Management of Borderline Common Bile Duct Stone

Common Bile Duct Stone Clinical Trial

— CBDS  

Official title:

Management and Outcome of Borderline Common Bile Duct With Stone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02460523
• Other study ID #: borderline CBDS
• Status: Completed
• Phase: N/A
• First received: May 22, 2015
• Last updated: July 20, 2015
• Start date: April 2012
• Est. completion date: March 2015

Study information

• Verified date: April 2012
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 The randomization process will be done using closed envelop method and will be withdrawn by a nurse in the outpatient clinic.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Common Bile Duct Stone
• Gallstones

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

References & Publications (3)

Freitas ML, Bell RL, Duffy AJ. Choledocholithiasis: evolving standards for diagnosis and management. World J Gastroenterol. 2006 May 28;12(20):3162-7. Review. — View Citation

Hungness ES, Soper NJ. Management of common bile duct stones. J Gastrointest Surg. 2006 Apr;10(4):612-9. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete clearance rate of the CBD stones	complete clearance rate of the CBD stones	30 DAYS	Yes
Secondary	overall complications	pancreatitis	30 DAYS	Yes
Secondary	conversion rate during laparoscopic cholecystectomy	conversion rate during laparoscopic cholecystectomy	1 day	Yes

External Links

•   mansoura university