Bile Duct DiseasesNCT01493076
Safety and Efficacy of a Newly Developed Baby-sphincterotome for Bile Duct Cannulation
An observational study of Bile Duct Diseases, run by Ruhr University of Bochum.
Trial summary
Precut-sphincterotomy is a well established alternative after repeated futile attempts for common bile duct (CBD) cannulation with standard catheters and/or guide-wires fail. Commonly used devices instruments for pre-cutting are the needle-knife and the Erlangen-type precut-sphincterotome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bile Duct Diseases
- What is being tested?
- Primary cannulation/precut sphincterotomie with the Baby-S
- Type of treatment
- Medical device
- How many people
- 1,886 participants
- Where
- No sites listed yet
- Study dates
- Jun 2000to Nov 2011
- 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: Use of the baby-sphincterotome for cannulation and pre-cut in cases of failed selective wire-guided bile duct access.
Who may be able to join
- Evidence for bile duct obstruction with a visible stone or tumor, dilated common bile duct > 7 mm (or > 9 mm in cholecystectomised patients) by ultrasonography and CT-scan or MRCP/EUS, an elevated serum bilirubin level > 1.4 mg/dl, and serum alkaline phosphatase > 200 U/l with clinical suspicion of obstruction without evidence for cholestatic liver disease.
Who cannot join
- Patients with severe coagulation disorders or distorted anatomy of the major papilla (malignant infiltration of the papilla, papillary porus not identifiable, impacted stone) and patients with former gastro-duodenal resection (e.g. BII-anatomy) were excluded
About this study
Official title: Safety and Efficacy of a New Baby-sphincterotome for Cannulation and Pre-cut in Failed Selective Wire-guided Bile Duct Access
Precut-sphincterotomy is a well established alternative after repeated futile attempts for common bile duct (CBD) cannulation with standard catheters and/or guide-wires fail. Commonly used devices instruments for pre-cutting are the needle-knife and the Erlangen-type precut-sphincterotome. In 1996 a so called "baby-sphincterotome" (Easy-Cut®, MTW, Wesel, Germany) with a pre-shaped-bended (to facilitate biliary access) small-calibre 3-French tip was developed, which enables cannulation and pre-cutting in one step. Here the investigators report on the clinical evaluation of this device.
Read the detailed description
Interventional procedures at the bile or pancreatic duct require selective cannulation of the desired duct and sometimes endoscopic sphincterotomy (ES). If it is not possible to achieve selective access to the desired duct, which occurs in about 10-33 % of the cases (1-4), the next step to ensure selective cannulation is a so-called pre-cut procedure (5-8). For this approach a needle knife or an Erlangen-type sphincterotome are used to perform pre-cut sphincterotomy (PCS). This pre-cut technique has been shown to be effective especially to obtain selective bile duct access in the majority of the cases whenever standard cannulation techniques fail. However, the reported complication rate for PCS is substantially higher than for conventional ES (9), but may be outweighed by the clinical benefits. A limitation of the PCS-procedure is the need to use a dedicated instrument (either the needle knife or the Erlangen-type sphincterotome) for this indication. After completion of the pre-cut procedure routinely the attempt access to the desired duct has to be performed with other accessories since most pre-cut-sphincterotomes did do not allow contrast injection or guide-wire insertion. A change of instruments before and after PCS prolongs procedure time and increases cost. Therefore a "universal" instrument designed for both bile duct cannulation and precutting would substantially simplify the procedure.
In 1999 the investigators described a newly developed "baby"-sphincterotome that combines the features of a cannulating catheter and Erlangen-type precut-papillotome. In a first series of patients this device was found to be useful for direct cannulation as well as for precut procedures (10).
The aim of this trial was to investigate the safety and efficacy of this newly developed baby-sphincterotome in cases of failed selective wire-guided bile duct cannulation in a large cohort of patients.
Inclusion criteria were: evidence for bile duct obstruction with a visible stone or tumor, dilated common bile duct > 7 mm (or > 9 mm in cholecystectomised patients) by ultrasonography and CT-scan or MRCP/EUS, an elevated serum bilirubin level > 1.4 mg/dl, and serum alkaline phosphatase > 200 U/l with clinical suspicion of obstruction without evidence for cholestatic liver disease.
Patients with severe coagulation disorders or distorted anatomy of the major papilla (malignant infiltration of the papilla, papillary porus not identifiable, impacted stone) and patients with former gastro-duodenal resection (e.g. BII-anatomy) were excluded.
