PancreatitisNCT02346448
Endoscopic Sphincterotomy vs. Balloon Dilation for Assessment of Pancreatitis
A study testing endoscopic sphincterotomy, balloon dilatation for 3 minutes and balloon dilatation for 6 minutes in people with Pancreatitis, run by Helios Albert-Schweitzer-Klinik Northeim at 3 sites in Germany.
Trial summary
One of the major elements of successful endoscopic retrograde cholangiopancreatography ( ERCP) is the timely and uncomplicated cannulation of the common bile duct (CBD) . Various factors may adversely affect the cannulation procedure of the CBD leading to complications (acute pancreatitis after ERCP, perforation of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis
- What is being tested?
- endoscopic sphincterotomy, balloon dilatation for 3 minutes and balloon dilatation for 6 minutes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 3 sitesGermany
- Study dates
- Feb 2015to Dec 2020
- 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
- independent indication for ERCP
- age ≥ 18 years
- patient is able to understand informed consent
Who cannot join
- S/p sphincterotomy
- pancreatic or CBD-stent in situ
- pregnant patient
- known chronic pancreatitis
- acute pancreatitis prior to intervention
Trial locations and contacts
3 sites in 1 country.
Germany3 sites, 3 recruiting
- Recruiting
HELIOS Klinikum Erfurt
Erfurt, Thuringia, 99089
Jens Scharf, Professor
+49361 7810, jens-gerd.scharf@helios-kliniken.de
- Recruiting
Department of Gastroenterology, University Medical Center
Göttingen, Lower Saxony, 37075
Volker Ellenrieder, Professor, +49551390, Volker.Ellenrieder@med.uni-goettingen.de
- Recruiting
HELIOS Albert-Schweitzer Hospital Northeim
Northeim, Lower Saxony, 37154
Tobias Meister, PDDr.med., +495551971244, tobias.meister@helios-kliniken.de
About this study
Official title: Endoscopic Sphincterotomy vs. Balloon Dilation for Assessment of Pancreatitis: A Prospective Randomized Multicenter Trial
One of the major elements of successful endoscopic retrograde cholangiopancreatography ( ERCP) is the timely and uncomplicated cannulation of the common bile duct (CBD) . Various factors may adversely affect the cannulation procedure of the CBD leading to complications (acute pancreatitis after ERCP, perforation of the duodenum , bleeding ). Endoscopic sphincterotomy is frequently required for interventional procedures (eg stone extraction). During sphincterotomy, incision of the orifice of the papilla will be performed by using a sphincterotome. Complications due to sphincterotomy are known: Bleeding, increased rates of acute pancreatitis, small bowel perforation and scarring with consecutive stenosis of the papilla. As an alternative to sphincterotomy, balloon dilatation using balloon catheters can be performed. As a result, bleeding complications and scarring as late effects might be prevented. Current data is limited in terms of the risk of acute pancreatitis after ERCP when using a balloon catheter.
This study aims to evaluate the incidence of acute pancreatitis and other complications after ERCP. Balloon dilatation of the papilla will be prospectively compared with endoscopic sphincterotomy in a randomized multicenter setting.
- Conditions
- Pancreatitis
- Being tested
- endoscopic sphincterotomy, balloon dilatation for 3 minutes, balloon dilatation for 6 minutes
- Keywords
- endoscopic sphincterotomy, balloon dilation, adverse events, pancreatitis, bleeding
- Medical subject headings
- Pancreatitis, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic sphincterotomyProcedure or surgery
sphincterotomy during ERCP
balloon dilatation for 3 minutesProcedure or surgery
balloon dilatation during ERCP using 10mm balloon
balloon dilatation for 6 minutesProcedure or surgery
balloon dilatation during ERCP using 10mm balloon
| Study group | Role | What they receive |
|---|---|---|
| endoscopic sphincterotomy | Active comparator | performing endoscopic sphincterotomy of papilla of Vater during ERCP Device: standard sphincterotome Receives: Procedure: endoscopic sphincterotomy |
| balloon dilatation for 3 minutes | Active comparator | Balloon dilatation of papilla of Vater for 3 minutes during ERCP using 10mm balloon Device: standard dilation balloon catheter (10mm size) Receives: Procedure: balloon dilatation for 3 minutes |
| balloon dilatation for 6 minutes | Active comparator | Balloon dilatation of papilla of Vater for 6 minutes during ERCP using 10mm balloon Device: standard dilation balloon catheter (10 mm size) Receives: Procedure: balloon dilatation for 6 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute pancreatitis
Definition of acute pancreatitis: Serum lipase or amylase obtained 2 to 6 hours following ERCP + onset of abdominal pain after ERCP persisting for 24h+ need for analgesia
Measured: one to 10 days
Secondary outcomes (3)
severity of pancreatitis using the Imrie score system (according to Imrie et al.)
