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

Chang Gung Medical Foundation

Status: Completed

Conditions: Cholangitis; Choledocholithiasis

Treatments: Behavioral: One stage treatment for mild and moderate cholangitis with choledocholithiasis

Study type: Interventional

Funder types: Other

Identifiers

NCT03754491

gimy54861439

Details and patient eligibility

About

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.

Full 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.

Enrollment: 196 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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196 participants in 2 patient groups

One stage stone removal in mild cholangitis

Experimental group

Description:

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

Treatment:

Behavioral: One stage treatment for mild and moderate cholangitis with choledocholithiasis

One stage stone removal in moderate cholangitis

Experimental group

Description:

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

Treatment:

Behavioral: One stage treatment for mild and moderate cholangitis with choledocholithiasis