Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000761763
Ethics application status
Approved
Date submitted
18/06/2013
Date registered
9/07/2013
Date last updated
29/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intra-operative endoscopic retrograde cholangiopancreatography versus laparoscopic common bile duct exploration for bile duct clearance in patients with choledocholithiasis undergoing emergency laparoscopic cholecystectomy: a randomised trial
Scientific title
Intra-operative endoscopic retrograde cholangiopancreatography versus laparoscopic common bile duct exploration for bile duct clearance in patients with choledocholithiasis undergoing emergency laparoscopic cholecystectomy: a randomised trial
Secondary ID [1] 282702 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Choledocholithasis 289413 0
Condition category
Condition code
Oral and Gastrointestinal 289738 289738 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
Endoscopic retrograde cholangiopancreatography (ERCP) is an endoscopic procedure involving the use of a side-viewing duodenoscope to perform interventions on the biliary tract (bile ducts). These interventions include, but are not limited to: the use of radio-opaque contrast dye to image the bile and pancreatic ducts, the use of sphincterotomes to incise the sphincter of the bile duct (sphincter of Oddi), the use of balloons or basket extraction devices to remove stones, placement of stents for biliary or pancreatic drainage. ERCP is usually performed under fluoroscopic guidance and thus involves radiation exposure.

The procedure usually lasts between 15-60 mins, depending on the experience of the endoscopist.

The study recruitment period is 3 years and duration of follow-up is at least 6 months.
Intervention code [1] 287360 0
Treatment: Surgery
Comparator / control treatment
Laparoscopic common bile duct exploration is a procedure performed at the time of laparoscopic cholecystectomy (keyhole surgery to remove the gallbladder). It involves the use of keyhole surgery instruments to remove stones found in the bile duct.

LCBDE may add an additional 2-3 hours to the operating time of a laparoscopic cholecystectomy, depending on experience of the operator. The operator may also decide at any time to either, a) abandon the procedure in favour of the performance of ERCP therafter, b) convert the procedure to be completed by open surgery, which involves making a larger incision in the abdomen.
Control group
Active

Outcomes
Primary outcome [1] 289827 0
Bile duct clearance

This will be assessed at the time of surgery by the use of either intra-operative cholangiogram or occlusion cholangiogram (if ERCP is performed) to image the bile duct at the end of procedure.
Timepoint [1] 289827 0
At the end of procedure (LCBDE or ERCP)
Primary outcome [2] 297800 0
Retained stones This will be assessed by follow-up calls 3-monthly to determine if the patient has signs/symptoms of retained stones or has presented to a healthcare practitioner for further intervention for retained stones.
Timepoint [2] 297800 0
3-monthly, for a minimum of six months, up to a maximum of three years
Secondary outcome [1] 303327 0
Complication Rate (Morbidity) - Common peri-operative complications result from the use of anaesthesia e.g. heart attack, stroke, DVT. Other procedure specific complications include infections, bleeding, pancreatitis, cholangitis, bile leak.

These will be assessed during inpatient stay by the treating team of doctors/surgeons.

The 3-monthly follow-up calls, up to a maximum of three years, will also aim to determine if complications have arisen after discharge.
Timepoint [1] 303327 0
During procedure, immediately post-procedure (inpatient stay), three-monthly (by follow-up calls, up to a maximum of three years)
Secondary outcome [2] 303328 0
Length of stay - hospital records will be used to determine date of admission and calculated up till discharge from the treating surgeon/team's episode of care (usually to home, but may be to other step-down institutions e.g. hospice)
Timepoint [2] 303328 0
After patient discharge from episode of inpatient stay
Secondary outcome [3] 303329 0
Mortality - patient passes away i.e. death certificate is signed
Timepoint [3] 303329 0
During inpatient stay, patients who fail to answer 3-monthly follow-up calls (up to a maximum of three years) will be marked 'lost to follow-up' and may be retrospectively labelled as 'mortalities' from hospital records

Eligibility
Key inclusion criteria
Patients undergoing emergency laparoscopic cholecystectomy with common bile duct stones demonstrated intra-operatively on cholangiogram
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant women
Children (patients under the age of 18)
Patients with post-surgical anatomy precluding routine endoscopic access to the ampulla of Vater (Billroth II reconstruction, any form of Roux-en-Y reconstruction)
Severe cholangitis [1]
Severe pancreatitis [2]

1. Kiriyama S, Takada T, Strasberg SM, Solomkin JS, Mayumi T, Pitt HA, et al. TG13 guidelines for diagnosis and severity grading of acute cholangitis (with videos). Journal of Hepato-Biliary-Pancreatic Sciences. 2013 Jan 11; 20: 24–34.
2. Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, et al. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2012 Dec 7; 62: 102–111.

