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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06574542
Enrollment
77
Registered
2024-08-28
Start date
2019-07-08
Completion date
2022-12-30
Last updated
2024-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melena Due to Gastrointestinal Hemorrhage

Keywords

small bowel bleeding, melena, push enteroscopy, colonoscopy, video capsule endoscopy

Brief 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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTPush enteroscopy (PE)

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

DIAGNOSTIC_TESTColonoscopy

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

Siriraj Hospital
CollaboratorOTHER
Mahidol University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patients aged 18 years or older. 2. Patients admitted to the hospital for acute gastrointestinal bleeding, presenting with symptoms of melena. 3. Patients who have undergone esophagogastroduodenoscopy (EGD) without identification of the source of gastrointestinal bleeding. 4. Patients who have signed informed consent to participate in the study.

Exclusion criteria

1. Patients with symptoms of hematemesis, coffee ground emesis, or detection of blood via a gastric lavage tube. 2. Patients with unstable vital signs before undergoing push enteroscopy. 3. Patients with conditions that contraindicate endoscopy, such as severe asthma or serious cardiac conditions. 4. Patients with a history of bleeding disorders or uncorrectable coagulation abnormalities. 5. Patients who have contraindications to bowel preparation with polyethylene glycol. 6. Pregnant patients.

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic Yield of Push Enteroscopy30 dayThis study aimed to evaluate the diagnostic yield of push enteroscopy in patients presenting with melena, without hematemesis, and with a negative EGD.

Secondary

MeasureTime frameDescription
Diagnostic Yield of Colonoscopy30 dayThis 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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026