Clinical trial NCT02460523: Management of Borderline Common Bile Duct Stone
Official title: Management and Outcome of Borderline Common Bile Duct With Stone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Common Bile Duct Stone
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-06-02
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 The randomization process will be done using closed envelop method and will be withdrawn by a nurse in the outpatient clinic.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

Eligibility criteria: 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.

Primary outcomes:
measure: complete clearance rate of the CBD stones
timeFrame: 30 DAYS
Secondary outcomes:
measure: overall complications
timeFrame: 30 DAYS
measure: conversion rate during laparoscopic cholecystectomy
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: Mansoura University
name: Ayman El Nakeeb, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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.