Common Bile Duct StonesNCT02497872
Early Precut Versus Pancreatic Stent for Post-ERCP Pancreatitis
A study testing Biliary stone removal in people with Common Bile Duct Stones, run by Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno.
Trial summary
BACKGROUND: The most common complication of endoscopic retrograde cholangiopancreatography (ERCP) is pancreatitis. Precut sphincterotomy has been regarded as a risk factor. However, early precut may actually reduce post-ERCP pancreatitis risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Common Bile Duct Stones
- What is being tested?
- Biliary stone removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Dec 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with in need for ERCP due to benign or malignant biliopancreatic conditions, with at least one of the following features:
- female sex
- age less than 40 years
- clinical suspicion of Sphincter of Oddi Dysfunction
- previous pancreatitis
- common bile duct diameter of less than 8 mm
- Subjects with difficult biliary cannulation, as defined by previously published criteria
Who cannot join
- patients with contrast allergy
- pregnant women
- patients unable to sign informed consent
About this study
Official title: Early Precut Versus Pancreatic Duct Stent in Preventing Post-ERCP Pancreatitis in High-risk Subjects
BACKGROUND: The most common complication of endoscopic retrograde cholangiopancreatography (ERCP) is pancreatitis. Precut sphincterotomy has been regarded as a risk factor. However, early precut may actually reduce post-ERCP pancreatitis risk. However, early precut as a preventive measure has not been compared to other preventive measures, such as pancreatic duct stent placement.
AIM: To compare the efficacy of early precut sphincterotomy versus pancreatic duct stent placement in high-risk subjects undergoing ERCP.
MATERIALS AND METHODS: This is a single-blinded, randomized trial that took place in two tertiary referral centers in Buenos Aires. ERCP subjects shall present at least one of the following risk factors: female sex, age less than 40 years, clinical suspicion of Sphincter of Oddi dysfunction, previous pancreatitis, common bile duct diameter of less than 8 mm. Only those who present a difficult biliary cannulation shall be randomized into two groups: those who receive early precut sphincterotomy or those in whom persistency of biliary cannulation is intended with subsequent pancreatic duct stent placement after cholangiography is achieved. The incidence of post-ERCP pancreatitis as well as other complications shall be compared.
Read the detailed description
It is well known that pancreatitis is the most common and dreadful complication of endoscopic retrograde cholangiopancreatography (ERCP). Historically, precut sphincterotomy has been regarded as a risk factor for post-ERCP pancreatitis. However, some evidence has suggested that if used at an early point during the procedure, it may actually behave as a protective factor.
In high risk patients, such as those patients with sphincter of Oddi dysfunction, pancreatic duct stent placement has been considered to be a prophylactic measure against pancreatitis. However, pancreatic duct stent placement can sometimes be a cumbersome procedure, and may require additional procedures (mainly if spontaneous stent dislodgment is not accomplished). There is no evidence comparing early precut versus pancreatic duct stent placement in high-risk patients.
As a consequence, the aim of this study was to compare the efficacy of early precut sphincterotomy versus pancreatic duct stent placement in patients presenting at least one risk factor for post-ERCP pancreatitis and difficult biliary cannulation.
A single-blinded, randomized trial was undertaken. Patients fulfilling inclusion criteria who presented with difficult biliary cannulation during ERCP were randomized to early precut or persistence in biliary cannulation with a sphincterotome with posterior pancreatic duct stent placement. The incidence of post-ERCP pancreatitis as well as other complications were compared between groups.
- Conditions
- Common Bile Duct Stones
- Being tested
- Biliary stone removal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biliary stone removalProcedure or surgery
Biliary stones are removed from the common bile duct by means of a sphincterotomy performed by standardized endoscopic retrograde cholangiopancreatography
| Study group | Role | What they receive |
|---|---|---|
| Early Precut Sphincterectomy | Experimental | Biliary stone removal using early precut: Patients enrolled in this arm received biliary drainage through a small incision on the papilla with an endoscopic needle-knife - a technique called precut sphincterotomy. Receives: Procedure: Biliary stone removal |
| Pancreatic Duct Stent | Active comparator | Biliary stone removal using persistence of cannulation and a later pancreatic duct stent placement: Patients enrolled in this arm received conventional biliary drainage through persistent biliary cannulation. After completion of biliary drainage, a prophylactic pancreatic duct stent was placed. Receives: Procedure: Biliary stone removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-ERCP Pancreatitis
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startNov 2011
- Primary completionDec 2013
- Study completionDec 2013
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Lasa, Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02497872
- Sponsor's protocol ID
- ERCP001
- Status last verified
- Jul 2015
- First submitted
- 29 May 2015
- Last updated
- 15 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Precut Versus Pancreatic Duct Stent in Preventing Post-ERCP Pancreatitis in High-risk Subjects
- ClinicalTrials.gov ID
- NCT02497872
- Acronym / sponsor ID
- ERCP001
- Conditions
- Common Bile Duct Stones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centro de Educación Medica e Investigaciones Clínicas Norberto QuirnoUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 15 Jul 2015 (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.
