting with melena, no hematemesis, and negative EGD results.

Conditions

  • Melena Due to Gastrointestinal Hemorrhage

Interventions

DIAGNOSTIC_TEST

Push enteroscopy (PE)

All patients enrolled in this study underwent evaluation using push enteroscopy (PE)

DIAGNOSTIC_TEST

Colonoscopy

After push enteroscopy (PE), all patients subsequently underwent a colonoscopy on the same day or the next day. However, if a culprit lesion was identified during PE and the patient was considered at risk for undergoing colonoscopy, the colonoscopy was not performed and was presumed to be negative.

Sponsors & Collaborators

  • Siriraj Hospital

    collaborator OTHER

  • Mahidol University

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-08
Primary Completion
2022-10-30
Completion
2022-12-30

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06574542 on ClinicalTrials.gov