Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06574542
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-25
Brief Title:
The Role of Push Enteroscopy in Patients With Passing Melena With Nondiagnostic EGD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Diagnostic Yield of Push Enteroscopy in Patients With Passing Melena Without Hematemesis With Nondiagnostic EGD A Multicenter Study
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 476 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 476 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None