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

Primary Purpose

Common Bile Duct Gallstones

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Normal Saline Irrigation
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Common Bile Duct Gallstones focused on measuring Retained CBD Stones, Recurrent CBD Stones

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Normal saline irrigation

Arm Description

Outcomes

Primary Outcome Measures

Retained CBD stones
CT or USG Symptomatic choledocholithiasis

Secondary Outcome Measures

Recurrent CBD Stones
CT, USG Symptomatic choledocholithiasis
Cholangitis
- Fever, RUQ pain, Jaundice

Full Information

First Posted
August 26, 2011
Last Updated
August 26, 2011
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01425177
Brief Title
Effect of Saline Irrigation to DEcrease Rate Of Residual Common Bile Duct Stones
Acronym
SIDEROD
Official Title
Effect of Saline Irrigation to Decrease Rate of Residual Common Bile Duct Stones
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Bile Duct Gallstones
Keywords
Retained CBD Stones, Recurrent CBD Stones

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Normal saline irrigation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Normal Saline Irrigation
Intervention Description
After removing CBD stones with the ERCP, 200ml of the normal saline solution was irrigated into the common bile duct.
Primary Outcome Measure Information:
Title
Retained CBD stones
Description
CT or USG Symptomatic choledocholithiasis
Time Frame
From 3 to 6 months after procedure
Secondary Outcome Measure Information:
Title
Recurrent CBD Stones
Description
CT, USG Symptomatic choledocholithiasis
Time Frame
Over 6months after procedure
Title
Cholangitis
Description
- Fever, RUQ pain, Jaundice
Time Frame
Over 6months after procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sang Eon Jang, M.D
Phone
+82-10-7479-6271
Email
medimax2@naver.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sang Hyup Lee, M.D. Ph.D
Phone
+82-10-8708-6267
Email
gidoctor@snubh.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Hyub Lee, M.D. Ph.D
Organizational Affiliation
Department of Internal Medicine, Seoul National University Bundang Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sang Eon Jang, M.D.
Organizational Affiliation
Department of Internal Medicine, Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seoungnam
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Eon Jang, M.D.
Phone
+82-10-7479-6271
Email
medimax2@naver.com
First Name & Middle Initial & Last Name & Degree
Sang Hyub Lee, M.D. Ph.D
Phone
+82-10-8708-6267
Email
gidoctor@snubh.org

12. IPD Sharing Statement

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Links:
URL
http://www.snubh.org/
Description
Seoul National University Bundang Hospital
URL
http://medicine.snu.ac.kr/
Description
Seoul National University College of Medicine
URL
http://www.kfda.go.kr/
Description
Korea Food and Drug Administration

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

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