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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One stage treatment for mild and moderate cholangitis with choledocholithiasis | Behavioral | one stage of stone removal in mild or moderate cholangitis. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Mortality during and after discharged | an average of 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| CHIH-MING LIANG, MD | Chang Gung Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | 813 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23307003 | Result | 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. | |
| 26510180 |
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| ID | Term |
|---|---|
| D002761 | Cholangitis |
| D042883 | Choledocholithiasis |
| ID | Term |
|---|---|
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D003137 | Common Bile Duct Diseases |
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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.
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| 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. |
| 36556365 | Derived | 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. |
| D002769 | Cholelithiasis |