CholedocholithiasisNCT00124033
Management of Common Bile Duct (CBD) Stones at Laparoscopic Cholecystectomy
A study testing Transcystic Stenting (Facilitated ERCP) in people with Choledocholithiasis and Cholelithiasis, run by South West Sydney Local Health District at 13 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Choledocholithiasis, Cholelithiasis
- What is being tested?
- Transcystic Stenting (Facilitated ERCP)
- Type of treatment
- Surgery or procedure
- How many people
- 340 participants
- Where
- 13 sitesAustralia
- Study dates
- Mar 2004to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Australia13 sites
Bankstown-Lidcombe Hospital
Bankstown, New South Wales, 2200
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Dubbo Base Hospital
Dubbo, New South Wales, 2830
Gosford Hospital
Gosford, New South Wales, 2250
Blue Mountains District ANZAC Memorial Hospital
Katoomba, New South Wales, 2780
Nepean Hospital
Kingswood, New South Wales, 2747
St George Hospital
Kogarah, New South Wales, 2217
Liverpool Hospital
Liverpool, New South Wales, 2170
John Hunter Hospital
New Lambton, New South Wales, 2300
Prince of Wales Hospital
Randwick, New South Wales, 2031
Royal North Shore Hospital
St Leonards, New South Wales, 2065
Westmead Hospital
Westmead, New South Wales, 2145
Hawkesbury District Health Service
Windsor, New South Wales, 2756
About this study
Official 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
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.
Read the detailed description
Symptomatic gallstone disease is common. In the year July 2001-2002, laparoscopic cholecystectomy was performed on 5,235 patients in NSW public hospitals. Up to 18% of patients undergoing laparoscopic cholecystectomy for gallstones may have concomitant common bile duct stones (choledocholithiasis). Twenty-five percent of bile duct stones are completely unsuspected. Therefore the optimal management of bile duct stones is a significant issue for all general surgeons who perform this very common operation. Yet, the management of these patients in the laparoscopic era remains contentious.
Prior to the laparoscopic era cholecystectomy patients with bile duct stones were managed surgically during open cholecystectomy (OC), with direct exploration of their common bile duct (choledochotomy). However, open surgical bile duct exploration waned in popularity and progressively stones were dealt with endoscopically, either pre or post cholecystectomy. As laparoscopic technology advances, simultaneous clearance of the bile duct at the time of laparoscopic cholecystectomy is regaining popularity.
Some surgeons elect to remove bile duct stones at the index operation through the cystic duct. This approach has a success rate of between 75 and 90%. When there is failure to clear the bile duct transcystically, some surgeons proceed to a choledochotomy to clear the duct, while others close the cystic duct stump, leaving the stones in situ to be removed at a later date by endoscopic retrograde cholangiopancreatography (ERCP) and sphincterotomy. The argument in favour of immediate choledochotomy is that the duct may be cleared in one sitting. The argument against it is that the morbidity of choledochotomy is considerable. The argument for a subsequent ERCP is that the morbidity of choledochotomy is avoided. The argument against subsequent ERCP is that there may be difficulty cannulating the common bile duct and that ERCP with sphincterotomy is associated with a significant morbidity, particularly pancreatitis.
An alternative approach taken by the majority of surgeons in NSW when confronted by common bile duct stones at laparoscopic cholecystectomy is to close the cystic duct stump in all patients, without exploring the duct transcystically. Stones are left in situ, to be removed at a later date endoscopically - by ERCP and sphincterotomy. The attendant risks of this approach are mentioned above.
Another approach is to facilitate the performance of post-operative ERCP and sphincterotomy by inserting a stent transcystically at the time of laparoscopic cholecystectomy. Facilitated ERCP has recently been reported in a prospective consecutive series from Nepean Hospital. Failure to access the common bile duct at first attempt was 1.2% in this series, which compares favourably with duct access failure rates - reported in the literature - of 5-12% without the facilitation of a stent. The incidence of pancreatitis, bleeding and duodenal perforation after facilitated ERCP was 0%, 0% and 0.6%, respectively. Two cases (1.2%) of cholangitis were also reported. Comparison to other series suggests that facilitated ERCP offers real advantages over the conventional unfacilitated ERCP for bile duct stone removal, which has a reported pancreatitis rate of 2-11% (and our own rate of 8%); a bleeding rate of 2-4 % and a duodenal perforation rate of 1-4%. The mortality rates of these ERCP techniques cannot be compared at this preliminary stage because of insufficient numbers in the Nepean series.
- Conditions
- Choledocholithiasis, Cholelithiasis
- Being tested
- Transcystic Stenting (Facilitated ERCP)
- Keywords
- Cholecystectomy, Cholangiopancreatography, Endoscopic Retrograde
- Medical subject headings
- Choledocholithiasis, Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcystic Stenting (Facilitated ERCP)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of facilitated ERCP compared to conventional unfacilitated ERCP - as assessed by the incidence of pancreatitis post ERCP
Secondary outcomes (9)
The success rate and morbidity of transcystic exploration for common bile duct stone removal across a broad spectrum of surgeons
The success rate of transcystic stent placement across a broad spectrum of surgeons
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
Hospitalisation time according to treatment group
The incidence of hyperamylasemia after transcystic exploration of the common bile duct, transcystic insertion of a stent or transcystic cholangiography alone
The success rate and complications after choledochotomy for common bile duct stones
The failure rate of selective common bile duct cannulation for facilitated ERCP as compared to conventional ERCP
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
Long-term efficacy of techniques used to remove common bile duct stones, as measured by the recurrence of stones in the bile duct
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2005 (estimated)
- Study startMar 2004
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CholedocholithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 340 participants
Sponsor and investigators
- Lead sponsor
- South West Sydney Local Health District
- Sponsor type
- University, hospital or other
- Collaborators
- Catholic Health Care Services, Greater Western Area Health Service, Hunter New England Area Health Service, Northern Sydney and Central Coast Area Health Service, South Eastern Area Health Service, Sydney South West Area Health Service
- Investigators
- Christopher J Martin, MBBS MSc, Principal investigator, Sydney West Area Health Service (Department of Surgery, Nepean Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00124033
- Sponsor's protocol ID
- 04/001
- Status last verified
- Jun 2005
- First submitted
- 25 Jul 2005
- Last updated
- 11 Sep 2006
- Results posted
- No
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.
PubMed 11982511
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00124033
- Acronym / sponsor ID
- 04/001
- Conditions
- Choledocholithiasis, Cholelithiasis
- Keywords
- Cholecystectomy, Cholangiopancreatography, Endoscopic Retrograde
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 340 participants
- Lead sponsor
- South West Sydney Local Health DistrictUniversity, hospital or other
- Collaborators
- Catholic Health Care Services, Greater Western Area Health Service, Hunter New England Area Health Service, Northern Sydney and Central Coast Area Health Service, South Eastern Area Health Service, Sydney South West Area Health Service
- Study start
- Mar 2004
- Study completion
- Dec 2015
- First posted
- 26 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Symptomatic gallstone disease is common. In the year July 2001-2002, laparoscopic cholecystectomy was performed on 5,235 patients in NSW public hospitals. Up to 18% of patients undergoing laparoscopic cholecystectomy for gallstones may have concomitant common bile duct stones (choledocholithiasis). Twenty-five percent of bile duct stones are completely unsuspected. Therefore the optimal management of bile duct stones is a significant issue for all general surgeons who perform this very common operation. Yet, the management of these patients in the laparoscopic era remains contentious.
Prior to the laparoscopic era cholecystectomy patients with bile duct stones were managed surgically during open cholecystectomy (OC), with direct exploration of their common bile duct (choledochotomy). However, open surgical bile duct exploration waned in popularity and progressively stones were dealt with endoscopically, either pre or post cholecystectomy. As laparoscopic technology advances, simultaneous clearance of the bile duct at the time of laparoscopic cholecystectomy is regaining popularity.
Some surgeons elect to remove bile duct stones at the index operation through the cystic duct. This approach has a success rate of between 75 and 90%. When there is failure to clear the bile duct transcystically, some surgeons proceed to a choledochotomy to clear the duct, while others close the cystic duct stump, leaving the stones in situ to be removed at a later date by endoscopic retrograde cholangiopancreatography (ERCP) and sphincterotomy. The argument in favour of immediate choledochotomy is that the duct may be cleared in one sitting. The argument against it is that the morbidity of choledochotomy is considerable. The argument for a subsequent ERCP is that the morbidity of choledochotomy is avoided. The argument against subsequent ERCP is that there may be difficulty cannulating the common bile duct and that ERCP with sphincterotomy is associated with a significant morbidity, particularly pancreatitis.
An alternative approach taken by the majority of surgeons in NSW when confronted by common bile duct stones at laparoscopic cholecystectomy is to close the cystic duct stump in all patients, without exploring the duct transcystically. Stones are left in situ, to be removed at a later date endoscopically - by ERCP and sphincterotomy. The attendant risks of this approach are mentioned above.
Another approach is to facilitate the performance of post-operative ERCP and sphincterotomy by inserting a stent transcystically at the time of laparoscopic cholecystectomy. Facilitated ERCP has recently been reported in a prospective consecutive series from Nepean Hospital. Failure to access the common bile duct at first attempt was 1.2% in this series, which compares favourably with duct access failure rates - reported in the literature - of 5-12% without the facilitation of a stent. The incidence of pancreatitis, bleeding and duodenal perforation after facilitated ERCP was 0%, 0% and 0.6%, respectively. Two cases (1.2%) of cholangitis were also reported. Comparison to other series suggests that facilitated ERCP offers real advantages over the conventional unfacilitated ERCP for bile duct stone removal, which has a reported pancreatitis rate of 2-11% (and our own rate of 8%); a bleeding rate of 2-4 % and a duodenal perforation rate of 1-4%. The mortality rates of these ERCP techniques cannot be compared at this preliminary stage because of insufficient numbers in the Nepean series.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcystic Stenting (Facilitated ERCP) | Procedure or surgery | – |
Primary outcome
Safety of facilitated ERCP compared to conventional unfacilitated ERCP - as assessed by the incidence of pancreatitis post ERCP
9 secondary outcomes
The success rate and morbidity of transcystic exploration for common bile duct stone removal across a broad spectrum of surgeons
The success rate of transcystic stent placement across a broad spectrum of surgeons
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
Hospitalisation time according to treatment group
The incidence of hyperamylasemia after transcystic exploration of the common bile duct, transcystic insertion of a stent or transcystic cholangiography alone
The success rate and complications after choledochotomy for common bile duct stones
The failure rate of selective common bile duct cannulation for facilitated ERCP as compared to conventional ERCP
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
Long-term efficacy of techniques used to remove common bile duct stones, as measured by the recurrence of stones in the bile duct
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2006.
- Background: PubMed 11982511Martin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher J Martin, MBBS MSc principal investigator
Sydney West Area Health Service (Department of Surgery, Nepean Hospital)
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcystic Stenting (Facilitated ERCP) in people with Choledocholithiasis and Cholelithiasis, run by South West Sydney Local Health District at 13 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of facilitated ERCP compared to conventional unfacilitated ERCP - as assessed by the incidence of pancreatitis post ERCP. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00124033, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2006.