Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00124033




Registration number
NCT00124033
Ethics application status
Date submitted
25/07/2005
Date registered
26/07/2005
Date last updated
11/09/2006

Titles & IDs
Public title
Management of Common Bile Duct (CBD) Stones at Laparoscopic Cholecystectomy
Scientific title
Management of CBD Stones at Laparoscopic Cholecystectomy: A NSW Collaborative Prospective Randomised Trial to Assess the Value of Transcystically Inserted CBD Stents to Facilitate Post-Operative ERCP
Secondary ID [1] 0 0
04/001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Choledocholithiasis 0 0
Cholelithiasis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety of facilitated ERCP compared to conventional unfacilitated ERCP - as assessed by the incidence of pancreatitis post ERCP
Timepoint [1] 0 0
Secondary outcome [1] 0 0
The success rate and morbidity of transcystic exploration for common bile duct stone removal across a broad spectrum of surgeons
Timepoint [1] 0 0
Secondary outcome [2] 0 0
The success rate of transcystic stent placement across a broad spectrum of surgeons
Timepoint [2] 0 0
Secondary outcome [3] 0 0
The overall morbidity of post-operative ERCP, with further comparisons of the morbidity of facilitated and conventional ERCP, with and without transcystic exploration of the common bile duct to remove stones
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Hospitalisation time according to treatment group
Timepoint [4] 0 0
Secondary outcome [5] 0 0
The incidence of hyperamylasemia after transcystic exploration of the common bile duct, transcystic insertion of a stent or transcystic cholangiography alone
Timepoint [5] 0 0
Secondary outcome [6] 0 0
The success rate and complications after choledochotomy for common bile duct stones
Timepoint [6] 0 0
Secondary outcome [7] 0 0
The failure rate of selective common bile duct cannulation for facilitated ERCP as compared to conventional ERCP
Timepoint [7] 0 0
Secondary outcome [8] 0 0
Incidence of multiple endoscopic procedures when the common bile duct was not explored at the primary operation and whether or not this is affected by facilitation at ERCP
Timepoint [8] 0 0
Secondary outcome [9] 0 0
Long-term efficacy of techniques used to remove common bile duct stones, as measured by the recurrence of stones in the bile duct
Timepoint [9] 0 0

Eligibility
Key inclusion criteria
* The patient must be able to give informed consent preoperatively (i.e. elective procedures only)
* Patients at higher than normal risk of having CBD stones identified at OC. For example: *CBD stones identified at ultrasound; *Wide CBD (>6mm) at ultrasound; *Previous, recent, current cholangitis, jaundice, or biliary pancreatitis; or *Abnormal AST and ALT levels (>2 times normal).
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnancy at time of surgery
* Patients not fit for surgery. For example: *Those with acute cholecystitis or persistent obstructive jaundice; *Patients who have had a previous ERCP and sphincterotomy; or *Patients in whom intervention was not technically possible (eg. previous Billroth II gastrectomy).

Study design
Purpose of the study
Educational/counselling/training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 0 0
Dubbo Base Hospital - Dubbo
Recruitment hospital [4] 0 0
Gosford Hospital - Gosford
Recruitment hospital [5] 0 0
Blue Mountains District ANZAC Memorial Hospital - Katoomba
Recruitment hospital [6] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [7] 0 0
St George Hospital - Kogarah
Recruitment hospital [8] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [9] 0 0
John Hunter Hospital - New Lambton
Recruitment hospital [10] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [11] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [12] 0 0
Westmead Hospital - Westmead
Recruitment hospital [13] 0 0
Hawkesbury District Health Service - Windsor
Recruitment postcode(s) [1] 0 0
2200 - Bankstown
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2830 - Dubbo
Recruitment postcode(s) [4] 0 0
2250 - Gosford
Recruitment postcode(s) [5] 0 0
2780 - Katoomba
Recruitment postcode(s) [6] 0 0
2747 - Kingswood
Recruitment postcode(s) [7] 0 0
2217 - Kogarah
Recruitment postcode(s) [8] 0 0
2170 - Liverpool
Recruitment postcode(s) [9] 0 0
2300 - New Lambton
Recruitment postcode(s) [10] 0 0
2031 - Randwick
Recruitment postcode(s) [11] 0 0
2065 - St Leonards
Recruitment postcode(s) [12] 0 0
2145 - Westmead
Recruitment postcode(s) [13] 0 0
2756 - Windsor

Funding & Sponsors
Primary sponsor type
Other
Name
South West Sydney Local Health District
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Catholic Health Care Services
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Greater Western Area Health Service
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Hunter New England Area Health Service
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Northern Sydney and Central Coast Area Health Service
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
South Eastern Area Health Service
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Government body
Name [6] 0 0
Sydney South West Area Health Service
Address [6] 0 0
Country [6] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christopher J Martin, MBBS MSc
Address 0 0
Sydney West Area Health Service (Department of Surgery, Nepean Hospital)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00124033