assessment of severity by Imrie score: mild pancreatitis defined by Imrie score <3, severe pancreatitis if Imrie score >=3
Measured: one to 10 days
endoscopic perforation
signs of perforation after ERCP, proven by CT scan or surgery
Measured: one to two days
major bleeding
any bleeding events associated with ERCP. Drop of Hemoglobin of > 2g/dl and signs of bleeding
Measured: one to two days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helios Albert-Schweitzer-Klinik Northeim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tobias Meister, PDDr.med., Study director, Helios Albert-Schweitzer-HospitalVolker Ellenrieder, ProfDr.med., Study director, University Medical Center Göttingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02346448
- Sponsor's protocol ID
- HELIOS 4/8/14
- Status last verified
- Feb 2019
- First submitted
- 20 Jan 2015
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Sphincterotomy vs. Balloon Dilation for Assessment of Pancreatitis: A Prospective Randomized Multicenter Trial
- ClinicalTrials.gov ID
- NCT02346448
- Acronym / sponsor ID
- HELIOS 4/8/14
- Conditions
- Pancreatitis
- Keywords
- endoscopic sphincterotomy, balloon dilation, adverse events, pancreatitis, bleeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Helios Albert-Schweitzer-Klinik NortheimUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 27 Jan 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.
One of the major elements of successful endoscopic retrograde cholangiopancreatography ( ERCP) is the timely and uncomplicated cannulation of the common bile duct (CBD) . Various factors may adversely affect the cannulation procedure of the CBD leading to complications (acute pancreatitis after ERCP, perforation of the duodenum , bleeding ). Endoscopic sphincterotomy is frequently required for interventional procedures (eg stone extraction). During sphincterotomy, incision of the orifice of the papilla will be performed by using a sphincterotome. Complications due to sphincterotomy are known: Bleeding, increased rates of acute pancreatitis, small bowel perforation and scarring with consecutive stenosis of the papilla. As an alternative to sphincterotomy, balloon dilatation using balloon catheters can be performed. As a result, bleeding complications and scarring as late effects might be prevented. Current data is limited in terms of the risk of acute pancreatitis after ERCP when using a balloon catheter.
This study aims to evaluate the incidence of acute pancreatitis and other complications after ERCP. Balloon dilatation of the papilla will be prospectively compared with endoscopic sphincterotomy in a randomized multicenter setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| endoscopic sphincterotomy | Active comparator | Procedure: endoscopic sphincterotomyperforming endoscopic sphincterotomy of papilla of Vater during ERCP Device: standard sphincterotome |
| balloon dilatation for 3 minutes | Active comparator | Procedure: balloon dilatation for 3 minutesBalloon dilatation of papilla of Vater for 3 minutes during ERCP using 10mm balloon Device: standard dilation balloon catheter (10mm size) |
| balloon dilatation for 6 minutes | Active comparator | Procedure: balloon dilatation for 6 minutesBalloon dilatation of papilla of Vater for 6 minutes during ERCP using 10mm balloon Device: standard dilation balloon catheter (10 mm size) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- independent indication for ERCP
- age ≥ 18 years
- patient is able to understand informed consent
Key exclusion criteria (5 listed)
- S/p sphincterotomy
- pancreatic or CBD-stent in situ
- pregnant patient
- known chronic pancreatitis
- acute pancreatitis prior to intervention
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 |
|---|---|---|
| endoscopic sphincterotomysphincterotomy during ERCP | Procedure or surgery | endoscopic sphincterotomy |
| balloon dilatation for 3 minutesballoon dilatation during ERCP using 10mm balloon | Procedure or surgery | balloon dilatation for 3 minutes |
| balloon dilatation for 6 minutesballoon dilatation during ERCP using 10mm balloon | Procedure or surgery | balloon dilatation for 6 minutes |
Primary outcome
acute pancreatitis
Time frame: one to 10 days
Definition of acute pancreatitis: Serum lipase or amylase obtained 2 to 6 hours following ERCP + onset of abdominal pain after ERCP persisting for 24h+ need for analgesia
3 secondary outcomes
severity of pancreatitis using the Imrie score system (according to Imrie et al.)
Time frame: one to 10 days
endoscopic perforation
Time frame: one to two days
major bleeding
Time frame: one to two days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
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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.
Tobias Meister, PDDr.med. study director
Helios Albert-Schweitzer-Hospital
Volker Ellenrieder, ProfDr.med. study director
University Medical Center Göttingen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopic sphincterotomy, balloon dilatation for 3 minutes and balloon dilatation for 6 minutes in people with Pancreatitis, run by Helios Albert-Schweitzer-Klinik Northeim at 3 sites in Germany.
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 3 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: status not confirmed, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tobias Meister, PDDr.med. (+495551971244, tobias.meister@helios-kliniken.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acute pancreatitis (time frame: one to 10 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 12 Feb 2019.