NCT02460523

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 2, 2015

Completed
Last Updated

July 21, 2015

Status Verified

April 1, 2012

Enrollment Period

2.9 years

First QC Date

May 22, 2015

Last Update Submit

July 20, 2015

Conditions

Common Bile Duct Stone

Outcome Measures

Primary Outcomes (1)

  • complete clearance rate of the CBD stones

    complete clearance rate of the CBD stones

    30 DAYS

Secondary Outcomes (2)

  • overall complications

    30 DAYS

  • conversion rate during laparoscopic cholecystectomy

    1 day

Study Arms (2)

conservative

ACTIVE COMPARATOR

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.

Procedure: conservative

ERCP (endoscopic)

ACTIVE COMPARATOR

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

Interventions

conservativePROCEDURE

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.

Also known as: G 1
conservative
ERCPPROCEDURE

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

Also known as: G 2
ERCP (endoscopic)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 16627230RESULT

  • 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.

    PMID: 16718834RESULT

  • 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.

    PMID: 20645517RESULT

Related Links

MeSH Terms

Conditions

Gallstones

Interventions

Conservative TreatmentCholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsCholangiographyRadiography, AbdominalRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Digestive SystemEndoscopy, Digestive SystemEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Ayman El Nakeeb, MD

    Mansoura University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gastroenterology surgical center, mansoura university

Study Record Dates

First Submitted

May 22, 2015

First Posted

June 2, 2015

Study Start

April 1, 2012

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

July 21, 2015

Record last verified: 2012-04