Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000151932
Ethics application status
Approved
Date submitted
13/01/2020
Date registered
13/02/2020
Date last updated
13/02/2020
Date data sharing statement initially provided
13/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Protocol for choledocholithiasis at emergency surgery
study (ProCESS)
Scientific title
A cohort study to evaluate the protocolised
management of bile duct stones in emergency general
surgery
Secondary ID [1] 300248 0
Nil Known
Universal Trial Number (UTN)
U1111-1246-3961
Trial acronym
ProCESS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
choledocholithiasis
 315809 0
bile duct stones 316073 0
Condition category
Condition code
Surgery 314100 314100 0 0
Surgical techniques
Oral and Gastrointestinal 314344 314344 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Public Health 314345 314345 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A cohort study to evaluate a management protocol for CBD stones within the Acute General
Surgery Unit (AGSU).
Outcome data will be recorded from patients with bile duct stones undergoing emergency
laparoscopic cholecystectomy.

Management of CBD stones:
Laparoscopic bile duct exploration can be considered for all patients irrespective of stone
size and number.
If the surgeon is unwilling or unable to clear the bile duct at the time of cholecystectomy
then further management is determined by stone size and number as well as the presence
of absence of biliary obstruction as evidenced by jaundice (bilirubin >40mmol/litre)

CBD stone size is estimated with reference to an Olsen-Reddick laparoscopic grasper (width
4.5mm).

Group A: Solitary stones < 4.5mm with no biochemical evidence of biliary obstruction
Laparoscopic bile duct exploration or conservative management of CBD stones, at the
discretion of the operating surgeon.

Group B: Stones > 4.5mm, multiple stones or biochemical evidence of biliary obstruction
CBD exploration or transcystic stenting at the discretion of the operating surgeon.
Exploration may be performed via the transcystic (through the cystic duct) or transductal
(via incision into the CBD) route, with or without choledochoscopy. Positioning is checked by
intraoperative x-ray.

With good stent positioning and biliary drainage, patients may be discharged
postoperatively without further investigation or treatment and booked for an elective ERCP.
We expect the elective ERCP to be booked within 4-6 weeks of discharge, and our time of follow up ends after successful bile duct clearance via ERCP.

This protocol will be undertaken in the unit regardless of the study occurring, as this is already in line with standard practice for many of the surgeons.
Intervention code [1] 316520 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322487 0
Cholangitis as defined by the Tokyo Guidelines for Cholangitis.
Diagnosis is made on presence of systemic inflammation, evidence of cholestasis on laboratory tests and evidence of biliary pathology on imaging (either computed topography (CT), magnetic resonance cholangiopancreatography or ultrasound).

Link to Tokyo Guidelines can be found here: https://onlinelibrary.wiley.com/doi/full/10.1002/jhbp.512
Timepoint [1] 322487 0
By time of outpatient ERCP (within 6-8 weeks)
Primary outcome [2] 322488 0
Pancreatitis, as diagnosed by epigastric pain radiating to back with nausea and one of either a.) elevated serum lipase levels or b.) imaging (CT scan) consistent with pancreatic inflammation
Timepoint [2] 322488 0
By time of outpatient ERCP (within 6-8 weeks)
Secondary outcome [1] 378673 0
Length of inpatient hospital stay in days, inclusive of admission and discharge day. Assessed via medical records.
Timepoint [1] 378673 0
This will be assessed retrospectively when all cases are reviewed, after the last patient has completed their ERCP. We anticipate this to be 6-8 weeks after the enrolment of the final patient.
Secondary outcome [2] 378674 0
Total operating time (in hours) of laparoscopic cholecystectomy, including any biliary tract instrumentation. This will be assessed by time in/out of theatre as recorded in our medical records.
Timepoint [2] 378674 0
This will be assessed retrospectively when all cases are reviewed, after the last patient has completed their ERCP. We anticipate this to be 6-8 weeks after the enrolment of the final patient.
Secondary outcome [3] 378675 0
Postoperative complications of laparoscopic cholecystectomy and biliary instrumentation, including bleeding, infection, bile leak and bile duct injury.
This will be assessed by clinician review of all medical records during inpatient stay. Patients will also be clinically assessed via history and exam at their follow up appointment.
Timepoint [3] 378675 0
By time of outpatient ERCP (within 6-8 weeks)
Secondary outcome [4] 378676 0
Rate of bile duct exploration, assessed from operation notes.
Timepoint [4] 378676 0
This outcome is only assessed once, as it is an intra-operative decision. Timepoint is for the time of the study only, so will end at 6-8 review.
Secondary outcome [5] 378677 0
Rate of small solitary stones retained on follow up magnetic resonance cholangiopancreatography (MRCP)
Timepoint [5] 378677 0
2 weeks from original surgery date

