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OpenTrials
Completed

NCT Number: NCT03754491

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

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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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 813, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

One stage treatment for mild and moderate cholangitis with choledocholithiasis

Behavioral

one stage of stone removal in mild or moderate cholangitis.

Primary outcomes

  1. Post ERCP pancreatitis

    Time frame: After ERCP, an average of 7 days

    Serum amylase > 3 times of (115 IU/L) with clinical abdominal pain

  2. Bowel perforation

    Time frame: After ERCP, an average of 7 days

    Participants with sign of bowel perforation after ERCP

  3. Papillary bleeding

    Time frame: After ERCP, an average of 7 days

    Participants with papillary bleeding after ERCP

  4. Success rate of stone removal

    Time frame: an average of 14 days.

    Complete bile duct stone clearance

  5. Cost of hospitalization

    Time frame: From emergent department to the timing of being discharged, and an average of 30 days

    Total cost in two individual groups in hospitalization.

Secondary outcomes

  1. Mortality

    Time frame: an average of 30 days

    Mortality during and after discharged

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Acronym: ERCP

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 27, 2018
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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