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/ct2/show/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
Treatment: Surgery - Transcystic Stenting (Facilitated ERCP)

Treatment: Surgery: Transcystic Stenting (Facilitated ERCP)
Intervention code [1] 0 0
Treatment: Surgery
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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
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
Other
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
This study is designed to assess whether a new technique called facilitated endoscopic
retrograde cholangiopancreatography (ERCP) is or is not superior to conventional ERCP for
removing stones found in the bile duct at the time of laparoscopic cholecystectomy. ERCP is
an endoscopic procedure used to facilitate the radiological examination and subsequent
manipulation of the common bile duct (eg. opening it up, which is called sphincterotomy).
Both facilitated and conventional ERCP are performed as a separate procedure after the
initial gallbladder surgery. This is a comparative study of these two techniques in a
randomised clinical trial.

The aim of this randomised clinical trial is to enable surgeons to decide whether placement
of a plastic stent at the time of laparoscopic cholecystectomy will improve the success rate
and safety of subsequent ERCP and sphincterotomy.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00124033
Trial related presentations / publications
Martin CJ, Cox MR, Vaccaro L. Laparoscopic transcystic bile duct stenting in the management of common bile duct stones. ANZ J Surg. 2002 Apr;72(4):258-64. doi: 10.1046/j.1445-2197.2002.02368.x.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00124033