Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06550973
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
PROceeding With Advanced Techniques in Case of Distal Malignant Biliary Obstruction and Difficult Biliary Cannulation comparEd With Therapeutic-EUS the PROMETHEUS Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Multicentric Trial PROceeding With Advanced Techniques in Case of Distal Malignant Biliary Obstruction and Difficult Biliary Cannulation comparEd With Therapeutic-EUS the PROMETHEUS Trial
Status:
NOT_YET_RECRUITING
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:
PROMETHEUS
Brief Summary:
Endoscopic retrograde cholangiopancreatography ERCP stands as the primary approach for addressing jaundice in individuals with distal malignant biliary obstruction A premise element in achieving success during therapeutic ERCP is selective biliary cannulation SBC Nevertheless SBC doesnt consistently yield favorable outcomes even among expert endoscopists failing in around 25 to 50 of cases with standard ERCP approach sphincterotome and guidewire
In such situations depending on the endoscopists experience and preference various advanced techniques come into play These encompass the double guidewire cannulation approach needle-knife precut papillotomy or fistulotomy and transpancreatic sphincterotomy serving as potential rescue methods
In recent times the EUS-guided approach has been gaining increasing significance Initially it was viewed as a rescue option in cases where advanced ERCP techniques failed 5-15 of cases More recently it has proved its feasibility as a first line alternative to ERCP in scenarios involving malignant biliary obstruction
In such situations depending on the endoscopists experience and preference various advanced techniques come into play These encompass the double guidewire cannulation approach needle-knife precut papillotomy or fistulotomy and transpancreatic sphincterotomy serving as potential rescue methods
In recent times the EUS-guided approach has been gaining increasing significance Initially it was viewed as a rescue option in cases where advanced ERCP techniques failed 5-15 of cases More recently it has proved its feasibility as a first line alternative to ERCP in scenarios involving malignant biliary obstruction
Detailed Description:
Rationale of the study Patients with distal malignant biliary obstruction have a higher risk of ERCP failure related to the difficulty of bile duct cannulation These patients after standard ERCP strategies failure undergo advanced ERCP rescue strategies and in case of failure to EUS guided biliary drainage HoweverEUS guided biliary drainage performed following the attempted advanced ERCP strategies it may carry the risk of adverse events of advance ERCP strategies We hypothesize that in this setting of patients early EUS guided biliary drainage in case of difficult biliary cannulation has a lower risk of post-procedural adverse events as well as better overall safety and efficacy profiles This could imply better outcomes such as for those patients who are planned to receive a chemotherapy before surgery in which a complication such as acute pancreatitis could delay the treatment
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