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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2020-03-31

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.

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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.

Conditions

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Cholangitis; Choledocholithiasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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One stage stone removal in mild cholangitis

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

Group Type EXPERIMENTAL

One stage treatment for mild and moderate cholangitis with choledocholithiasis

Intervention Type BEHAVIORAL

one stage of stone removal in mild or moderate cholangitis.

One stage stone removal in moderate cholangitis

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

Group Type EXPERIMENTAL

One stage treatment for mild and moderate cholangitis with choledocholithiasis

Intervention Type BEHAVIORAL

one stage of stone removal in mild or moderate cholangitis.

Interventions

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One stage treatment for mild and moderate cholangitis with choledocholithiasis

one stage of stone removal in mild or moderate cholangitis.

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No