Trial registered on ANZCTR


Trial ID
ACTRN12605000040662
Ethics application status
Approved
Date submitted
25/07/2005
Date registered
25/07/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Management of 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] 91 0
04/001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Choledocholithiasis 106 0
Condition category
Condition code
Oral and Gastrointestinal 125 125 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
Facilitated' (placement of a stent at the time of laparoscopic cholecystectomy) endoscopic retrograde cholangiopancreatography (ERCP).
Intervention code [1] 56 0
Treatment: Other
Comparator / control treatment
Conventional ERCP - for the removal of stones found in the bile duct at the time of laparoscopic cholecystectomy.
Control group
Active

Outcomes
Primary outcome [1] 157 0
Safety of facilitated ERCP compared to conventional unfacilitated ERCP
Timepoint [1] 157 0
Assessed by the incidence of pancreatitis post ERCP
Secondary outcome [1] 345 0
The success rate and morbidity of transcystic exploration for common bile duct stone removal across a broad spectrum of surgeons.
Timepoint [1] 345 0
Secondary outcome [2] 346 0
The success rate of transcystic stent placement across a broad spectrum of surgeons.
Timepoint [2] 346 0
Secondary outcome [3] 347 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] 347 0
Secondary outcome [4] 348 0
Hospitalisation time according to treatment group.
Timepoint [4] 348 0
Secondary outcome [5] 349 0
The incidence of hyperamylasemia after transcystic exploration of the common bile duct, transcystic insertion of a stent or transcystic cholangiography alone.
Timepoint [5] 349 0
Secondary outcome [6] 350 0
The success rate and complications after choledochotomy for common bile duct stones.
Timepoint [6] 350 0
Secondary outcome [7] 351 0
The failure rate of selective common bile duct cannulation for facilitated ERCP as compared to conventional ERCP.
Timepoint [7] 351 0
Secondary outcome [8] 352 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] 352 0
Secondary outcome [9] 353 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] 353 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: a CBD stone identified at ultrasound; a wide CBD (>6mm) at ultrasound; previous, recent, current cholangitis, jaundice, or biliary pancreatitis; abnormal AST and ALT levels (>2 times normal).
Minimum age
Not stated
Maximum age
No limit
Gender
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; those in whom intervention was not technically possible (eg. previous Billroth II gastrectomy).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central Telephone Number - random allocation once common bile duct stones are identified at operative cholangiogram.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence was generated with a computer program, in blocks. Patients are stratified at the time of randomisation according to whether or not the surgeon attempted to explore the common bile duct transcystically but failed to clear it.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
Actual
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)

