LaparoscopicNCT04467710
Laparoscopic Treatment of Common Bile Duct Stones : What Are the Limits and When Should we Call the Endoscopist ?
An observational study of Laparoscopic and Common Bile Duct Stone With Chronic Cholecystitis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The aim of this study was to identify some risk factors of failure of surgical management of common bile duct stones, in our center between 2007 and 2019. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic, Common Bile Duct Stone With Chronic Cholecystitis
- What is being tested?
- Laparoscopic common bile duct exploration.
- Type of treatment
- Surgery or procedure
- How many people
- 222 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2007to 1 Jun 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients aged more than 18, hospitalized in Montpellier University Hospital between 2007 and 2019 requiring a laparoscopic cholecystectomy for symptomatic biliary disease associated to a common bile duct stone highlighted on preoperative imaging or intraoperative cholangiography, which will be treated surgically or endoscopically during the same hospital stay.
Who may be able to join
- More than 18 years old
- Between 2007 and 2019
- Montpellier University Hospital
- Laparoscopic cholecystectomy for symptomatic cholelithiasis associated to common bile duct stones
- Common bile duct stones highlighted on preoperative imaging or intraoperative cholangiography
- Common bile duct stones treated during the same hospital stay surgically or endocopically
Who cannot join
- Laparotomy
- Previous ERCP
- Less than 18 years old
- Lost to follow up
- Lack of data > 10%
- Other surgical procedure associated at the same time
Show all 11Show fewer
- Previous cholecystectomy
- Caroli's disease
- Severe cholangitis or acute pancreatitis
- Pigmentary or hydatic lithiasis
- Laparoscopic cholecystectomy for other indication than symptomatic cholelithiasis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Common Bile Duct Stones in a Laparoscopic Center : What Are the Limits and When Should we Call the Endoscopist ? Observationnal Study Between 2007-2019
The aim of this study was to identify some risk factors of failure of surgical management of common bile duct stones, in our center between 2007 and 2019.
Read the detailed description
Lithiasis disease represents a real public health problem. Indeed, 10% of the general population is asymptomatic carrier of gallbladder stones and among them, 35% will present a symptomatic form which will cause the indication of cholecystectomy. As a result, around 120,000 cholecystectomies are performed per year in France, and around 750,000 in the United States for this indication. Cholecystectomy is therefore the most widely performed procedure in the world. However, in 3 to 20% of cases, common bile duct stones will be associated and to be treated. Different strategies are proposed: a treatment called "all surgical" or an endoscopic treatment (usually a sphincterotomy) before, after or during a cholecystectomy. The investigators defined two groups of patients: one group with success of fully laparoscopic surgical treatment (cholecystectomy and laparoscopic exploration of the common bile duct at the same time), and one group treated by laparoscopic cholecystectomy and management of the common bile duct stone(s) by an ERCP performed intra, per ou postoperatively. The primary outcome was the failure of surgical management, defined as the requirement of ERCP for extraction of common bile duct stones, which permit us to identify risk factors of failure in the fullfil surgical treatment process. The secondary outcome was to study the morbimortality in each group, and length of stay.
- Being tested
- Laparoscopic common bile duct exploration.
- Keywords
- Common bile duct stones, Laparoscopic common bile duct exploration (LCBDE), ERCP, Morbimortality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic common bile duct exploration.Procedure or surgery
Laparoscopic common bile duct exploration. ERCP (Endoscopic Retrograde Cholangiopancreatography) with sphincterotomy : : removal of common bile duct stones trought the cystic duct (transcystically) with a Dormia or a choledoscope, or throught the common bile duct with a choledoscope introduced throught an incision of the common bile duct.
ERCP with sphincterotomy: removal of common bile duct stones throught the duodenal papilla, and a sphincterotomy of the oddi sphincter during the same time.
| Study group | Role | What they receive |
|---|---|---|
| Success of LCBDE | Patients with a fully laparoscopic surgical treatment of common bile duct stones Receives: Procedure: Laparoscopic common bile duct exploration. | |
| Failure of LCBDE | Patients with a laparoscopic cholecystectomy but an endoscopic treatment of common bile duct stone with an ERCP performed intra, per or postoperatively Receives: Procedure: Laparoscopic common bile duct exploration. |
What is being measured
The primary outcome is the main question the study is designed to answer.
morbimortality
Clavien dindo classification
Measured: 1 day
Secondary outcomes (1)
risk factors of total laprascopic treatment failure.
risk factors of total laprascopic treatment failure.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start1 Jan 2007
- Primary completion30 Dec 2019
- Study completion1 Jun 2020
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 LaparoscopicStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Astrid HERRERO, MD, PHD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467710
- Sponsor's protocol ID
- RECHMPL20_0001
- Status last verified
- Jul 2020
- First submitted
- 8 Jul 2020
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Publications
Genet D, Souche R, Roucaute S, Borie F, Millat B, Valats JC, Fabre JM, Herrero A. Upfront Laparoscopic Management of Common Bile Duct Stones: What Are the Risk Factors of Failure? J Gastrointest Surg. 2023 Sep;27(9):1846-1854. doi: 10.1007/s11605-023-05687-9. Epub 2023 Apr 27.
