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

NCT06574542 | Completed DMC

• 1 other identifier: Si 484/2019
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Melena Due to Gastrointestinal Hemorrhage

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Diagnostic Yield of Colonoscopy

  30 day

Study Arms (1)

Patients with Melena, No Hematemesis, and Nondiagnostic EGD

EXPERIMENTAL

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); Diagnostic Test: Colonoscopy

Interventions

Push enteroscopy (PE) DIAGNOSTIC_TEST

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

Patients with Melena, No Hematemesis, and Nondiagnostic EGD

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.

Patients with Melena, No Hematemesis, and Nondiagnostic EGD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mahidol University: lead
• Siriraj Hospital: collaborator

Study Sites (1)

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

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Melena

Interventions

Double-Balloon Enteroscopy; Colonoscopy

Condition Hierarchy (Ancestors)

Gastrointestinal Hemorrhage; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Balloon Enteroscopy; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 25, 2024
• First Posted: August 28, 2024
• Study Start: July 8, 2019
• Primary Completion: October 30, 2022
• Study Completion: December 30, 2022
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Other researchers can contact us anytime.
• Access Criteria: We will provide our protocol and/or data upon request.

Locations

TH (1)