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Effect of Saline Irrigation to DEcrease Rate Of Residual Common Bile Duct Stones (SIDEROD)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by Seoul National University Hospital.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Sang Hyub Lee, Seoul National University Hospital Identifier:
First received: August 26, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted

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 Intervention Phase
Common Bile Duct Gallstones
Procedure: Normal Saline Irrigation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Prevention
Official Title: Effect of Saline Irrigation to Decrease Rate of Residual Common Bile Duct Stones

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Retained CBD stones [ Time Frame: From 3 to 6 months after procedure ]
    • CT or USG
    • Symptomatic choledocholithiasis

Secondary Outcome Measures:
  • Recurrent CBD Stones [ Time Frame: Over 6months after procedure ]
    • CT, USG
    • Symptomatic choledocholithiasis

  • Cholangitis [ Time Frame: Over 6months after procedure ]
    - Fever, RUQ pain, Jaundice

Estimated Enrollment: 160
Study Start Date: August 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • The patients were treated with CBD stone removal during therapeutic ERCP after finding CBD stones with CT, ultrasound or MRCP.
  • The patients were treated with CBD stone removal during diagnostic ERCP because of cholangitis or cholecystitis.

Exclusion Criteria:

  • Hemodynamic instability
  • Younger than 18
  • Mental illness
  • Received previous CBD stone removal
  • Hemolytic anemia, IHD stone, parasites in hepatobiliary system
  • Genetic, autoimmune, congenital biliary disorder
  • Liver or biliary surgery except cholecystectomy
  • Pancreatic cancer, cholangiocarcinoma, ampulla of vater cancer
  Contacts and Locations
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Please refer to this study by its identifier: NCT01425177

Contact: Sang Eon Jang, M.D +82-10-7479-6271
Contact: Sang Hyup Lee, M.D. Ph.D +82-10-8708-6267

Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seoungnam, Gyeonggi-do, Korea, Republic of, 463-707
Contact: Sang Eon Jang, M.D.    +82-10-7479-6271   
Contact: Sang Hyub Lee, M.D. Ph.D    +82-10-8708-6267   
Sponsors and Collaborators
Seoul National University Hospital
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
  More Information

Additional Information:

Responsible Party: Sang Hyub Lee, Assistant Professor of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University Hospital Identifier: NCT01425177     History of Changes
Other Study ID Numbers: LSH 0909
Study First Received: August 26, 2011
Last Updated: August 26, 2011

Keywords provided by Seoul National University Hospital:
Retained CBD Stones
Recurrent CBD Stones

Additional relevant MeSH terms:
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Pathological Conditions, Anatomical processed this record on April 24, 2017