PubMed 37106206
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Common Bile Duct Stones in a Laparoscopic Center : What Are the Limits and When Should we Call the Endoscopist ? Observationnal Study Between 2007-2019
- ClinicalTrials.gov ID
- NCT04467710
- Acronym / sponsor ID
- RECHMPL20_0001
- Keywords
- Common bile duct stones, Laparoscopic common bile duct exploration (LCBDE), ERCP, Morbimortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 13 Jul 2020 (actual)
- 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.
The aim of this study was to identify some risk factors of failure of surgical management of common bile duct stones, in our center between 2007 and 2019.
Detailed description
Lithiasis disease represents a real public health problem. Indeed, 10% of the general population is asymptomatic carrier of gallbladder stones and among them, 35% will present a symptomatic form which will cause the indication of cholecystectomy. As a result, around 120,000 cholecystectomies are performed per year in France, and around 750,000 in the United States for this indication. Cholecystectomy is therefore the most widely performed procedure in the world. However, in 3 to 20% of cases, common bile duct stones will be associated and to be treated. Different strategies are proposed: a treatment called "all surgical" or an endoscopic treatment (usually a sphincterotomy) before, after or during a cholecystectomy. The investigators defined two groups of patients: one group with success of fully laparoscopic surgical treatment (cholecystectomy and laparoscopic exploration of the common bile duct at the same time), and one group treated by laparoscopic cholecystectomy and management of the common bile duct stone(s) by an ERCP performed intra, per ou postoperatively. The primary outcome was the failure of surgical management, defined as the requirement of ERCP for extraction of common bile duct stones, which permit us to identify risk factors of failure in the fullfil surgical treatment process. The secondary outcome was to study the morbimortality in each group, and length of stay.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Success of LCBDE | – | Procedure: Laparoscopic common bile duct exploration.Patients with a fully laparoscopic surgical treatment of common bile duct stones |
| Failure of LCBDE | – | Procedure: Laparoscopic common bile duct exploration.Patients with a laparoscopic cholecystectomy but an endoscopic treatment of common bile duct stone with an ERCP performed intra, per or postoperatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients aged more than 18, hospitalized in Montpellier University Hospital between 2007 and 2019 requiring a laparoscopic cholecystectomy for symptomatic biliary disease associated to a common bile duct stone highlighted on preoperative imaging or intraoperative cholangiography, which will be treated surgically or endoscopically during the same hospital stay.
Key inclusion criteria (6 listed)
- More than 18 years old
- Between 2007 and 2019
- Montpellier University Hospital
- Laparoscopic cholecystectomy for symptomatic cholelithiasis associated to common bile duct stones
- Common bile duct stones highlighted on preoperative imaging or intraoperative cholangiography
Key exclusion criteria (11 listed)
- Laparotomy
- Previous ERCP
- Less than 18 years old
- Lost to follow up
- Lack of data > 10%
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 |
|---|---|---|
| Laparoscopic common bile duct exploration.Laparoscopic common bile duct exploration. ERCP (Endoscopic Retrograde Cholangiopancreatography) with sphincterotomy : : removal of common bile duct stones trought the cystic duct (transcystically) with a Dormia or a choledoscope, or throught the common bile duct with a choledoscope introduced throught an incision of the common bile duct. ERCP with sphincterotomy: removal of common bile duct stones throught the duodenal papilla, and a sphincterotomy of the oddi sphincter during the same time. | Procedure or surgery | Failure of LCBDE, Success of LCBDE |
Primary outcome
morbimortality
Time frame: 1 day
Clavien dindo classification
1 secondary outcome
risk factors of total laprascopic treatment failure.
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Derived from this study: PubMed 37106206Genet D, Souche R, Roucaute S, Borie F, Millat B, Valats JC, Fabre JM, Herrero A. Upfront Laparoscopic Management of Common Bile Duct Stones: What Are the Risk Factors of Failure? J Gastrointest Surg. 2023 Sep;27(9):1846-1854. doi: 10.1007/s11605-023-05687-9. Epub 2023 Apr 27.
- Individual participant dataSharing planned: Undecided. NC
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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.
Astrid HERRERO, MD, PHD study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laparoscopic and Common Bile Duct Stone With Chronic Cholecystitis, run by University Hospital, Montpellier at 1 site in France.
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 6 inclusion and 11 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: finished, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
morbimortality (time frame: 1 day). 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 NCT04467710, 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 3 Sep 2020.