Common Bile Duct StonesCBDSNCT02155244
Common Bile Duct Stone Management: What Have we Learned?
An observational study of Common Bile Duct Stones, run by Ospedale Regionale di Mendrisio.
Trial summary
In unfit elderly people with comorbid disease leaving the gallbladder in situ is justified after ERCP treatment. Cholangitis is more present in elderly people. The purpose of this study is to determine leaving the gallbladder in situ does not reduce the morbidity rate after ERCP for common bile duct stones(CBDS)… Read more about this study
- Who is it for?
- Ages 18 to 94 years
- Conditions the study is for
- Common Bile Duct Stones
- How many people
- 101 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to May 2014
- 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 to 94 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- Patients with common bile duct stones (CBDS)
Who cannot join
None listed.
About this study
In unfit elderly people with comorbid disease leaving the gallbladder in situ is justified after ERCP treatment. Cholangitis is more present in elderly people. The purpose of this study is to determine leaving the gallbladder in situ does not reduce the morbidity rate after ERCP for common bile duct stones(CBDS), especially in patients with cholangitis.
Read the detailed description
The prevalence of gallstone disease increases with age, and as many as one third of women and one fifth of men over the age of 60 years have gallstones. The quoted prevalence of CBDS in patients with symptomatic gallstones varies, but probably lies between 10 and 20%. In Europe and Northern America 8 to 20% of cases of cholelithiasis is complicated by presence of common bile duct stones (CBDS) during cholecystectomy. When ductal stones do become symptomatic the consequences are often serious and can include pain, partial or complete biliary obstruction, cholangitis, hepatic abscesses or pancreatitis. Recent guidelines for the treatment of CBDS recommend that in patients with symptoms and clinical evaluation suggesting ductal stones as a cause, stones should be extracted if possible, except in selected patients that have contraindications (e.g high risks patients, refusal of endoscopic or operative treatment).
Many different approaches are currently being used for the management of bile duct calculi. These strategies differ considerably in terms of technical complexity, sensitivity, specificity, effectiveness, and cost. Where initial assessment suggests a high probability of CBDS, then it is reasonable to proceed directly to ERCP if this is considered the treatment of choice. Intraoperative cholangiography with selective intraoperative or postoperative ERCP is a strategy than routine preoperative ERCP, unless the presence of common bile duct stones (CBD) is almost certain. Current data does not suggest clear superiority of any one approach with regard success, mortality, morbidity and cost-effectiveness. In unfit elderly people with comorbid disease leaving the gallbladder in situ is justified after ERCP treatment. Cholangitis is more present in elderly people. Leaving the gallbladder in situ does not reduce the morbidity rate after ERCP for CBDS, especially in patients with cholangitis
All 101 patients with symptomatic and suspected CBD stones admitted to Surgical Department of "Ospedale Regionale di Mendrisio" from january 2006 to december 2013 were evaluated retrospectively for study eligibility. Patients were followed for the duration of hospital stay, the median hospital stay was 9 days.
From our Hospital informatic system, information on age, sex, length of hospital stay, and procedures undertaken during hospital admissions for patients with biliary diagnoses were retrieved. Initial patient evaluations consisted of history and physical examinations and serum analyses for inflammatory parameters, bilirubin, alkaline phosphatase, transaminase, and amylase. Previous history of jaundice or acute pancreatitis was recorded. In addition, right upper quadrant abdominal sonograms and CT scan were obtained for the determination of cholelithiasis and CBD diameter. The diagnosis of cholangitis was based on presence of clinical evidence of infection in patients with biliary obstruction in the form of jaundice or hyperbilirubinemia.
