Management of Borderline Common Bile Duct Stone

Not Applicable

Completed

• Conditions: Common Bile Duct Stone
• Interventions: Procedure: conservative; Procedure: ERCP

• Registration Number: NCT02460523
• Lead Sponsor: 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.

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 The randomization process will be done using closed envelop method and will be withdrawn by a nurse in the outpatient clinic.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

• Status Verified: 2012-04
• Study Start: 2012-04
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Study First Submitted: 2015-05-22
• Study First Submitted QC: 2015-05-28
• Study First Posted: 2015-06-02
• Last Update Submitted: 2015-07-20
• Last Update Posted: 2015-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conservative	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.
ERCP (endoscopic)	ERCP	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.

Primary Outcome Measures

Name	Time	Method
complete clearance rate of the CBD stones	30 DAYS	complete clearance rate of the CBD stones

Secondary Outcome Measures

Name	Time	Method
overall complications	30 DAYS	pancreatitis
conversion rate during laparoscopic cholecystectomy	1 day	conversion rate during laparoscopic cholecystectomy