Skip to main content
OpenTrials
Completed

NCT Number: NCT02460523

Management of Borderline Common Bile Duct 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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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 The randomization process will be done using closed envelop method and will be withdrawn by a nurse in the outpatient clinic.

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

  • CBD diameter less than 10mm.
  • Single or 2 stones in number.
  • Size of stone 5mm or less.
  • Serum bilirubin level less than 10 mg/dl .
  • SGPT, SGOT less than 300.
  • Associated gallbladder stones

Exclusion criteria

  • Previous cholecystectomy.
  • History of acute cholecystitis, pancreatitis, or cholangitis.
  • Previous history of endoscopic sphincterotomy.
  • Unfit patients for cholecystectomy.
  • No gallbladder stones.
  • Patients with altered GIT anatomy.

Treatment and study plan

Conservative

Procedure

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

ERCP

Procedure

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

Primary outcomes

  1. complete clearance rate of the CBD stones

    Time frame: 30 DAYS

    complete clearance rate of the CBD stones

Secondary outcomes

  1. overall complications

    Time frame: 30 DAYS

    pancreatitis

  2. conversion rate during laparoscopic cholecystectomy

    Time frame: 1 day

    conversion rate during laparoscopic cholecystectomy

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Management and Outcome of Borderline Common Bile Duct With Stone

Acronym: CBDS

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 2, 2015
Registry last updated
Jul 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.