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

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

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.

Study Overview

• Status: Completed
• Conditions: Cholangitis; Choledocholithiasis
• Intervention / Treatment: Behavioral: One stage treatment for mild and moderate cholangitis with choledocholithiasis

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 Type: Interventional
• Enrollment (Actual): 196
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 813
    • Kaohsiung Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: CHIH-MING LIANG, MD, Chang Gung Memorial Hospital

Publications and helpful links

General Publications

• Miura F, Takada T, Strasberg SM, Solomkin JS, Pitt HA, Gouma DJ, Garden OJ, Buchler MW, Yoshida M, Mayumi T, Okamoto K, Gomi H, Kusachi S, Kiriyama S, Yokoe M, Kimura Y, Higuchi R, Yamashita Y, Windsor JA, Tsuyuguchi T, Gabata T, Itoi T, Hata J, Liau KH; Tokyo Guidelines Revision Comittee. TG13 flowchart for the management of acute cholangitis and cholecystitis. J Hepatobiliary Pancreat Sci. 2013 Jan;20(1):47-54. doi: 10.1007/s00534-012-0563-1.
• Eto K, Kawakami H, Haba S, Yamato H, Okuda T, Yane K, Hayashi T, Ehira N, Onodera M, Matsumoto R, Matsubara Y, Takagi T, Sakamoto N; Hokkaido Interventional EUS/ERCP study (HONEST) group. Single-stage endoscopic treatment for mild to moderate acute cholangitis associated with choledocholithiasis: a multicenter, non-randomized, open-label and exploratory clinical trial. J Hepatobiliary Pancreat Sci. 2015 Dec;22(12):825-30. doi: 10.1002/jhbp.296. Epub 2015 Nov 25.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): February 14, 2020
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: October 15, 2018
• First Submitted That Met QC Criteria: November 25, 2018
• First Posted (Actual): November 27, 2018

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: ERCP; Acute cholangitis; choledocholithiasis; One-stage treatment
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Common Bile Duct Diseases; Cholelithiasis; Cholangitis; Choledocholithiasis
• Other Study ID Numbers: gimy54861439

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No