Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06349954
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-04-01
Brief Title:
Effectiveness and Safety of Single-session Endoscopic Stone Extraction
Sponsor:
Beijing Friendship Hospital
Organization:
Beijing Friendship Hospital
Study Overview
Official Title:
Effectiveness and Safety of Single-session Endoscopic Stone Extraction for Acute Cholangitis Associated With Choledocholithiasis
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective study including approximately 64 patients with acute cholangitis accompanied with choledocholithiasis at Beijing Friendship Hospital All patients will be randomly allocate into single-session or two-session endoscopic stone extraction The investigators assessed the outcomes of single-session and two-session endoscopic stone extraction
Detailed Description:
Acute cholangitis is an acute inflammation caused by obstruction of the bile duct of which choledocholithiasis is the most common cause Without timely removal of the obstruction or control of the infection cholangitis can get worse and even become life-threatening Therefore timely and effective treatment is essential for patients with acute cholangitis combined with choledocholithiasis Endoscopic retrograde cholangiography ERCP is used as the first-line treatment for choledocholithiasis-associated acute cholangitis Previous guidelines recommended two-session endoscopic therapy Endoscopic biliary drainage as the initial treatment followed by endoscopic stone extraction after cholangitis improved In recent years studies have found that single-session endoscopic stone extraction is safe and effective for patients without serious organ function impairment Meanwhile single-session endoscopic lithotomy can avoid the second ERCP intervention which can relieve the pain of patients reduce medical costs and shorten the length of hospital stay However there is still insufficient evidence on the effectiveness and safety of early single-session ERCP lithotomy The aim of this study is to evaluate the efficacy and safety of single-session endoscopic stone extraction for acute cholangitis associated with choledocholithiasis so as to provide reference of clinical treatment
In a prospective study approximately 64 patients with acute cholangitis accompanied with choledocholithiasis will be involved The investigators assessed the outcomes of single-session and two-session endoscopic stone extraction
In a prospective study approximately 64 patients with acute cholangitis accompanied with choledocholithiasis will be involved The investigators assessed the outcomes of single-session and two-session endoscopic stone extraction
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None