Biliary DiseaseNCT04025645
Common Bile Duct Pressures in Patients With and Without Cholelithiasis
An observational study of Biliary Disease, run by Hospital de La Serena.
Trial summary
Objective. To measure the pressures of the common bile duct in patients with and without cholelithiasis and relating them to the presence of pancreatobiliary reflux. Summary Background Data. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Biliary Disease
- What is being tested?
- MEASUREMENT OF COMMON BILE DUCT PRESSURES
- How many people
- 87 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 10 Jul 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with gastric cancer undergoing elective surgery
Who may be able to join
- All patients with normal values of amylase, lipase, and liver function tests measured 24 hours before the intervention
Who cannot join
- Patients previously cholecystectomized
- Patients with clinical, radiological and laboratory evidence of common bile duct stones
About this study
Official title: Common Bile Duct Pressures in Patients With and Without Cholelithiasis: A Cases and Controls Study
Objective. To measure the pressures of the common bile duct in patients with and without cholelithiasis and relating them to the presence of pancreatobiliary reflux.
Summary Background Data. The reflux of pancreatic enzymes into the epithelium of the bile duct and mainly of the gallbladder is an abnormal phenomenon that plays a role in the lithogenesis and carcinogenesis of this epithelium. It has been suggested that the cause of this reflux is the dysfunction of the sphincter of Oddi. Because the pressure of the common bile duct depends on the pressures of the sphincter of Oddi, this dysfunction would be reflected in an increase in the pressure of the common bile duct in patients with cholelithiasis.
Read more
Methods. A prospective case-control study was designed. The universe was constituted by a convenience sample in which all patients undergoing gastrectomy for gastric cancer during 30 months in our institution were included. The primary outcome measure was to establish differences between common bile duct pressures in patients with and without cholelithiasis.
Results. Common bile duct pressures in patients with gallstones showed a significant elevation (Mean 16.9 mmHg) compared to those of patients without gallstones (Mean 3.3 mm Hg) (p<0.0001). These pressures correlated with the values of amylase and lipase in gallbladder bile; higher levels of these enzymes were found in patients with gallstones compared to patients without gallstones (p<0.0001).
Conclusions. Common bile duct pressures in patients with cholelithiasis were significantly elevated above the parameters previously considered normal.
Read the detailed description
A prospective study of cases and controls was designed using a previously validated model for the study of occult pancreatobiliary reflux in patients undergoing gastrectomy for gastric cancer, in which cholecystectomy is routine according to the oncological surgery protocol for gastric cancer of our institution. The study universe was constituted by a convenience sample in which all patients undergoing gastrectomy for gastric cancer during the period between January 2015 and June 2017 the investigators included. All patients included in this study signed a detailed informed consent regarding the interventions to be performed and the objectives of the study.
Cholecystectomy was performed in all patients after the section of the duodenum. Before the manipulation and dissection of the Calot triangle, a sample of 5 to 10 cc of bile was taken directly from the gallbladder. The sample was stored in a sterile tube at room temperature and immediately sent for processing. The technicians of our institutional laboratory that processed the sample did not know the details of the study. The cholecystectomy was then carried out until the cystic was reached and was cut as proximally as possible to the gallbladder. Through the cystic duct, a 4 French feeding tube equivalent to 1.35 mm in diameter (Well Lead®, Hamburg, Germany) was introduced until reaching a distance of 3 cm distal to the junction of the cystic duct and the common bile duct. Once tested for patency, this probe was connected to a standard pressure transducer used to measure intra-arterial pressure (Edwards Lifesciences™, Irvine, California, USA) and this was connected to a B40 monitor (General Electric® Medical Systems, Milwaukee, WI, USA) with the ability, among other functions, to perform pressure measurements in millimeters of mercury. The level of the junction of the cystic duct and the common bile duct was taken as a zero point, as previously described. Once the whole system was irrigated with 0.9% physiological solution and the zero point was established on the monitor with the system closed, the system was opened and pressures were measured. The minimum, maximum and mean pressures were recorded for one minute. After the procedure was completed, the gastrectomy was performed.
- Conditions
- Biliary Disease
- Being tested
- MEASUREMENT OF COMMON BILE DUCT PRESSURES
- Keywords
- Cholelithiasis, Common Bile Duct, Sphincter of Oddi, Amylase, Lipase
- Medical subject headings
- Gallbladder Diseases, Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEASUREMENT OF COMMON BILE DUCT PRESSURESDiagnostic test
THE PRESSURES OF THE COMMON BILE DUCT WERE MEASURED
| Study group | Role | What they receive |
|---|---|---|
| PATIENTS WITH CHOLELITHIASIS | COMMON BILE DUCT PRESSURES WERE MEASURED IN PATIENTS WITH CHOLELITHIASIS Receives: Diagnostic Test: MEASUREMENT OF COMMON BILE DUCT PRESSURES | |
| PATIENTS WITHOUT CHOLELITHIASIS | COMMON BILE DUCT PRESSURES WERE MEASURED IN PATIENTS WITHOUT CHOLELITHIASIS Receives: Diagnostic Test: MEASUREMENT OF COMMON BILE DUCT PRESSURES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Common bile duct pressures
Establish differences between common bile duct pressures in patients with and without gallstones
Measured: Two and a half years
Secondary outcomes (1)
Levels of amylase and lipase in bile
Establish the relationship between these pressure differences and the presence of pancreatobiliary reflux in patients with and without cholelithiasis
Measured: Two and a half years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start1 Jan 2015
- Primary completion30 Jun 2017
- Study completion10 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary DiseaseStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de La Serena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARCELO BELTRAN, Hospital de La Serena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025645
- Sponsor's protocol ID
- HLS-MBS-001
- Status last verified
- Jul 2019
- First submitted
- 17 Jul 2019
- Last updated
- 22 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Common Bile Duct Pressures in Patients With and Without Cholelithiasis: A Cases and Controls Study
- ClinicalTrials.gov ID
- NCT04025645
- Acronym / sponsor ID
- HLS-MBS-001
- Conditions
- Biliary Disease
- Keywords
- Cholelithiasis, Common Bile Duct, Sphincter of Oddi, Amylase, Lipase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Hospital de La SerenaUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 10 Jul 2019 (actual)
- First posted
- 19 Jul 2019 (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.
