Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Management of Borderline Common Bile Duct Stone (CBDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02460523
Recruitment Status : Completed
First Posted : June 2, 2015
Last Update Posted : July 21, 2015
Sponsor:
Information provided by (Responsible Party):
Ayman El Nakeeb, Mansoura University

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.

Condition or disease Intervention/treatment Phase
Common Bile Duct Stone Procedure: conservative Procedure: ERCP Not Applicable

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 The randomization process will be done using closed envelop method and will be withdrawn by a nurse in the outpatient clinic.

  1. 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.

    1. 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.
    2. 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Management and Outcome of Borderline Common Bile Duct With Stone
Study Start Date : April 2012
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Arm Intervention/treatment
Active Comparator: conservative

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.

  1. 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.
  2. No improvement: the patient will undergo ERCP and then LC.
Procedure: conservative
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.
Other Name: G 1

Active Comparator: ERCP (endoscopic)

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.

Procedure: ERCP
2- Patients in ERCP group will undergo ERCP and wide papillotomy and stone extraction directly then laparoscopic cholecystectomy (LC) within 3 days.
Other Name: G 2




Primary Outcome Measures :
  1. complete clearance rate of the CBD stones [ Time Frame: 30 DAYS ]
    complete clearance rate of the CBD stones


Secondary Outcome Measures :
  1. overall complications [ Time Frame: 30 DAYS ]
    pancreatitis

  2. conversion rate during laparoscopic cholecystectomy [ Time Frame: 1 day ]
    conversion rate during laparoscopic cholecystectomy



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02460523


Sponsors and Collaborators
Mansoura University
Investigators
Layout table for investigator information
Principal Investigator: Ayman El Nakeeb, MD Mansoura University

Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: Ayman El Nakeeb, Gastroenterology surgical center, mansoura university, Mansoura University
ClinicalTrials.gov Identifier: NCT02460523     History of Changes
Other Study ID Numbers: borderline CBDS
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: July 21, 2015
Last Verified: April 2012

Additional relevant MeSH terms:
Layout table for MeSH terms
Gallstones
Cholelithiasis
Biliary Tract Diseases
Digestive System Diseases
Cholecystolithiasis
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical