Pancreaticobiliary RefluxNCT00890201
Pancreaticobiliary Reflux in Patients Without Cholelithiasis
An observational study of Pancreaticobiliary Reflux, run by Cirujanos la Serena at 1 site in Chile.
Trial summary
Pancreaticobiliary reflux has been found in patients with cholelithiasis and gallbladder cancer associated with normal pancreaticobiliary union. However, the presence of pancreaticobiliary reflux has not been studied in patients without gallstones (healthy gallbladders). Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Pancreaticobiliary Reflux
- What is being tested?
- Gallbladder bile sampling and intraoperative cholangiography
- Type of treatment
- Surgery or procedure
- How many people
- 197 participants
- Where
- 1 siteChile
- Study dates
- Jan 2009to Jul 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 1. Patients with gallstones (symptomatic cholelithiasis) submitted to elective surgery. 2. Patients without gallstones submitted to elective surgery for benign or malignant gastroesophageal diseases
Who may be able to join
- Age older than 15 years of age
- Elective surgery
- Normal intraoperative cholangiography
- Normal preoperative serum amylase and lipase values
Who cannot join
- Common bile duct stones
- Anatomic anomalies at the pancreaticobiliary junction evidenced by intraoperative cholangiography
- Altered preoperative amylase and lipase levels
- Altered preoperative hepatic function tests
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Pancreaticobiliary Reflux in Patients With Cholelithiasis and Without Cholelithiasis a Normal Phenomenon?
Pancreaticobiliary reflux has been found in patients with cholelithiasis and gallbladder cancer associated with normal pancreaticobiliary union. However, the presence of pancreaticobiliary reflux has not been studied in patients without gallstones (healthy gallbladders).
The authors believe that pancreaticobiliary reflux might be a normal phenomenon in patients with and without gallstones, although in patients with cholelithiasis it might constitute a pathological condition associated with dismotility of the biliary tree and the sphincter of Oddi.
Read the detailed description
The objective of this study is to measure the levels of amylase and lipase in gallbladder bile of patients without gallstones and compare these values to the values of amylase and lipase of patients with gallstones and normal pancreaticobiliary union evidenced by intraoperative cholangiography.
- Conditions
- Pancreaticobiliary Reflux
- Being tested
- Gallbladder bile sampling and intraoperative cholangiography
- Keywords
- Pancreaticobiliary reflux, Normal pancreaticobiliary junction, Gallstones, Cholelithiasis, Cholecystectomy
- Medical subject headings
- Gallstones, Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gallbladder bile sampling and intraoperative cholangiographyProcedure or surgery
Also called Measurement of pancreaticobiliary reflux
Interventions were exactly similar for both groups, and that is how it was intended to be:
Gallbladder bile sampling: Sample 5 cc of gallbladder bile after the cystic duct has been clipped or ligated.
Intraoperative cholangiography: Perform cholangiography before the cholecystectomy is finished
| Study group | Role | What they receive |
|---|---|---|
| Normal Gallbladder | Patients with normal gallbladder (without gallstones) evidenced by preoperative ultrasonography (and postoperative biopsy) submitted to elective gastroesophageal surgery (gastrectomy for gastric cancer, bariatric surgery or esophageal surgery such as Nissen plicature or miotomy for achalasia).
The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography. Preoperative values of amylase and lipase must be normal. Receives: Procedure: Gallbladder bile sampling and intraoperative cholangiography | |
| Gallbladder with gallstones | Patients submitted to elective cholecystectomy for diseased gallbladders (gallbladder with gallstones evidenced by preoperative ultrasound).
The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography and the preoperative amylase and lipase levels must also be normal. Receives: Procedure: Gallbladder bile sampling and intraoperative cholangiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amylase and Lipase Values in Gallbladder Bile
Normal values of lipase and amylase in gallbladder bile should be zero
Measured: 24 hours
Secondary outcomes (4)
Amylase and Lipase Values in Normal Gallbladders
Measured: 24 hours
Amylase and Lipase Values in Gallbladders With Cholelithiasis
Measured: 24 hours
Normal Operative Cholangiography
Measured: 24 hours
Normal Preoperative Serum Values of Amylase and Lipase
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startJan 2009
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreaticobiliary RefluxStudies 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
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cirujanos la Serena
- Sponsor type
- University, hospital or other
- Investigators
- MARCELO A BELTRAN, M.D., Principal investigator, Hospital de La Serena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00890201
- Sponsor's protocol ID
- HLS-2704009-02
- Status last verified
- Sep 2010
- First submitted
- 28 Apr 2009
- Last updated
- 17 Dec 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Beltran MA, Vracko J, Cumsille MA, Cruces KS, Almonacid J, Danilova T. Occult pancreaticobiliary reflux in gallbladder cancer and benign gallbladder diseases. J Surg Oncol. 2007 Jul 1;96(1):26-31. doi: 10.1002/jso.20756.
