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

Sponsor

Chang Gung Memorial Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03754491

Collaborator

(none)

196

Enrollment

Location

Arms

Actual Duration (Months)

10.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cholangitis; Choledocholithiasis	Behavioral: One stage treatment for mild and moderate cholangitis with choledocholithiasis	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

196 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

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.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)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2018

Actual Primary Completion Date :

Feb 14, 2020

Actual Study Completion Date :

Mar 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Behavioral: One stage treatment for mild and moderate cholangitis with choledocholithiasis one stage of stone removal in mild or moderate cholangitis.
Experimental: 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	Behavioral: One stage treatment for mild and moderate cholangitis with choledocholithiasis one stage of stone removal in mild or moderate cholangitis.

Arm

Intervention/Treatment

Experimental: 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

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

one stage of stone removal in mild or moderate cholangitis.

Experimental: 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

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

one stage of stone removal in mild or moderate cholangitis.

Outcome Measures

Primary Outcome Measures

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

Mortality [an average of 30 days]
Mortality during and after discharged

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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