The Comparisons of One-stage Stone Removal in Mild and Moderate Cholangitis
- Conditions
- Cholangitis; Choledocholithiasis
- Interventions
- Behavioral: One stage treatment for mild and moderate cholangitis with choledocholithiasis
- Registration Number
- NCT03754491
- Lead Sponsor
- Chang Gung Memorial Hospital
- Brief Summary
In expert comment, performing the sphincterotomy for choledocholithiasis with acute cholangitis may increase bleeding and pancreatitis risks (from 2% to 10%). Therefore, investigators often perform biliary drainage in acute stage, and arrange 2nd session ERCP for stone removal later. However, in the recent study, single-stage endoscopic treatment may be still effective (stone removal rate 90%) and safe for mild to moderate acute cholangitis associated with choledocholithiasis. Investigators will carry out a prospective trial to analyze one-stage retrograde endoscopic common bile duct stone removal in mild and moderate cholangitis with choledocholithiasis to determine the safety, successful rate, and complications in these two groups.
- Detailed Description
Investigators will enroll 204 naïve papilla with a body temperature ≥37 °C who was diagnosed with mild to moderate cholangitis associated with choledocholithiasis. The method of one-stage: performing the stone removal at the first session of ERCP. The pancreas duct stent will be placed for preventing post ERCP pancreatitis (PEP) if necessary. The indomethacin 100mg anal route will be administered for all patients without allergy history. All participants will receive the empiric antibiotics treatment for cholangitis.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 196
- naïve papilla with a body temperature ≥37 °C who was diagnosed with mild to moderate cholangitis associated with choledocholithiasis.
- procedural failure requiring an anatomy-modifying procedure, such as a Billroth II subtotal gastrectomy or R-en-Y gastrojejunostomy ;
- stenosis of the pyloric ring ;
- tumor-related obstruction;
- failure to locate the papilla ;
- active peptic ulcer bleeding ;
- intolerance due to inadequate sedation
- CBD sludge;
- non-naïve papilla in ERCP
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description One stage stone removal in mild cholangitis One stage treatment for mild and moderate cholangitis with choledocholithiasis one-stage stone removal at the first session of ERCP in mild cholangitis patients. The indomethacin 100mg anal route will be administered for all patients without allergy history One stage stone removal in moderate cholangitis One stage treatment for mild and moderate cholangitis with choledocholithiasis one-stage stone removal at the first session of ERCP in moderate cholangitis patients. The indomethacin 100mg anal route will be administered for all patients without allergy history
- Primary Outcome Measures
Name Time Method Post ERCP pancreatitis After ERCP, an average of 7 days Serum amylase \> 3 times of (115 IU/L) with clinical abdominal pain
Bowel perforation After ERCP, an average of 7 days Participants with sign of bowel perforation after ERCP
Papillary bleeding After ERCP, an average of 7 days Participants with papillary bleeding after ERCP
Success rate of stone removal an average of 14 days. Complete bile duct stone clearance
Cost of hospitalization From emergent department to the timing of being discharged, and an average of 30 days Total cost in two individual groups in hospitalization.
- Secondary Outcome Measures
Name Time Method Mortality an average of 30 days Mortality during and after discharged
Trial Locations
- Locations (1)
Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung, Taiwan