Eligibility
Key inclusion criteria
All consecutive patients within unit undergoing emergency laparoscopic cholecystectomy with bile duct stones identified pre or intra-operatively
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy
Age >85 years

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
We performed a power calculation with respect to the primary endpoint of cholangitis in
patients discharged from hospital following cholecystectomy with a biliary stent in place.
We performed a one-way model for one proportion using Minitab 17. To demonstrate that
the rate of cholangitis is less than 10% (hypothesised proportion = 0.9; comparison
proportion = 0.999) with a power of 0.9 at an a-level of 0.05, 30 participants will be required.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
19/11/2019
Date of last participant enrolment
Anticipated
31/03/2020
Actual
Date of last data collection
Anticipated
29/05/2020
Actual
Sample size
Target
30
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15606 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 29006 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 304673 0
Self funded/Unfunded
Name [1] 304673 0
N/A
Country [1] 304673 0
Primary sponsor type
Individual
Name
Rhys Jones FRCS
Address
Monash Medical Centre
246 Clayton Rd, Clayton 3168
Victoria, Australia
Country
Australia
Secondary sponsor category [1] 304981 0
Individual
Name [1] 304981 0
Stacey Chamberlain MBBS
Address [1] 304981 0
Monash Medical Centre
246 Clayton Rd, Clayton VIC 3168
Country [1] 304981 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305094 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 305094 0
Ethics committee country [1] 305094 0
Australia
Date submitted for ethics approval [1] 305094 0
Approval date [1] 305094 0
15/11/2019
Ethics approval number [1] 305094 0
58519

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

Contacts
Principal investigator
Name 99250 0
Dr Stacey Chamberlain
Address 99250 0
Monash Health
Monash Medical Centre
246 Clayton Rd, Clayton VIC Australia 3168
Country 99250 0
Australia
Phone 99250 0
+61 0467904858
Fax 99250 0
Email 99250 0
[email protected]
Contact person for public queries
Name 99251 0
Stacey Chamberlain
Address 99251 0
Monash Health
Monash Medical Centre
246 Clayton Rd, Clayton VIC Australia 3168
Country 99251 0
Australia
Phone 99251 0
+61 0467904858
Fax 99251 0
Email 99251 0
[email protected]
Contact person for scientific queries
Name 99252 0
Stacey Chamberlain
Address 99252 0
Monash Health
Monash Medical Centre
246 Clayton Rd, Clayton VIC Australia 3168
Country 99252 0
Australia
Phone 99252 0
+61 0467904858
Fax 99252 0
Email 99252 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only, all de-identified
When will data be available (start and end dates)?
Immediately following publication, available for 7 years
Available to whom?
Researchers can provide on reasonable request
Available for what types of analyses?
To achieve the aims set out in the proposal
How or where can data be obtained?
Access subject to approval from principal investigator or secondary investigator.
Principal investigator email: [email protected]
Secondary investigator email: [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6405Ethical approval    379048-(Uploaded-13-01-2020-20-54-05)-Study-related document.pdf



Results publications and other study-related documents

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