Management of Borderline Common Bile Duct Stone (CBDS)

Management and Outcome of Borderline Common Bile Duct With Stone

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.

Study Overview

• Status: Completed
• Conditions: Common Bile Duct Stone
• Intervention / Treatment: Procedure: conservative; Procedure: ERCP

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 The randomization process will be done using closed envelop method and will be withdrawn by a nurse in the outpatient clinic.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

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.; 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.	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 Names: 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 Names: G 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complete clearance rate of the CBD stones	complete clearance rate of the CBD stones	30 DAYS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall complications	pancreatitis	30 DAYS
conversion rate during laparoscopic cholecystectomy	conversion rate during laparoscopic cholecystectomy	1 day

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Ayman El Nakeeb, MD, Mansoura University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• mansoura university

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: May 22, 2015
• First Submitted That Met QC Criteria: May 28, 2015
• First Posted (Estimate): June 2, 2015

Study Record Updates

• Last Update Posted (Estimate): July 21, 2015
• Last Update Submitted That Met QC Criteria: July 20, 2015
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Calculi
• Other Study ID Numbers: borderline CBDS