Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 813, Taiwan
NCT Number: NCT03754491
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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Notify Me18 year–90 year
All sexes
Interventional
Not applicable
Kaohsiung City, 813, Taiwan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
one stage of stone removal in mild or moderate cholangitis.
Time frame: After ERCP, an average of 7 days
Serum amylase > 3 times of (115 IU/L) with clinical abdominal pain
Time frame: After ERCP, an average of 7 days
Participants with sign of bowel perforation after ERCP
Time frame: After ERCP, an average of 7 days
Participants with papillary bleeding after ERCP
Time frame: an average of 14 days.
Complete bile duct stone clearance
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.
Time frame: an average of 30 days
Mortality during and after discharged
Chang Gung Memorial Hospital
Other
Division of Hepato-gastroenterology; Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung,Taiwan
Acronym: ERCP
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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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