- Conditions
- Bile Duct Diseases
- Being tested
- Primary cannulation/precut sphincterotomie with the Baby-S
- Keywords
- ERCP, Cannulation, Precut, Mini-spincterotome
- Medical subject headings
- Bile Duct Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary cannulation/precut sphincterotomie with the Baby-SDevice
Also called Easy-Cut®, MTW, Wesel, Germany
At the papilla the ankle for cannulation was optimized due to changes of the position of the sphincterotome, its lay in the working channel and the tension of the "Albaran"-lever and the cutting wire. After successful cannulation, the catheter with the sphincterotome inside was slightly pushed into the duct. If necessary, the baby-sphincterotome was replaced with a guide wire and than conventional endoscopic sphincterotomie was completed with a standard traction-type sphincterotome.
| Study group | Role | What they receive |
|---|---|---|
| Baby-S group | The baby-sphincterotome was in patients in whom biliary sphincterotomy was clinically indicated but in whom after standard techniques to gain biliary access had failed (study population). Receives: Device: Primary cannulation/precut sphincterotomie with the Baby-S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with successfull bile duct cannulation
The baby-sphincterotome was used in patients in whom biliary sphincterotomy was clinically indicated but in whomafter standard techniques to gain biliary access had failed (study population).
Measured: Time-to-Event Outcome Measures from the beginning of the intervention until the end of the endoscopic procedure, participants will be followed for the duration of hospital stay, an expected average of 3-5 days
Secondary outcomes (1)
Postinterventional compilation rate (bleeding, pancreatitis)
The severity of post-ERCP-pancreatitis was graded according to the Cotton criteria (Cotton et al.). Mild post-sphincterotomy bleeding was any bleeding episode detected after ES or PCS that necessitatinge an endoscopic maneuver like injection or clipping whithin the same session.
Measured: Immediate or delayed complications. Time-to-Event Outcome Measures: from the beginning of the intervention till signs bleeding or panceatitis will occur. Participants will be followed for the duration of hospital stay, an expected average of 3-5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startJun 2000
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bile Duct DiseasesStudies 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
- Prospective
- Enrolment
- 1,886 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Riphaus, Ruhr University of Bochum
- Investigators
- Andrea Riphaus, MD, PhD, Principal investigator, Ruhr University Bochum, Department of MedicineRiphaus Andrea, MD, PhD, Principal investigator, Department of Medicine, Ruhr University Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01493076
- Sponsor's protocol ID
- Baby-S 2011
- Status last verified
- Dec 2011
- First submitted
- 20 Nov 2011
- Last updated
- 15 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Foutch PG. A prospective assessment of results for needle-knife papillotomy and standard endoscopic sphincterotomy. Gastrointest Endosc. 1995 Jan;41(1):25-32. doi: 10.1016/s0016-5107(95)70272-5.
PubMed 7698621Seifert H, Binmoeller KF, Schmitt T, Dietrich CF, Zipf A, Caspary WF, Wehrmann T. [A new papillotome for cannulation, pre-cut or conventional papillotomy]. Z Gastroenterol. 1999 Dec;37(12):1151-5. German.
PubMed 10666838
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of a New Baby-sphincterotome for Cannulation and Pre-cut in Failed Selective Wire-guided Bile Duct Access
- ClinicalTrials.gov ID
- NCT01493076
- Acronym / sponsor ID
- Baby-S 2011
- Conditions
- Bile Duct Diseases
- Keywords
- ERCP, Cannulation, Precut, Mini-spincterotome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,886 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- Jun 2000
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 15 Dec 2011 (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.
Precut-sphincterotomy is a well established alternative after repeated futile attempts for common bile duct (CBD) cannulation with standard catheters and/or guide-wires fail. Commonly used devices instruments for pre-cutting are the needle-knife and the Erlangen-type precut-sphincterotome. In 1996 a so called "baby-sphincterotome" (Easy-Cut®, MTW, Wesel, Germany) with a pre-shaped-bended (to facilitate biliary access) small-calibre 3-French tip was developed, which enables cannulation and pre-cutting in one step. Here the investigators report on the clinical evaluation of this device.
Detailed description
Interventional procedures at the bile or pancreatic duct require selective cannulation of the desired duct and sometimes endoscopic sphincterotomy (ES). If it is not possible to achieve selective access to the desired duct, which occurs in about 10-33 % of the cases (1-4), the next step to ensure selective cannulation is a so-called pre-cut procedure (5-8). For this approach a needle knife or an Erlangen-type sphincterotome are used to perform pre-cut sphincterotomy (PCS). This pre-cut technique has been shown to be effective especially to obtain selective bile duct access in the majority of the cases whenever standard cannulation techniques fail. However, the reported complication rate for PCS is substantially higher than for conventional ES (9), but may be outweighed by the clinical benefits. A limitation of the PCS-procedure is the need to use a dedicated instrument (either the needle knife or the Erlangen-type sphincterotome) for this indication. After completion of the pre-cut procedure routinely the attempt access to the desired duct has to be performed with other accessories since most pre-cut-sphincterotomes did do not allow contrast injection or guide-wire insertion. A change of instruments before and after PCS prolongs procedure time and increases cost. Therefore a "universal" instrument designed for both bile duct cannulation and precutting would substantially simplify the procedure.