Funding & Sponsors
Funding source category [1] 172 0
Self funded/Unfunded
Name [1] 172 0
Address [1] 172 0
Country [1] 172 0
Primary sponsor type
Government body
Name
Sydney West Area Health Service
Address
Country
Australia
Secondary sponsor category [1] 124 0
Government body
Name [1] 124 0
Catholic Health Care Service
Address [1] 124 0
Country [1] 124 0
Australia
Secondary sponsor category [2] 125 0
Government body
Name [2] 125 0
Greater Western Area Health Service
Address [2] 125 0
Country [2] 125 0
Secondary sponsor category [3] 126 0
Government body
Name [3] 126 0
Hunter New England Area Health Service
Address [3] 126 0
Country [3] 126 0
Secondary sponsor category [4] 127 0
Government body
Name [4] 127 0
Northern Sydney/Central Coast Area Health Service
Address [4] 127 0
Country [4] 127 0
Secondary sponsor category [5] 128 0
Government body
Name [5] 128 0
South Eastern Sydney/Illawarra Area Health Service
Address [5] 128 0
Country [5] 128 0
Secondary sponsor category [6] 129 0
Government body
Name [6] 129 0
Sydney South West Area Health Service
Address [6] 129 0
Country [6] 129 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 923 0
Catholic Health Care Service- Hawkesbury District Health Service
Ethics committee address [1] 923 0
Ethics committee country [1] 923 0
Australia
Date submitted for ethics approval [1] 923 0
Approval date [1] 923 0
Ethics approval number [1] 923 0
Ethics committee name [2] 924 0
Greater Western Area Health Service - Dubbo Base Hospital
Ethics committee address [2] 924 0
Ethics committee country [2] 924 0
Australia
Date submitted for ethics approval [2] 924 0
Approval date [2] 924 0
Ethics approval number [2] 924 0
Ethics committee name [3] 925 0
Hunter New England Area Health Service
Ethics committee address [3] 925 0
Ethics committee country [3] 925 0
Australia
Date submitted for ethics approval [3] 925 0
Approval date [3] 925 0
Ethics approval number [3] 925 0
Ethics committee name [4] 926 0
Northern Sydney/Central Coast Area Health Service - Gosford Hospital,
Ethics committee address [4] 926 0
Ethics committee country [4] 926 0
Australia
Date submitted for ethics approval [4] 926 0
Approval date [4] 926 0
Ethics approval number [4] 926 0
Ethics committee name [5] 927 0
Northern Sydney/Central Coast Area Health Service -Royal North Shore Hospital
Ethics committee address [5] 927 0
Ethics committee country [5] 927 0
Australia
Date submitted for ethics approval [5] 927 0
Approval date [5] 927 0
Ethics approval number [5] 927 0
Ethics committee name [6] 928 0
South Eastern Sydney/Illawarra Area Health Service - Prince of Wales Hospital
Ethics committee address [6] 928 0
Ethics committee country [6] 928 0
Australia
Date submitted for ethics approval [6] 928 0
Approval date [6] 928 0
Ethics approval number [6] 928 0
Ethics committee name [7] 929 0
South Eastern Sydney/Illawarra Area Health Service - St George Hospital
Ethics committee address [7] 929 0
Ethics committee country [7] 929 0
Australia
Date submitted for ethics approval [7] 929 0
Approval date [7] 929 0
Ethics approval number [7] 929 0
Ethics committee name [8] 930 0
Sydney South West Area Health Service - Bankstown-Lidcombe Hospital
Ethics committee address [8] 930 0
Ethics committee country [8] 930 0
Australia
Date submitted for ethics approval [8] 930 0
Approval date [8] 930 0
Ethics approval number [8] 930 0
Ethics committee name [9] 931 0
Sydney South West Area Health Service - Liverpool Hospital
Ethics committee address [9] 931 0
Ethics committee country [9] 931 0
Australia
Date submitted for ethics approval [9] 931 0
Approval date [9] 931 0
Ethics approval number [9] 931 0
Ethics committee name [10] 932 0
Sydney South West Area Health Service -Royal Prince Alfred Hospital
Ethics committee address [10] 932 0
Ethics committee country [10] 932 0
Australia
Date submitted for ethics approval [10] 932 0
Approval date [10] 932 0
Ethics approval number [10] 932 0
Ethics committee name [11] 933 0
Sydney West Area Health Service - Blue Mountains District ANZAC Memorial Hospital
Ethics committee address [11] 933 0
Ethics committee country [11] 933 0
Australia
Date submitted for ethics approval [11] 933 0
Approval date [11] 933 0
Ethics approval number [11] 933 0
Ethics committee name [12] 934 0
Sydney West Area Health Service - Nepean Hospital
Ethics committee address [12] 934 0
Ethics committee country [12] 934 0
Australia
Date submitted for ethics approval [12] 934 0
Approval date [12] 934 0
Ethics approval number [12] 934 0
Ethics committee name [13] 935 0
Sydney West Area Health Service - Westmead Hospital
Ethics committee address [13] 935 0
Ethics committee country [13] 935 0
Australia
Date submitted for ethics approval [13] 935 0
Approval date [13] 935 0
Ethics approval number [13] 935 0

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 to remove 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
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35522 0
Address 35522 0
Country 35522 0
Phone 35522 0
Fax 35522 0
Email 35522 0
Contact person for public queries
Name 9245 0
Professor Christopher J Martin
Address 9245 0
Department of Surgery
Nepean Hospital
Level 5 South Block
PO Box 63
Penrith NSW 2751
Country 9245 0
Australia
Phone 9245 0
+61 2 47342608
Fax 9245 0
+61 2 47343432
Email 9245 0
cmartin@mail.usyd.edu.au
Contact person for scientific queries
Name 173 0
Professor Christopher J Martin
Address 173 0
Department of Surgery
Nepean Hospital
Level 5 South Block
PO Box 63
Penrith NSW 2751
Country 173 0
Australia
Phone 173 0
+61 2 47342608
Fax 173 0
+61 2 47343432
Email 173 0
cmartin@mail.usyd.edu.au