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

NCT01425177 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2011-08-29

No results posted yet for this study

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

Interventions

PROCEDURE

Normal Saline Irrigation

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

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Sang Hyub Lee, M.D. Ph.D · Department of Internal Medicine, Seoul National University Bundang Hospital

  • Sang Eon Jang, M.D. · Department of Internal Medicine, Seoul National University Bundang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • South Korea

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01425177 on ClinicalTrials.gov