Management of Borderline Common Bile Duct Stone

Management and Outcome of Borderline Common Bile Duct With Stone

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02460523

Acronym

CBDS

Enrollment

Registered

2015-06-02

Start date

2012-04-30

Completion date

2015-03-31

Last updated

2015-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Common Bile Duct Stone

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 The randomization process will be done using closed envelop method and will be withdrawn by a nurse in the outpatient clinic. 1.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.

Interventions

PROCEDUREconservative

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.

PROCEDUREERCP

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026