Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
Study NCT ID:
NCT04218669
Status:
NOT_YET_RECRUITING
Last Update Posted:
2020-01-06
First Post:
2019-12-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Approach of Biliary Drainage in Hepatolithiasis Patients With Sphincter of Oddi Laxity
Sponsor:
xpgeng
Organization:
Study Overview
Official Title:
A Clinical Randomized Trial Comparing T-tube Drainage Versus Choledochojejunostomy in Hepatolithiasis Patients With Sphincter of Oddi Laxity
Status:
NOT_YET_RECRUITING
Status Verified Date:
2020-01
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:
BD
Brief Summary:
Residual and recurrent stones remain one of the most important challenges of hepatolithiasis which is reported in 20% to 50% of patients treated with these therapies. Up to now the most two common surgical procedures performed were choledochojejunostomy and T tube drainage as biliary drainage in hepatolithiasis. The goal of the present study was to evaluate the therapeutic safety, and perioperative and long-term outcomes of choledochojejunostomy versus T tube drainage for hepatolithiasis with sphincter of Oddi laxity.
Detailed Description:
Background: SOL results in reflux of duodenal fluid and enteric bacteria infection, which lead to the formation of stones in the biliary tract. Roux-en-Y hepaticojejunostomy (HJ) shows considerable advantage for prevention of reflux of intestinal content into the bile duct. As a result, A randomized controlled trial (RCT) evaluate the therapeutic safety, and perioperative and long-term outcomes of HJ versus T tube drainage for hepatolithiasis with SOL.
Intervention: In total, 210 patients who met the following eligibly criteria were included and were randomized to choledochojejunostomy arm or T tube drainage in a 1:1 ratio.
Clinical data include: the incidence of biliary complications (stone recurrence; biliary stricture; cholangitis); sphincter of oddi function; biliary leakage; mortality; hepatic injury; quality of life.
Intervention: In total, 210 patients who met the following eligibly criteria were included and were randomized to choledochojejunostomy arm or T tube drainage in a 1:1 ratio.
Clinical data include: the incidence of biliary complications (stone recurrence; biliary stricture; cholangitis); sphincter of oddi function; biliary leakage; mortality; hepatic injury; quality of life.
Study Oversight
Has Oversight DMC:
True
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?: