ANZCTR - Registration

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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]

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

bile duct stones

Condition category

Condition code

Surgery

Surgical techniques

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Public Health

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

By time of outpatient ERCP (within 6-8 weeks)

Primary outcome [2]

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]

By time of outpatient ERCP (within 6-8 weeks)

Secondary outcome [1]

Length of inpatient hospital stay in days, inclusive of admission and discharge day. Assessed via medical records.

Timepoint [1]

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]

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]

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]

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]

By time of outpatient ERCP (within 6-8 weeks)

Secondary outcome [4]

Rate of bile duct exploration, assessed from operation notes.

Timepoint [4]

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]

Rate of small solitary stones retained on follow up magnetic resonance cholangiopancreatography (MRCP)

Timepoint [5]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Monash Medical Centre - Clayton campus - Clayton

Recruitment postcode(s) [1]

3168 - Clayton

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

N/A

Address [1]

N/A

Country [1]

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]

Individual

Name [1]

Stacey Chamberlain MBBS

Address [1]

Monash Medical Centre
246 Clayton Rd, Clayton VIC 3168

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash Health Human Research Ethics Committee

Ethics committee address [1]

Monash Medical Centre
246 Clayton Rd, Clayton VIC 3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

15/11/2019

Ethics approval number [1]

58519

Summary

Brief summary

Gallstone disease is very common, and results in a large number of hospital admissions per year. Some patients with gallstones can develop a blockage in their main bile duct due to stones, which can put them at risk of severe infection, jaundice or other problems like pancreatitis.

There are several ways in which surgeons can go about removing the stones from the bile duct, including during surgery or via endoscopy (camera test down the mouth). There is also an option of placing a stent in the bile duct.
There is currently no agreement between surgeons on which of these options is the best.

We have developed a new protocol to determine if patients can be safely sent home after surgery with a bile duct stent, and then return for an endoscopy electively. We aim to prove that this option is safe, and also improves and steamlines the patient experience.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Stacey Chamberlain

Address

Monash Health
Monash Medical Centre
246 Clayton Rd, Clayton VIC Australia 3168

Country

Australia

Phone

+61 0467904858

Fax

stacey.chamberlain@monashhealth.org

Contact person for public queries

Name

Stacey Chamberlain

Address

Monash Health
Monash Medical Centre
246 Clayton Rd, Clayton VIC Australia 3168

Country

Australia

Phone

+61 0467904858

Fax

stacey.chamberlain@monashhealth.org

Contact person for scientific queries

Name

Stacey Chamberlain

Address

Monash Health
Monash Medical Centre
246 Clayton Rd, Clayton VIC Australia 3168

Country

Australia

Phone

+61 0467904858

Fax

stacey.chamberlain@monashhealth.org

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: rhystjones@gmail.com
Secondary investigator email: drstaceychamberlain@gmail.com

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
6405	Ethical approval					379048-(Uploaded-13-01-2020-20-54-05)-Study-related document.pdf

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.

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