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)
Patients are approached for enrolment into trial during routine pre-operative consent-taking. Patients are made aware that trial participation is voluntary and separate from their routine healthcare and participation or non-participation would not otherwise affect the quality of healthcare provided for them.

Allocation concealment would be carried out by means of prepared sealed and signed envelopes containing serial randomisation letters according to a randomisation list generated by a software for simple randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation letters would be prepared according to a randomisation list generated by a software for simple randomisation and placed in sealed and signed envelopes.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Non-blinded study
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
We re-analysed the estimated sample size required for this study based on our own institutional data, published in July 2014[1], which found clearance rates of 63% for laparoscopic common bile duct exploration and 86% for post-operative ERCP.

Using these figures as estimates, to detect an expected 25% difference (a= 0.05, power = 80%) in the rate of duct clearance, 49 patients per arm would be required.

Previous figures suggesting 100 patients per arm were based on findings of a meta-analysis [2] on two-stage (endoscopic common duct clearance and laparoscopic cholecystectomy) vs. one-stage (laparoscopic surgery alone or combined with intra-operative endoscopy) procedures for clearing the bile duct, which we used as estimates for our study (laparoscopic common bile duct clearance vs intra-operative ERCP), however, these figures would represent a slightly different intervention comparison and population to that of our study (emergency laparoscopic cholecystectomy patients with choledocholithiasis).

Thus, in the presence of the available institutional data above, we have revised our target sample size to 49 patients per arm.

1. Poh B, Cashin P, Bowers K, Ackermann T, Tay YK, Dhir A, Croagh A. Management of choledocholithiasis in an emergency cohort undergoing laparoscopic cholecystectomy: a single-centre experience. HPB (Oxford) 2014 July; 16(7): 629–634. Published online 2013 November 7. doi: 10.1111/hpb.12187
2. Alexakis N, Connor S. Meta-analysis of one- vs. two-stage laparoscopic/endoscopic management of common bile duct stones. HPB (Oxford). 2012 Apr; 14(4): 254–259. doi: 10.1111/j.1477-2574.2012.00439.x

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
18/03/2013
Actual
18/03/2013
Date of last participant enrolment
Anticipated
1/06/2015
Actual
12/05/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
104
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1141 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 6988 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 287468 0
Self funded/Unfunded
Name [1] 287468 0
Country [1] 287468 0
Primary sponsor type
Hospital
Name
Department of Upper GI/HPB Surgery, Monash Medical Centre
Address
246 Clayton Road
Clayton, VIC 3168, Australia
Country
Australia
Secondary sponsor category [1] 286212 0
None
Name [1] 286212 0
Address [1] 286212 0
Country [1] 286212 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289444 0
Southern Health HREC B
Ethics committee address [1] 289444 0
Research Directorate
Southern Health
Monash Medical Centre
246 Clayton Road
Clayton, VIC 3168
Ethics committee country [1] 289444 0
Australia
Date submitted for ethics approval [1] 289444 0
Approval date [1] 289444 0
13/03/2013
Ethics approval number [1] 289444 0
Monash Health HREC Ref: 12245B

Summary
Brief summary
Current practice in the management of CBD stones varies widely with most patients receiving either pre­ or post­ operative ERCP. This is a two-­step approach to the management of CBD stones. A one-­step approach to CBD stones exists in the form of open or laparoscopic CBD exploration (either laparoscopic trans­cystic exploration (TCE) or laparoscopic choledochotomy). We aim to assess the practice of performing a single-­step approach to CBD stones by performing either intra-­operative ERCP or LCBDE once a CBD stone is identified.
Trial website
Trial related presentations / publications
Nil to date.
Public notes

Contacts
Principal investigator
Name 40894 0
Mr Benjamin Poh
Address 40894 0
Dept of Upper GI/HPB Surgery
Monash Medical Centre
246 Clayton Road
Clayton, VIC 3168
Country 40894 0
Australia
Phone 40894 0
+61395435311
Fax 40894 0
Email 40894 0
[email protected]
Contact person for public queries
Name 40895 0
Mr Daniel Croagh
Address 40895 0
Dept of Upper GI/HPB Surgery
Monash Medical Centre
246 Clayton Road
Clayton, VIC 3168
Country 40895 0
Australia
Phone 40895 0
+61395435311
Fax 40895 0
Email 40895 0
[email protected]
Contact person for scientific queries
Name 40896 0
Mr Daniel Croagh
Address 40896 0
Dept of Upper GI/HPB Surgery
Monash Medical Centre
246 Clayton Road
Clayton, VIC 3168
Country 40896 0
Australia
Phone 40896 0
+61395435311
Fax 40896 0
Email 40896 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.