BACKGROUND: The most common complication of endoscopic retrograde cholangiopancreatography (ERCP) is pancreatitis. Precut sphincterotomy has been regarded as a risk factor. However, early precut may actually reduce post-ERCP pancreatitis risk. However, early precut as a preventive measure has not been compared to other preventive measures, such as pancreatic duct stent placement.
AIM: To compare the efficacy of early precut sphincterotomy versus pancreatic duct stent placement in high-risk subjects undergoing ERCP.
MATERIALS AND METHODS: This is a single-blinded, randomized trial that took place in two tertiary referral centers in Buenos Aires. ERCP subjects shall present at least one of the following risk factors: female sex, age less than 40 years, clinical suspicion of Sphincter of Oddi dysfunction, previous pancreatitis, common bile duct diameter of less than 8 mm. Only those who present a difficult biliary cannulation shall be randomized into two groups: those who receive early precut sphincterotomy or those in whom persistency of biliary cannulation is intended with subsequent pancreatic duct stent placement after cholangiography is achieved. The incidence of post-ERCP pancreatitis as well as other complications shall be compared.
Detailed description
It is well known that pancreatitis is the most common and dreadful complication of endoscopic retrograde cholangiopancreatography (ERCP). Historically, precut sphincterotomy has been regarded as a risk factor for post-ERCP pancreatitis. However, some evidence has suggested that if used at an early point during the procedure, it may actually behave as a protective factor.
In high risk patients, such as those patients with sphincter of Oddi dysfunction, pancreatic duct stent placement has been considered to be a prophylactic measure against pancreatitis. However, pancreatic duct stent placement can sometimes be a cumbersome procedure, and may require additional procedures (mainly if spontaneous stent dislodgment is not accomplished). There is no evidence comparing early precut versus pancreatic duct stent placement in high-risk patients.
As a consequence, the aim of this study was to compare the efficacy of early precut sphincterotomy versus pancreatic duct stent placement in patients presenting at least one risk factor for post-ERCP pancreatitis and difficult biliary cannulation.
A single-blinded, randomized trial was undertaken. Patients fulfilling inclusion criteria who presented with difficult biliary cannulation during ERCP were randomized to early precut or persistence in biliary cannulation with a sphincterotome with posterior pancreatic duct stent placement. The incidence of post-ERCP pancreatitis as well as other complications were compared between groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Precut Sphincterectomy | Experimental | Procedure: Biliary stone removalBiliary stone removal using early precut: Patients enrolled in this arm received biliary drainage through a small incision on the papilla with an endoscopic needle-knife - a technique called precut sphincterotomy. |
| Pancreatic Duct Stent | Active comparator | Procedure: Biliary stone removalBiliary stone removal using persistence of cannulation and a later pancreatic duct stent placement: Patients enrolled in this arm received conventional biliary drainage through persistent biliary cannulation. After completion of biliary drainage, a prophylactic pancreatic duct stent was placed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects with in need for ERCP due to benign or malignant biliopancreatic conditions, with at least one of the following features:
- female sex
- age less than 40 years
- clinical suspicion of Sphincter of Oddi Dysfunction
- previous pancreatitis
Key exclusion criteria (3 listed)
- patients with contrast allergy
- pregnant women
- patients unable to sign informed consent
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 |
|---|---|---|
| Biliary stone removalBiliary stones are removed from the common bile duct by means of a sphincterotomy performed by standardized endoscopic retrograde cholangiopancreatography | Procedure or surgery | Early Precut Sphincterectomy, Pancreatic Duct Stent |
Primary outcome
Post-ERCP Pancreatitis
Time frame: 48 hours
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 15 Jul 2015.
Related trials for Common Bile Duct Stones
Recruiting
ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly
Cholecystectomy, Laparoscopic, Choledocholithiasis
Recruiting
Hyoscine Butylbromide During Transcystic Papillary Balloon Dilation for Choledocholithiasis
Choledocholithiasis, Common Bile Duct Stones
RecruitingObservational study
Influence of Gut Microbiome in Gallstone Disease
Gall Stone, Gall Stones, Common Bile Duct
Recruiting
ChOlanGiography Performed Routinely Versus Selectively During Cholecystectomy: A NAtional Registry-based Randomized Controlled Trial
Cholecystolithiasis, Common Bile Duct Gall Stones
Not yet recruiting
EUS-Guided Gallbladder Drainage Versus Conservative Management in Patients Unfit for Surgery After a Biliary Event Without Cholecystitis. DRECON Study
Cholecystectomy, Gallbladder
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?
A study testing Biliary stone removal in people with Common Bile Duct Stones, run by Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno.
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 7 inclusion and 3 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 15 Jul 2015. 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-ERCP Pancreatitis (time frame: 48 hours). 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 15 Jul 2015.