Cholangitis; Choledocholithiasis
Conditions
Keywords
Acute cholangitis, choledocholithiasis, ERCP, One-stage treatment
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.
Interventions
BEHAVIORALOne stage treatment for mild and moderate cholangitis with choledocholithiasis
one stage of stone removal in mild or moderate cholangitis.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Investigators will enroll 204 naïve papilla with a body temperature ≥37 °C who was diagnosed with mild or moderate cholangitis associated with choledocholithiasis for one-stage procedure to remove CBD stone.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* naïve papilla with a body temperature ≥37 °C who was diagnosed with mild to moderate cholangitis associated with choledocholithiasis.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Mortality | an average of 30 days | Mortality during and after discharged |
Countries
Taiwan
Outcome results
None listed