Effect of Saline Irrigation to DEcrease Rate Of Residual Common Bile Duct Stones (SIDEROD)
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|ClinicalTrials.gov Identifier: NCT01425177|
Recruitment Status : Unknown
Verified August 2011 by Sang Hyub Lee, Seoul National University Hospital.
Recruitment status was: Recruiting
First Posted : August 29, 2011
Last Update Posted : August 29, 2011
In recent years, endoscopic sphincterotomy and stone extraction are standard procedures for the removal of bile duct stones.
After procedures, there are some complications such as stone recurrence, papillary stenosis, cholangitis and liver abscess. These recurrent symptomatic bile duct stones, despite increasing experience and success with the procedure, occur in 4% to 24% of patients.
Gallbladder stone, pneumobilia and many other various factors are known to be associated with CBD stone recurrence. Lithotripsy was also related to the development of recurrent stones. It is natural that small stone fragments left after lithotripsy may act as nidi for stone recurrence.
Small remaining stone could not be completely detected only using ERCP stone removal and remaining stone removal can reduce residual and recurrent stones. Saline irrigation was effective immediately after ERCP stone removal to remove remaining small stones.
Saline irrigation has many advantages such as easy to treatment during ERCP stone removal, almost no additional cost and rare side effect. This study The authors expect this study is a remarkable role of ERCP stone removal procedure.
|Condition or disease||Intervention/treatment||Phase|
|Common Bile Duct Gallstones||Procedure: Normal Saline Irrigation||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effect of Saline Irrigation to Decrease Rate of Residual Common Bile Duct Stones|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||December 2012|
|Experimental: Normal saline irrigation||
Procedure: Normal Saline Irrigation
After removing CBD stones with the ERCP, 200ml of the normal saline solution was irrigated into the common bile duct.
- Retained CBD stones [ Time Frame: From 3 to 6 months after procedure ]
- CT or USG
- Symptomatic choledocholithiasis
- Recurrent CBD Stones [ Time Frame: Over 6months after procedure ]
- CT, USG
- Symptomatic choledocholithiasis
- Cholangitis [ Time Frame: Over 6months after procedure ]- Fever, RUQ pain, Jaundice
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01425177
|Contact: Sang Eon Jang, M.Dfirstname.lastname@example.org|
|Contact: Sang Hyup Lee, M.D. Ph.Demail@example.com|
|Study Director:||Sang Hyub Lee, M.D. Ph.D||Department of Internal Medicine, Seoul National University Bundang Hospital|
|Principal Investigator:||Sang Eon Jang, M.D.||Department of Internal Medicine, Seoul National University Bundang Hospital|