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

Cholangitis; Choledocholithiasis Clinical Trial

— ERCP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03754491
• Other study ID #: gimy54861439
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: March 31, 2020

Study information

• Verified date: February 2020
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: March 31, 2020
• Est. primary completion date: February 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholangitis
• Cholangitis; Choledocholithiasis
• Choledocholithiasis

Intervention

Behavioral:
• One stage treatment for mild and moderate cholangitis with choledocholithiasis
one stage of stone removal in mild or moderate cholangitis.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

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 cholan — View Citation

Miura F, Takada T, Strasberg SM, Solomkin JS, Pitt HA, Gouma DJ, Garden OJ, Büchler 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; — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post ERCP pancreatitis	Serum amylase > 3 times of (115 IU/L) with clinical abdominal pain	After ERCP, an average of 7 days
Primary	Bowel perforation	Participants with sign of bowel perforation after ERCP	After ERCP, an average of 7 days
Primary	Papillary bleeding	Participants with papillary bleeding after ERCP	After ERCP, an average of 7 days
Primary	Success rate of stone removal	Complete bile duct stone clearance	an average of 14 days.
Primary	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	Mortality	Mortality during and after discharged	an average of 30 days