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

NCT01425177 | Unknown Phase 3 DMC

• 1 other identifier: LSH 0909
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Common Bile Duct Gallstones

Keywords

Retained CBD Stones; Recurrent CBD Stones

Outcome Measures

Primary Outcomes (1)

• Retained CBD stones

  * CT or USG * Symptomatic choledocholithiasis

  From 3 to 6 months after procedure

Secondary Outcomes (2)

• Recurrent CBD Stones

  Over 6months after procedure

• Cholangitis

  Over 6months after procedure

Study Arms (1)

Normal saline irrigation

EXPERIMENTAL

Procedure: Normal Saline Irrigation

Interventions

Normal Saline Irrigation PROCEDURE

After removing CBD stones with the ERCP, 200ml of the normal saline solution was irrigated into the common bile duct.

Normal saline irrigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seoungnam, Gyeonggi-do, 463-707, South Korea

RECRUITING

Related Publications (17)

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  PMID: 7492013 BACKGROUND

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  PMID: 16858527 BACKGROUND

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  PMID: 18554235 BACKGROUND

• Ang TL, Teo EK, Fock KM, Lyn Tan JY. Are there roles for intraductal US and saline solution irrigation in ensuring complete clearance of common bile duct stones? Gastrointest Endosc. 2009 Jun;69(7):1276-81. doi: 10.1016/j.gie.2008.10.018. Epub 2009 Feb 26.

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  PMID: 16921297 BACKGROUND

• Ahn DW, Lee SH, Paik WH, Song BJ, Park JM, Kim J, Jeong JB, Hwang JH, Ryu JK, Kim YT. Effects of Saline Irrigation of the Bile Duct to Reduce the Rate of Residual Common Bile Duct Stones: A Multicenter, Prospective, Randomized Study. Am J Gastroenterol. 2018 Apr;113(4):548-555. doi: 10.1038/ajg.2018.21. Epub 2018 Mar 27.

  PMID: 29610513 DERIVED

Related Links

• Seoul National University Bundang Hospital
• Seoul National University College of Medicine
• Korea Food and Drug Administration

MeSH Terms

Conditions

Gallstones

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Sang Hyub Lee, M.D. Ph.D

  Department of Internal Medicine, Seoul National University Bundang Hospital

  STUDY DIRECTOR

• Sang Eon Jang, M.D.

  Department of Internal Medicine, Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sang Eon Jang, M.D

CONTACT

+82-10-7479-6271; medimax2@naver.com

Sang Hyup Lee, M.D. Ph.D

CONTACT

+82-10-8708-6267; gidoctor@snubh.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Internal Medicine, Seoul National University Bundang Hospital

Study Record Dates

• First Submitted: August 26, 2011
• First Posted: August 29, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 29, 2011

Record last verified: 2011-08

Locations

KR (1)