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

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.

Study Overview

• Status: Completed
• Conditions: Melena Due to Gastrointestinal Hemorrhage
• Intervention / Treatment: Diagnostic test: Push enteroscopy (PE); Diagnostic test: Colonoscopy

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.

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University

Participation Criteria

Eligibility Criteria

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

Description

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.

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

Experimental: Patients with Melena, No Hematemesis, and Nondiagnostic EGD; Consecutive patients who presented with melena (defined as black, tarry stools) without hematemesis, in whom EGD did not identify a bleeding source, were included for further investigation

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Yield of Push Enteroscopy	This study aimed to evaluate the diagnostic yield of push enteroscopy in patients presenting with melena, without hematemesis, and with a negative EGD.	30 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Yield of Colonoscopy	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	30 day

Collaborators and Investigators

• Sponsor: Mahidol University
• Collaborators: Siriraj Hospital, Mahidol University, Bangkok, Thailand.

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2019
• Primary Completion (Actual): October 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: August 25, 2024
• First Submitted That Met QC Criteria: August 25, 2024
• First Posted (Actual): August 28, 2024

Study Record Updates

• Last Update Posted (Actual): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: colonoscopy; melena; small bowel bleeding; push enteroscopy; video capsule endoscopy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage; Melena
• Other Study ID Numbers: Si 484/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We are willing to provide our data to researchers who require it. For example, those who want to do systematic review and meta-analysis.
• IPD Sharing Time Frame: Other researchers can contact us anytime.
• IPD Sharing Access Criteria: We will provide our protocol and/or data upon request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No