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Management of Borderline Common Bile Duct Stone (CBDS)

Primary Purpose

Common Bile Duct Stone

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
conservative
ERCP
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Common Bile Duct Stone

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Inclusion criteria:

  1. CBD diameter less than 10mm.
  2. Single or 2 stones in number.
  3. Size of stone 5mm or less.
  4. Serum bilirubin level less than 10 mg/dl .
  5. SGPT, SGOT less than 300.
  6. Associated gallbladder stones

Exclusion Criteria:

  1. Previous cholecystectomy.
  2. History of acute cholecystitis, pancreatitis, or cholangitis.
  3. Previous history of endoscopic sphincterotomy.
  4. Unfit patients for cholecystectomy.
  5. No gallbladder stones.
  6. Patients with altered GIT anatomy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    conservative

    ERCP (endoscopic)

    Arm Description

    1- Patients in conservative treatment group will receive medical treatment in the form of antibiotics (3rd generation cephalosporine), analgesics (NSAID eg Ibuprofen ) and antispasmodics for 3 days. These patients will be followed up for improvement on the ground of clinical symptoms and serum bilirubin level and abdominal US for CBD stones. Improvement: If the stone spontaneously passes to the duodenum and CBD is clear completely from the stones proved by US, the patient will undergo laparoscopic cholecystectomy (LC) within 3 days. No improvement: the patient will undergo ERCP and then LC.

    2- Patients in ERCP group will undergo ERCP and wide papillotomy and stone extraction directly then laparoscopic cholecystectomy (LC) within 3 days.cholecystectomy (LC) within 3 days. b- No improvement: the patient will undergo ERCP and then LC.

    Outcomes

    Primary Outcome Measures

    complete clearance rate of the CBD stones
    complete clearance rate of the CBD stones

    Secondary Outcome Measures

    overall complications
    pancreatitis
    conversion rate during laparoscopic cholecystectomy
    conversion rate during laparoscopic cholecystectomy

    Full Information

    First Posted
    May 22, 2015
    Last Updated
    July 20, 2015
    Sponsor
    Mansoura University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02460523
    Brief Title
    Management of Borderline Common Bile Duct Stone
    Acronym
    CBDS
    Official Title
    Management and Outcome of Borderline Common Bile Duct With Stone
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2012 (undefined)
    Primary Completion Date
    March 2015 (Actual)
    Study Completion Date
    March 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mansoura University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Evaluation of the best line of treatment of borderline CBD stones associated with gallbladder stones whether by conservative treatment or endoscopic stone extraction as regard complete clearance rate of the CBD stones followed by laparoscopic cholecystectomy. The secondary outcomes are overall complications related to each approach, technical difficulties and conversion rate during laparoscopic cholecystectomy and cost benefit relationship of each line of treatment.
    Detailed Description
    Enrolled patients in the study will be randomized to either conservative treatment or ERCP and stone extraction. The randomization process will be done using closed envelop method and will be withdrawn by a nurse in the outpatient clinic. Patients in conservative treatment group will receive medical treatment in the form of antibiotics, analgesics and antispasmodics for 3 days. These patients will be followed up for improvement on the ground of clinical symptoms and serum bilirubin level and abdominal US for CBD stones. Improvement: If the stone spontaneously passes to the duodenum and CBD is clear completely from the stones proved by US, the patient will undergo laparoscopic cholecystectomy (LC) within 3 days. No improvement: the patient will undergo ERCP and then LC. Patients in ERCP group will undergo ERCP and wide papillotomy and stone extraction directly then laparoscopic cholecystectomy (LC) within 3 days.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Common Bile Duct Stone

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    35 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    conservative
    Arm Type
    Active Comparator
    Arm Description
    1- Patients in conservative treatment group will receive medical treatment in the form of antibiotics (3rd generation cephalosporine), analgesics (NSAID eg Ibuprofen ) and antispasmodics for 3 days. These patients will be followed up for improvement on the ground of clinical symptoms and serum bilirubin level and abdominal US for CBD stones. Improvement: If the stone spontaneously passes to the duodenum and CBD is clear completely from the stones proved by US, the patient will undergo laparoscopic cholecystectomy (LC) within 3 days. No improvement: the patient will undergo ERCP and then LC.
    Arm Title
    ERCP (endoscopic)
    Arm Type
    Active Comparator
    Arm Description
    2- Patients in ERCP group will undergo ERCP and wide papillotomy and stone extraction directly then laparoscopic cholecystectomy (LC) within 3 days.cholecystectomy (LC) within 3 days. b- No improvement: the patient will undergo ERCP and then LC.
    Intervention Type
    Procedure
    Intervention Name(s)
    conservative
    Other Intervention Name(s)
    G 1
    Intervention Description
    1- Patients in conservative treatment group will receive medical treatment in the form of antibiotics (3rd generation cephalosporine), analgesics (NSAID eg Ibuprofen) and antispasmodics for 3 days. These patients will be followed up for improvement on the ground of clinical symptoms and serum bilirubin level and abdominal US for CBD stones.
    Intervention Type
    Procedure
    Intervention Name(s)
    ERCP
    Other Intervention Name(s)
    G 2
    Intervention Description
    2- Patients in ERCP group will undergo ERCP and wide papillotomy and stone extraction directly then laparoscopic cholecystectomy (LC) within 3 days.
    Primary Outcome Measure Information:
    Title
    complete clearance rate of the CBD stones
    Description
    complete clearance rate of the CBD stones
    Time Frame
    30 DAYS
    Secondary Outcome Measure Information:
    Title
    overall complications
    Description
    pancreatitis
    Time Frame
    30 DAYS
    Title
    conversion rate during laparoscopic cholecystectomy
    Description
    conversion rate during laparoscopic cholecystectomy
    Time Frame
    1 day

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Inclusion criteria: CBD diameter less than 10mm. Single or 2 stones in number. Size of stone 5mm or less. Serum bilirubin level less than 10 mg/dl . SGPT, SGOT less than 300. Associated gallbladder stones Exclusion Criteria: Previous cholecystectomy. History of acute cholecystitis, pancreatitis, or cholangitis. Previous history of endoscopic sphincterotomy. Unfit patients for cholecystectomy. No gallbladder stones. Patients with altered GIT anatomy.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ayman El Nakeeb, MD
    Organizational Affiliation
    Mansoura University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16627230
    Citation
    Hungness ES, Soper NJ. Management of common bile duct stones. J Gastrointest Surg. 2006 Apr;10(4):612-9. doi: 10.1016/j.gassur.2005.08.015. No abstract available.
    Results Reference
    result
    PubMed Identifier
    16718834
    Citation
    Freitas ML, Bell RL, Duffy AJ. Choledocholithiasis: evolving standards for diagnosis and management. World J Gastroenterol. 2006 May 28;12(20):3162-7. doi: 10.3748/wjg.v12.i20.3162.
    Results Reference
    result
    PubMed Identifier
    20645517
    Citation
    Samardzic J, Latic F, Kraljik D, Pitlovic V, Mrkovic H, Miskic D, Latic A, Delibegovic S. Treatment of common bile duct stones--is the role of ERCP changed in era of minimally invasive surgery? Med Arh. 2010;64(3):187-8.
    Results Reference
    result
    Links:
    URL
    http://www.mans.edu.eg/
    Description
    mansoura university

    Learn more about this trial

    Management of Borderline Common Bile Duct Stone

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