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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Sang Hyub Lee, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01425177
First received: August 26, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Effect of Saline Irrigation to Decrease Rate of Residual Common Bile Duct Stones

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
    • CT or USG
    • Symptomatic choledocholithiasis


Secondary Outcome Measures:
  • Recurrent CBD Stones [ Time Frame: Over 6months after procedure ] [ Designated as safety issue: No ]
    • CT, USG
    • Symptomatic choledocholithiasis

  • Cholangitis [ Time Frame: Over 6months after procedure ] [ Designated as safety issue: No ]
    - 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01425177

Contacts
Contact: Sang Eon Jang, M.D +82-10-7479-6271 medimax2@naver.com
Contact: Sang Hyup Lee, M.D. Ph.D +82-10-8708-6267 gidoctor@snubh.org

Locations
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    medimax2@naver.com   
Contact: Sang Hyub Lee, M.D. Ph.D    +82-10-8708-6267    gidoctor@snubh.org   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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:
Publications:

Responsible Party: Sang Hyub Lee, Assistant Professor of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01425177     History of Changes
Other Study ID Numbers: LSH 0909
Study First Received: August 26, 2011
Last Updated: August 26, 2011
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Gallstones
Cholelithiasis
Cholecystolithiasis
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 17, 2014