Objective. To measure the pressures of the common bile duct in patients with and without cholelithiasis and relating them to the presence of pancreatobiliary reflux.
Summary Background Data. The reflux of pancreatic enzymes into the epithelium of the bile duct and mainly of the gallbladder is an abnormal phenomenon that plays a role in the lithogenesis and carcinogenesis of this epithelium. It has been suggested that the cause of this reflux is the dysfunction of the sphincter of Oddi. Because the pressure of the common bile duct depends on the pressures of the sphincter of Oddi, this dysfunction would be reflected in an increase in the pressure of the common bile duct in patients with cholelithiasis.
Methods. A prospective case-control study was designed. The universe was constituted by a convenience sample in which all patients undergoing gastrectomy for gastric cancer during 30 months in our institution were included. The primary outcome measure was to establish differences between common bile duct pressures in patients with and without cholelithiasis.
Results. Common bile duct pressures in patients with gallstones showed a significant elevation (Mean 16.9 mmHg) compared to those of patients without gallstones (Mean 3.3 mm Hg) (p<0.0001). These pressures correlated with the values of amylase and lipase in gallbladder bile; higher levels of these enzymes were found in patients with gallstones compared to patients without gallstones (p<0.0001).
Conclusions. Common bile duct pressures in patients with cholelithiasis were significantly elevated above the parameters previously considered normal.
Detailed description
A prospective study of cases and controls was designed using a previously validated model for the study of occult pancreatobiliary reflux in patients undergoing gastrectomy for gastric cancer, in which cholecystectomy is routine according to the oncological surgery protocol for gastric cancer of our institution. The study universe was constituted by a convenience sample in which all patients undergoing gastrectomy for gastric cancer during the period between January 2015 and June 2017 the investigators included. All patients included in this study signed a detailed informed consent regarding the interventions to be performed and the objectives of the study.
Cholecystectomy was performed in all patients after the section of the duodenum. Before the manipulation and dissection of the Calot triangle, a sample of 5 to 10 cc of bile was taken directly from the gallbladder. The sample was stored in a sterile tube at room temperature and immediately sent for processing. The technicians of our institutional laboratory that processed the sample did not know the details of the study. The cholecystectomy was then carried out until the cystic was reached and was cut as proximally as possible to the gallbladder. Through the cystic duct, a 4 French feeding tube equivalent to 1.35 mm in diameter (Well Lead®, Hamburg, Germany) was introduced until reaching a distance of 3 cm distal to the junction of the cystic duct and the common bile duct. Once tested for patency, this probe was connected to a standard pressure transducer used to measure intra-arterial pressure (Edwards Lifesciences™, Irvine, California, USA) and this was connected to a B40 monitor (General Electric® Medical Systems, Milwaukee, WI, USA) with the ability, among other functions, to perform pressure measurements in millimeters of mercury. The level of the junction of the cystic duct and the common bile duct was taken as a zero point, as previously described. Once the whole system was irrigated with 0.9% physiological solution and the zero point was established on the monitor with the system closed, the system was opened and pressures were measured. The minimum, maximum and mean pressures were recorded for one minute. After the procedure was completed, the gastrectomy was performed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PATIENTS WITH CHOLELITHIASIS | – | Diagnostic Test: MEASUREMENT OF COMMON BILE DUCT PRESSURESCOMMON BILE DUCT PRESSURES WERE MEASURED IN PATIENTS WITH CHOLELITHIASIS |
| PATIENTS WITHOUT CHOLELITHIASIS | – | Diagnostic Test: MEASUREMENT OF COMMON BILE DUCT PRESSURESCOMMON BILE DUCT PRESSURES WERE MEASURED IN PATIENTS WITHOUT CHOLELITHIASIS |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with gastric cancer undergoing elective surgery
Key inclusion criteria (1 listed)
- All patients with normal values of amylase, lipase, and liver function tests measured 24 hours before the intervention
Key exclusion criteria (2 listed)
- Patients previously cholecystectomized
- Patients with clinical, radiological and laboratory evidence of common bile duct stones
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 |
|---|---|---|
| MEASUREMENT OF COMMON BILE DUCT PRESSURESTHE PRESSURES OF THE COMMON BILE DUCT WERE MEASURED | Diagnostic test | PATIENTS WITH CHOLELITHIASIS, PATIENTS WITHOUT CHOLELITHIASIS |
Primary outcome
Common bile duct pressures
Time frame: Two and a half years
Establish differences between common bile duct pressures in patients with and without gallstones
1 secondary outcome
Levels of amylase and lipase in bile
Time frame: Two and a half years
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 22 Jul 2019.
- Individual participant dataSharing planned: No
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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 Biliary Disease, run by Hospital de La Serena.
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 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: finished, as of the sponsor's last update on 22 Jul 2019. 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?
Common bile duct pressures (time frame: Two and a half years). 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 22 Jul 2019.