In our institution, patients with cholelithiasis, a CBD stones at US examination, and liver enzyme elevation, without clinical evidence of cholecystitis or biliary pancreatitis underwent ERCP, endoscopic sphincterotomy, and endoscopic clearance of CBD stones before laparoscopic cholecystectomy (LC). In patients with acute cholangitis, a dilated common bile duct on US, the first treatment was also ERCP. Patients with cholelithiasis, CBD and intrahepatic bile duct (IHBD) dilatation, and liver enzyme elevation, in the presence of cholecystitis, biliary pancreatitis, or apparent resolving symptomatic choledocholithiasis underwent further evaluation with magnetic resonance imaging(MR), and these patients underwent therapeutic ERCP when choledocholithiasis was demonstrated by MR, whereas patients whose MR did not detect choledocholithiasis underwent LC with intraoperative cholangiography (IOC). When we found CBD during LC, an ERCP was performed in the same operating time ("rendez-vous") or post operatively.
Endoscopic retrograde cholangiopancreatography(ERCP) with papillotomy was performed in patients with confirmed common bile duct stones(CBDS) by a single gastroenterologist.
In our Hospital, the procedure is performed in radiological room that contains x-ray equipment. We use a Olympus® duodenalendoscope TJF-145 for ERCP, Erbe® system for papillotomy diathermy, and Lithotriptor® if stone crushing is necessary. The patient is in prone position under general anesthesia. When performing endoscopic stone extraction the endoscopist has the support of a technician or radiologist who can assist in fluoroscopic screening and an additional endoscopy assistant/nurse to manage guide wires.
The relationship between ERCP and surgery was assessed by dividing the patients into 2 groups: patients who had ERCP without cholecystectomy (Group 1), patients who had ERCP + cholecystectomy (Group 2). Endpoint was to detect difference in age, indication (cholangitis and lithiasis), morbidity, effectiveness and success of CBD clearance in different groups.
- Conditions
- Common Bile Duct Stones
- Keywords
- CBDS, ERCP, Dindo-Clavien classification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Common bile duct stones | Common bile duct stones traeted with ERCP | |
| CBDS | treated with ERCP combined with surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative complications according to Clavien-Dindo classification
Measured: During patients hospitalization (median hospital stay was 9 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study startJan 2006
- Primary completionJan 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common Bile Duct StonesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Regionale di Mendrisio
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Regusci, Ospedale Regionale di Mendrisio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02155244
- Sponsor's protocol ID
- LR-1234
- Acronym
- CBDS
- Status last verified
- Jun 2014
- First submitted
- 19 May 2014
- Last updated
- 4 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Common Bile Duct Stone Management: What Have we Learned?
- ClinicalTrials.gov ID
- NCT02155244
- Acronym / sponsor ID
- CBDS / LR-1234
- Conditions
- Common Bile Duct Stones
- Keywords
- CBDS, ERCP, Dindo-Clavien classification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Ospedale Regionale di MendrisioUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jan 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 4 Jun 2014 (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.
In unfit elderly people with comorbid disease leaving the gallbladder in situ is justified after ERCP treatment. Cholangitis is more present in elderly people. The purpose of this study is to determine leaving the gallbladder in situ does not reduce the morbidity rate after ERCP for common bile duct stones(CBDS), especially in patients with cholangitis.
Detailed description
The prevalence of gallstone disease increases with age, and as many as one third of women and one fifth of men over the age of 60 years have gallstones. The quoted prevalence of CBDS in patients with symptomatic gallstones varies, but probably lies between 10 and 20%. In Europe and Northern America 8 to 20% of cases of cholelithiasis is complicated by presence of common bile duct stones (CBDS) during cholecystectomy. When ductal stones do become symptomatic the consequences are often serious and can include pain, partial or complete biliary obstruction, cholangitis, hepatic abscesses or pancreatitis. Recent guidelines for the treatment of CBDS recommend that in patients with symptoms and clinical evaluation suggesting ductal stones as a cause, stones should be extracted if possible, except in selected patients that have contraindications (e.g high risks patients, refusal of endoscopic or operative treatment).