PubMed 17345616Beltran MA, Contreras MA, Cruces KS. Pancreaticobiliary reflux in patients with and without cholelithiasis: is it a normal phenomenon? World J Surg. 2010 Dec;34(12):2915-21. doi: 10.1007/s00268-010-0771-2.
PubMed 20811747
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Pancreaticobiliary Reflux in Patients With Cholelithiasis and Without Cholelithiasis a Normal Phenomenon?
- ClinicalTrials.gov ID
- NCT00890201
- Acronym / sponsor ID
- HLS-2704009-02
- Conditions
- Pancreaticobiliary Reflux
- Keywords
- Pancreaticobiliary reflux, Normal pancreaticobiliary junction, Gallstones, Cholelithiasis, Cholecystectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Cirujanos la SerenaUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 29 Apr 2009 (estimated)
- Results
- Posted 20 Oct 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pancreaticobiliary reflux has been found in patients with cholelithiasis and gallbladder cancer associated with normal pancreaticobiliary union. However, the presence of pancreaticobiliary reflux has not been studied in patients without gallstones (healthy gallbladders).
The authors believe that pancreaticobiliary reflux might be a normal phenomenon in patients with and without gallstones, although in patients with cholelithiasis it might constitute a pathological condition associated with dismotility of the biliary tree and the sphincter of Oddi.
Detailed description
The objective of this study is to measure the levels of amylase and lipase in gallbladder bile of patients without gallstones and compare these values to the values of amylase and lipase of patients with gallstones and normal pancreaticobiliary union evidenced by intraoperative cholangiography.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Gallbladder | – | Procedure: Gallbladder bile sampling and intraoperative cholangiographyPatients with normal gallbladder (without gallstones) evidenced by preoperative ultrasonography (and postoperative biopsy) submitted to elective gastroesophageal surgery (gastrectomy for gastric cancer, bariatric surgery or esophageal surgery such as Nissen plicature or miotomy for achalasia). The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography. Preoperative values of amylase and lipase must be normal. |
| Gallbladder with gallstones | – | Procedure: Gallbladder bile sampling and intraoperative cholangiographyPatients submitted to elective cholecystectomy for diseased gallbladders (gallbladder with gallstones evidenced by preoperative ultrasound). The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography and the preoperative amylase and lipase levels must also be normal. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1. Patients with gallstones (symptomatic cholelithiasis) submitted to elective surgery. 2. Patients without gallstones submitted to elective surgery for benign or malignant gastroesophageal diseases
Key inclusion criteria (4 listed)
- Age older than 15 years of age
- Elective surgery
- Normal intraoperative cholangiography
- Normal preoperative serum amylase and lipase values
Key exclusion criteria (5 listed)
- Common bile duct stones
- Anatomic anomalies at the pancreaticobiliary junction evidenced by intraoperative cholangiography
- Altered preoperative amylase and lipase levels
- Altered preoperative hepatic function tests
- Emergency surgery
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 |
|---|---|---|
| Gallbladder bile sampling and intraoperative cholangiographyAlso: Measurement of pancreaticobiliary refluxInterventions were exactly similar for both groups, and that is how it was intended to be: Gallbladder bile sampling: Sample 5 cc of gallbladder bile after the cystic duct has been clipped or ligated. Intraoperative cholangiography: Perform cholangiography before the cholecystectomy is finished | Procedure or surgery | Gallbladder with gallstones, Normal Gallbladder |
Primary outcome
Amylase and Lipase Values in Gallbladder Bile
Time frame: 24 hours
Normal values of lipase and amylase in gallbladder bile should be zero
4 secondary outcomes
Amylase and Lipase Values in Normal Gallbladders
Time frame: 24 hours
Amylase and Lipase Values in Gallbladders With Cholelithiasis
Time frame: 24 hours
Normal Operative Cholangiography
Time frame: 24 hours
Normal Preoperative Serum Values of Amylase and Lipase
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17345616Beltran MA, Vracko J, Cumsille MA, Cruces KS, Almonacid J, Danilova T. Occult pancreaticobiliary reflux in gallbladder cancer and benign gallbladder diseases. J Surg Oncol. 2007 Jul 1;96(1):26-31. doi: 10.1002/jso.20756.
- Derived from this study: PubMed 20811747Beltran MA, Contreras MA, Cruces KS. Pancreaticobiliary reflux in patients with and without cholelithiasis: is it a normal phenomenon? World J Surg. 2010 Dec;34(12):2915-21. doi: 10.1007/s00268-010-0771-2.
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.
MARCELO A BELTRAN, M.D. principal investigator
Hospital de La Serena
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 Pancreaticobiliary Reflux, run by Cirujanos la Serena at 1 site in Chile.
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 4 inclusion and 5 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 17 Dec 2010. 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 Chile. 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?
Yes. Results are posted in the registry (first posted 20 Oct 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Amylase and Lipase Values in Gallbladder Bile (time frame: 24 hours). 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 NCT00890201, which also lists 2 linked publications.
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 17 Dec 2010.