The Comparisons of One-stage Stone Removal in Mild and Moderate Cholangitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Division of Hepato-gastroenterology; Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung,Taiwan

Conditions
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Cholangitis; Choledocholithiasis

Intervention / Treatment
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* Behavioral: One stage treatment for mild and moderate cholangitis with choledocholithiasis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One stage stone removal in mild cholangitis<br>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 | Behavioral: One stage treatment for mild and moderate cholangitis with choledocholithiasis<br>* one stage of stone removal in mild or moderate cholangitis.<br>|
| Experimental: One stage stone removal in moderate cholangitis<br>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 | Behavioral: One stage treatment for mild and moderate cholangitis with choledocholithiasis<br>* one stage of stone removal in mild or moderate cholangitis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post ERCP pancreatitis | Serum amylase > 3 times of (115 IU/L) with clinical abdominal pain | After ERCP, an average of 7 days | 
| Bowel perforation | Participants with sign of bowel perforation after ERCP | After ERCP, an average of 7 days | 
| Papillary bleeding | Participants with papillary bleeding after ERCP | After ERCP, an average of 7 days | 
| Success rate of stone removal | Complete bile duct stone clearance | an average of 14 days. | 
| Cost of hospitalization | Total cost in two individual groups in hospitalization. | From emergent department to the timing of being discharged, and an average of 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Mortality during and after discharged | an average of 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute cholangitis, choledocholithiasis, ERCP, One-stage treatment