Many different approaches are currently being used for the management of bile duct calculi. These strategies differ considerably in terms of technical complexity, sensitivity, specificity, effectiveness, and cost. Where initial assessment suggests a high probability of CBDS, then it is reasonable to proceed directly to ERCP if this is considered the treatment of choice. Intraoperative cholangiography with selective intraoperative or postoperative ERCP is a strategy than routine preoperative ERCP, unless the presence of common bile duct stones (CBD) is almost certain. Current data does not suggest clear superiority of any one approach with regard success, mortality, morbidity and cost-effectiveness. In unfit elderly people with comorbid disease leaving the gallbladder in situ is justified after ERCP treatment. Cholangitis is more present in elderly people. Leaving the gallbladder in situ does not reduce the morbidity rate after ERCP for CBDS, especially in patients with cholangitis
All 101 patients with symptomatic and suspected CBD stones admitted to Surgical Department of "Ospedale Regionale di Mendrisio" from january 2006 to december 2013 were evaluated retrospectively for study eligibility. Patients were followed for the duration of hospital stay, the median hospital stay was 9 days.
From our Hospital informatic system, information on age, sex, length of hospital stay, and procedures undertaken during hospital admissions for patients with biliary diagnoses were retrieved. Initial patient evaluations consisted of history and physical examinations and serum analyses for inflammatory parameters, bilirubin, alkaline phosphatase, transaminase, and amylase. Previous history of jaundice or acute pancreatitis was recorded. In addition, right upper quadrant abdominal sonograms and CT scan were obtained for the determination of cholelithiasis and CBD diameter. The diagnosis of cholangitis was based on presence of clinical evidence of infection in patients with biliary obstruction in the form of jaundice or hyperbilirubinemia.
In our institution, patients with cholelithiasis, a CBD stones at US examination, and liver enzyme elevation, without clinical evidence of cholecystitis or biliary pancreatitis underwent ERCP, endoscopic sphincterotomy, and endoscopic clearance of CBD stones before laparoscopic cholecystectomy (LC). In patients with acute cholangitis, a dilated common bile duct on US, the first treatment was also ERCP. Patients with cholelithiasis, CBD and intrahepatic bile duct (IHBD) dilatation, and liver enzyme elevation, in the presence of cholecystitis, biliary pancreatitis, or apparent resolving symptomatic choledocholithiasis underwent further evaluation with magnetic resonance imaging(MR), and these patients underwent therapeutic ERCP when choledocholithiasis was demonstrated by MR, whereas patients whose MR did not detect choledocholithiasis underwent LC with intraoperative cholangiography (IOC). When we found CBD during LC, an ERCP was performed in the same operating time ("rendez-vous") or post operatively.
Endoscopic retrograde cholangiopancreatography(ERCP) with papillotomy was performed in patients with confirmed common bile duct stones(CBDS) by a single gastroenterologist.
In our Hospital, the procedure is performed in radiological room that contains x-ray equipment. We use a Olympus® duodenalendoscope TJF-145 for ERCP, Erbe® system for papillotomy diathermy, and Lithotriptor® if stone crushing is necessary. The patient is in prone position under general anesthesia. When performing endoscopic stone extraction the endoscopist has the support of a technician or radiologist who can assist in fluoroscopic screening and an additional endoscopy assistant/nurse to manage guide wires.
The relationship between ERCP and surgery was assessed by dividing the patients into 2 groups: patients who had ERCP without cholecystectomy (Group 1), patients who had ERCP + cholecystectomy (Group 2). Endpoint was to detect difference in age, indication (cholangitis and lithiasis), morbidity, effectiveness and success of CBD clearance in different groups.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Common bile duct stones | – | –Common bile duct stones traeted with ERCP |
| CBDS | – | –treated with ERCP combined with surgery |
Who may qualify
- Ages
- 18 to 94 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (1 listed)
- Patients with common bile duct stones (CBDS)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Post-operative complications according to Clavien-Dindo classification
Time frame: During patients hospitalization (median hospital stay was 9 days)
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 4 Jun 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Common Bile Duct Stones, run by Ospedale Regionale di Mendrisio.
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 1 inclusion and 0 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 4 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Post-operative complications according to Clavien-Dindo classification (time frame: During patients hospitalization (median hospital stay was 9 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2014.