In 1999 the investigators described a newly developed "baby"-sphincterotome that combines the features of a cannulating catheter and Erlangen-type precut-papillotome. In a first series of patients this device was found to be useful for direct cannulation as well as for precut procedures (10).
The aim of this trial was to investigate the safety and efficacy of this newly developed baby-sphincterotome in cases of failed selective wire-guided bile duct cannulation in a large cohort of patients.
Inclusion criteria were: evidence for bile duct obstruction with a visible stone or tumor, dilated common bile duct > 7 mm (or > 9 mm in cholecystectomised patients) by ultrasonography and CT-scan or MRCP/EUS, an elevated serum bilirubin level > 1.4 mg/dl, and serum alkaline phosphatase > 200 U/l with clinical suspicion of obstruction without evidence for cholestatic liver disease.
Patients with severe coagulation disorders or distorted anatomy of the major papilla (malignant infiltration of the papilla, papillary porus not identifiable, impacted stone) and patients with former gastro-duodenal resection (e.g. BII-anatomy) were excluded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Baby-S group | – | Device: Primary cannulation/precut sphincterotomie with the Baby-SThe baby-sphincterotome was in patients in whom biliary sphincterotomy was clinically indicated but in whom after standard techniques to gain biliary access had failed (study population). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Use of the baby-sphincterotome for cannulation and pre-cut in cases of failed selective wire-guided bile duct access.
Key inclusion criteria (1 listed)
- Evidence for bile duct obstruction with a visible stone or tumor, dilated common bile duct > 7 mm (or > 9 mm in cholecystectomised patients) by ultrasonography and CT-scan or MRCP/EUS, an elevated serum bilirubin level > 1.4 mg/dl, and serum alkaline phosphatase > 200 U/l with clinical suspicion of obstruction without evidence for cholestatic liver disease.
Key exclusion criteria (1 listed)
- Patients with severe coagulation disorders or distorted anatomy of the major papilla (malignant infiltration of the papilla, papillary porus not identifiable, impacted stone) and patients with former gastro-duodenal resection (e.g. BII-anatomy) were excluded
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 |
|---|---|---|
| Primary cannulation/precut sphincterotomie with the Baby-SAlso: Easy-Cut®, MTW, Wesel, GermanyAt the papilla the ankle for cannulation was optimized due to changes of the position of the sphincterotome, its lay in the working channel and the tension of the "Albaran"-lever and the cutting wire. After successful cannulation, the catheter with the sphincterotome inside was slightly pushed into the duct. If necessary, the baby-sphincterotome was replaced with a guide wire and than conventional endoscopic sphincterotomie was completed with a standard traction-type sphincterotome. | Device | Baby-S group |
Primary outcome
Number of Participants with successfull bile duct cannulation
Time frame: Time-to-Event Outcome Measures from the beginning of the intervention until the end of the endoscopic procedure, participants will be followed for the duration of hospital stay, an expected average of 3-5 days
The baby-sphincterotome was used in patients in whom biliary sphincterotomy was clinically indicated but in whomafter standard techniques to gain biliary access had failed (study population).
1 secondary outcome
Postinterventional compilation rate (bleeding, pancreatitis)
Time frame: Immediate or delayed complications. Time-to-Event Outcome Measures: from the beginning of the intervention till signs bleeding or panceatitis will occur. Participants will be followed for the duration of hospital stay, an expected average of 3-5 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 15 Dec 2011.
- Background: PubMed 7698621Foutch PG. A prospective assessment of results for needle-knife papillotomy and standard endoscopic sphincterotomy. Gastrointest Endosc. 1995 Jan;41(1):25-32. doi: 10.1016/s0016-5107(95)70272-5.
- Background: PubMed 10666838Seifert H, Binmoeller KF, Schmitt T, Dietrich CF, Zipf A, Caspary WF, Wehrmann T. [A new papillotome for cannulation, pre-cut or conventional papillotomy]. Z Gastroenterol. 1999 Dec;37(12):1151-5. German.
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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.
Andrea Riphaus, MD, PhD principal investigator
Ruhr University Bochum, Department of Medicine
Riphaus Andrea, MD, PhD principal investigator
Department of Medicine, Ruhr University Bochum
Questions about this trial
What is this clinical trial studying?
An observational study of Bile Duct Diseases, run by Ruhr University of Bochum.
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 1 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 Dec 2011. 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?
Number of Participants with successfull bile duct cannulation (time frame: Time-to-Event Outcome Measures from the beginning of the intervention until the end of the endoscopic procedure, participants will be followed for the duration of hospital stay, an expected average of 3-5 days). 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 NCT01493076, 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 15 Dec 2011.