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

NCT03754491 | Completed DMC

• 1 other identifier: gimy54861439
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholangitis; Choledocholithiasis

Keywords

Acute cholangitis; choledocholithiasis; ERCP; One-stage treatment

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Mortality

  an average of 30 days

Study Arms (2)

One stage stone removal in mild cholangitis

EXPERIMENTAL

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 stone removal in moderate cholangitis

EXPERIMENTAL

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

Interventions

One stage treatment for mild and moderate cholangitis with choledocholithiasis BEHAVIORAL

one stage of stone removal in mild or moderate cholangitis.

One stage stone removal in mild cholangitis; One stage stone removal in moderate cholangitis

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• naïve papilla with a body temperature ≥37 °C who was diagnosed with mild to moderate cholangitis associated with choledocholithiasis.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 813, Taiwan

Location

Related Publications (3)

• 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.

  PMID: 23307003 RESULT

• 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.

  PMID: 26510180 RESULT

• Liang CM, Chiu YC, Lu LS, Wu CK, Sou FM, Chiu SM, Lee YC, Huang PY, Chuah SK, Kuo CM. Early and Direct Endoscopic Stone Removal in the Moderate Grade of Acute Cholangitis with Choledocholithiasis Was Safe and Effective: A Prospective Study. Life (Basel). 2022 Nov 30;12(12):2000. doi: 10.3390/life12122000.

  PMID: 36556365 DERIVED

MeSH Terms

Conditions

Cholangitis; Choledocholithiasis

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Common Bile Duct Diseases; Cholelithiasis

Study Officials

• CHIH-MING LIANG, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: November 27, 2018
• Study Start: October 1, 2018
• Primary Completion: February 14, 2020
• Study Completion: March 31, 2020
• Last Updated: April 8, 2021

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)