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Completed

NCT Number: NCT06574542

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

About this study

Melena is generally attributed to bleeding from the upper gastrointestinal (GI) tract, with esophagogastroduodenoscopy (EGD) serving as the primary diagnostic tool. However, EGD fails to detect bleeding sources in approximately 25% of cases, necessitating further investigation into potential mid-to-lower GI bleeding. Current guidelines recommend performing a colonoscopy in patients with melena and a negative EGD result before exploring small bowel sources. The effectiveness of colonoscopy in identifying bleeding sources varies significantly, with large-scale studies indicating a low detection rate of around 4.76%, while smaller studies report higher rates, ranging from 23% to 35%.

Despite thorough evaluations using both EGD and colonoscopy, the cause of overt GI bleeding remains unidentified in 4% to 15% of cases, prompting consideration of small bowel bleeding. Video capsule endoscopy (VCE) is often recommended in this situation due to its high diagnostic yield and noninvasive nature. However, VCE has limitations, such as missing proximal small bowel lesions and the inability to provide therapeutic interventions.

Push enteroscopy (PE) offers an alternative approach for investigating obscure GI bleeding. This straightforward endoscopic technique, which most gastroenterologists can perform without specialized equipment, is cost-effective and diagnostically efficient, with yields ranging from 30% to 50%. Utilizing PE in patients with melena and a negative EGD may help avoid unnecessary procedures like colonoscopy and VCE, ultimately reducing treatment costs.

This study aims to compare the diagnostic effectiveness of push enteroscopy (PE) and colonoscopy in patients presenting with melena, no hematemesis, and negative EGD results.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18 years or older.
  • Patients admitted to the hospital for acute gastrointestinal bleeding, presenting with symptoms of melena.
  • Patients who have undergone esophagogastroduodenoscopy (EGD) without identification of the source of gastrointestinal bleeding.
  • Patients who have signed informed consent to participate in the study.

Exclusion criteria

  • Patients with symptoms of hematemesis, coffee ground emesis, or detection of blood via a gastric lavage tube.
  • Patients with unstable vital signs before undergoing push enteroscopy.
  • Patients with conditions that contraindicate endoscopy, such as severe asthma or serious cardiac conditions.
  • Patients with a history of bleeding disorders or uncorrectable coagulation abnormalities.
  • Patients who have contraindications to bowel preparation with polyethylene glycol.
  • Pregnant patients.

Treatment and study plan

Push enteroscopy (PE)

Diagnostic Test

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

Colonoscopy

Diagnostic Test

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.

Primary outcomes

  1. Diagnostic Yield of Push Enteroscopy

    Time frame: 30 day

    This study aimed to evaluate the diagnostic yield of push enteroscopy in patients presenting with melena, without hematemesis, and with a negative EGD.

Secondary outcomes

  1. Diagnostic Yield of Colonoscopy

    Time frame: 30 day

    This study also aimed to evaluate the diagnostic yield of colonoscopy in the same patient population: those presenting with melena, without hematemesis, and with a negative EGD

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • Siriraj Hospital

Registry information

Official study title

The Diagnostic Yield of Push Enteroscopy in Patients With Passing Melena Without Hematemesis, With Nondiagnostic EGD : A Multicenter Study

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 28, 2024
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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