Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06613945
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
ERCP With and Without EUS Guided HGS for Bilateral Biliary Decompression in Malignant Hilar Biliary Obstruction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Endoscopic Retrograde Cholangiopancreatography With and Without Endoscopic Ultrasound Guided Hepaticogastrostomy for Bilateral Biliary Decompression in Malignant Hilar Biliary Obstruction
Status:
RECRUITING
Status Verified Date:
2024-09
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:
A prospective randomized clinical trial to evaluate efficacy and safety of combined EUS-HGS and ERCP compared to ERCP for bilateral biliary decompression in advanced malignant hilar biliary obstruction The primary outcome will be technical success clinical success procedural duration and re-interventions Secondary outcomes will be the rate of adverse events patients will be followed up at 1 and 3 month intervals
Detailed Description:
Bilateral stenting by Endoscopic Retrograde Cholangiopancreatography in malignant hilar biliary obstructions MHBO is challenging and technically difficult EUS hepaticogastrostomy EUS-HGS has been increasingly used as an alternative method to achieve internal biliary drainage in MHBO Because of the difficulty of ERCP in such scenario the combination of EUS-HGS and ERCP provides a possible chance of longer stent patency with less event of stent clogging Aim of the work to evaluate efficacy and safety of combined EUS-HGS and ERCP compared to ERCP for bilateral biliary decompression in advanced MHBO
The inclusion criteria will be presence of inoperable MHBO with elevated liver tests with serum bilirubin at least 3 times above the upper limit of normal The study patients will be randomized in 11 ratio to ERCP biliary drainage ERCP-BD group bilateral metallic stents insertion will be attempted by transpapilary approach Combined ERCP and EUS-HGS group unilateral metallic stent will be inserted on right side by transpapilary approach and a transmural stent will be inserted on left side by EUS
technical success clinical success procedural duration and re-interventions and adverse events will be assesed
The inclusion criteria will be presence of inoperable MHBO with elevated liver tests with serum bilirubin at least 3 times above the upper limit of normal The study patients will be randomized in 11 ratio to ERCP biliary drainage ERCP-BD group bilateral metallic stents insertion will be attempted by transpapilary approach Combined ERCP and EUS-HGS group unilateral metallic stent will be inserted on right side by transpapilary approach and a transmural stent will be inserted on left side by EUS
technical success clinical success procedural duration and re-interventions and adverse events will be assesed
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