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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
Sponsor:
Information provided by (Responsible Party):
Sang Hyub Lee, Seoul National University Hospital

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.


Condition or disease Intervention/treatment Phase
Common Bile Duct Gallstones Procedure: Normal Saline Irrigation Phase 3

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Detailed Description:

CBD stones are defined as the occurrence of stones in the bile ducts. CBD stone usually causes biliary pain and jaundice, whereas obstruction that develops gradually over several months may manifest initially as pruritus or jaundice alone.

Unlike stones in the gallbladder, CBD stones cause symptoms, tend to present as life-threatening complications such as cholangitis and acute pancreatitis. Given its propensity to result in these serious complications, choledocholithiasis warrants treatment in nearly all cases In 2010, guideline for the risk and treatment of choledocholithiasis was published. The most predictive variables seem to be cholangitis, a bilirubin level higher than 1.7 mg/dL, and a dilated CBD on US. The presence of 2 or more of these variables results in a high probability of a CBD stone. Advanced age (older than 55 years), elevation of a liver biochemical test result other than bilirubin, and pancreatitis are less robust predictors for choledocholithiasis.

There are various ways of non invasive imaging diagnosis of CBD stone. The sensitivity of transabdominal US and conventional computed tomography (CT) in the detection of biliary stones is variable, ranging from 20% to 80% and from 23% to 85%, respectively. MRCP had sensitivity 92-93%, specificity 97-98%. Although MRCP is most excellent in diagnosis, the sensitivity is reduced 33-71% at diagnosis of small stones(less than 5mm) An ERCP has traditionally been considered the evaluation of biliary-tract diseases. This modality is very sensitive (90%) and specific (98%) in detecting CBD stone. EUS for the diagnosis of CBD stone reports widely varying sensitivities of 71% to 100% and specificities of 67% to 100%. Some papers report that intraductal ultrasound(IDUS) is very sensitive(97-100%). However, this is expensive and requires the fully-experienced endoscopist, so, it is difficult to use that.

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.

Retained stone is defined as incomplete stone removal during ERCP, otherwise recurrent stone is defined as recurrence stone after complete stone removal. A criterion to distinguish between the two is stones rediscovery time after ERCP stone removal. Typically, bile duct stones found 6 months or more after endoscopic retrograde cholangiopancreatography (ERCP) generally are considered recurrent, as opposed to retained 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.

For this reason, many studies that reduce the residual and recurrence CBD stones have been performed. Before procedures, MRCP, CT and EUS are performed to identify the exact location of stones. Many studies demonstrated that residual stone clearance with ENBD, EUS or IDUS immediately after ERCP stone removal are useful in reducing the recurrence.

However, cholangiogram with ENBD or using EUS after ERCP stone removal increases the duration of hospital stay, cost and the patient's discomfort. Until now, non-invasive, time reduced, cheap and simply way was unknown.

Recently, two different studies were published. Using IDUS could effectively find residual CBD stones that persisted after EST and balloon and basket extraction. Furthermore, normal saline irrigation of CBD after stone removal appeared useful in clearing residual small stones. These procedures could reduce the retained and recurrent stone Another study showed that additional IDUS to confirm complete stone clearance after ERCP with basket stone removal significantly decreases the early recurrence rate of common bile duct stones.

These studies demonstrated that 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 .

However, prospective study that saline irrigation without EUS or IDUS can reduce recurrent CBD stones after ERCP stone removal does not yet. 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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

Arm Intervention/treatment
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.




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


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

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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


Contacts
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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
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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
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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

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
First Posted: August 29, 2011    Key Record Dates
Last Update Posted: August 29, 2011
Last Verified: August 2011
Keywords provided by Sang Hyub Lee, Seoul National University Hospital:
Retained CBD Stones
Recurrent CBD Stones
Additional relevant MeSH terms:
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Gallstones
Cholelithiasis
Biliary Tract Diseases
Digestive System Diseases
Cholecystolithiasis
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical