Chronic Acute PancreatitisDisductNCT01276002
Evaluation of Pancreatic Duct Stenting in Patients With Pancreatic Pseudocysts.
A study testing pancreatic duct stenting in people with Chronic Acute Pancreatitis, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial summary
The disruption of the pancreatic duct seems to be a major cause pseudocyst formation and persistence in patients suffering from acute/chronic pancreatitis. No prospective randomized studies have been conducted on the influence of pancreatic duct stenting for the patients' benefits and recurrence rates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Acute Pancreatitis
- What is being tested?
- pancreatic duct stenting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Dec 2016
- 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
- pancreatic pseudocyst, at least 6 cm in diameter
- symptomatic pancreatic pseudocyst
- increasing size of pancreatic pseudocyst within 6 weeks
Who cannot join
- Pregnancy
- Age less than 18 years
- Postoperative status preventing access to papilla
- Allergy to contrast preventing from ERP
- Missing informed consent to study
- PTT above 1.5 times of normal, unless substituted
Show all 10Show fewer
- Platelet count less than 50.000/µl, unless substituted
- Pancreatic ascites or fistula
- Life expectancy less than 2 years
- Percutaneously drained cysts are not part of the study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Interdisciplinary Endoscopy, University hospital Schleswig-Holstein, Campus Kiel
Kiel, 24105
About this study
Official title: Randomized Multicenter Study on Pancreatic Duct Stenting in Disrupted or Obstructed Ducts in Context With Endoscopic Treatment of Pancreatic Pseudocysts.
The disruption of the pancreatic duct seems to be a major cause pseudocyst formation and persistence in patients suffering from acute/chronic pancreatitis. No prospective randomized studies have been conducted on the influence of pancreatic duct stenting for the patients' benefits and recurrence rates. The aim fo this study is therefore to evaluate prospectively in a randomized, controlled fashion in patients wit pancreatic pseudocysts, wether pancreatic duct stenting of a disrupted pancreatic duct is beneficial in terms of quicker clinical recovery and avoidance of recurrence of pancreatic pseudocysts.
- Conditions
- Chronic Acute Pancreatitis
- Being tested
- pancreatic duct stenting
- Keywords
- disrupted duct, pancreatic pseudocysts
- Medical subject headings
- Pancreatic Pseudocyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pancreatic duct stentingProcedure or surgery
in case of a disrupted pancreatic duct, patients will undergo pancreatic duct stenting.
| Study group | Role | What they receive |
|---|---|---|
| No stenting | No intervention | Control group, no stenting of the pancreatic duct in case of a disrupted duct |
| Pancreatic duct stenting | Active comparator | in case of a disrupted pancreatic duct, patients will undergo pancreatic duct stenting in this arm Receives: Procedure: pancreatic duct stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of pancreatic pseudocyst
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: No appropriate participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Acute 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Ellrichmann, University Hospital Schleswig-Holstein
- Investigators
- Mark Ellrichmann, MD, Principal investigator, Interdisciplinary Endoscopy, University hospital Schleswig-Holstein, Campus Kiel, GermanyAnnette Fritscher-Ravens, MD, PhD, Study director, Interdisciplinary Endoscopy, University hospital Schleswig-Holstein, Campus Kiel, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01276002
- Sponsor's protocol ID
- UKSH-122010
- Acronym
- Disduct
- Status last verified
- Jun 2022
- First submitted
- 12 Jan 2011
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Multicenter Study on Pancreatic Duct Stenting in Disrupted or Obstructed Ducts in Context With Endoscopic Treatment of Pancreatic Pseudocysts.
- ClinicalTrials.gov ID
- NCT01276002
- Acronym / sponsor ID
- Disduct / UKSH-122010
- Conditions
- Chronic Acute Pancreatitis
- Keywords
- disrupted duct, pancreatic pseudocysts
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No appropriate participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 13 Jan 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.
The disruption of the pancreatic duct seems to be a major cause pseudocyst formation and persistence in patients suffering from acute/chronic pancreatitis. No prospective randomized studies have been conducted on the influence of pancreatic duct stenting for the patients' benefits and recurrence rates. The aim fo this study is therefore to evaluate prospectively in a randomized, controlled fashion in patients wit pancreatic pseudocysts, wether pancreatic duct stenting of a disrupted pancreatic duct is beneficial in terms of quicker clinical recovery and avoidance of recurrence of pancreatic pseudocysts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No stenting | No intervention | –Control group, no stenting of the pancreatic duct in case of a disrupted duct |
| Pancreatic duct stenting | Active comparator | Procedure: pancreatic duct stentingin case of a disrupted pancreatic duct, patients will undergo pancreatic duct stenting in this arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- pancreatic pseudocyst, at least 6 cm in diameter
- symptomatic pancreatic pseudocyst
- increasing size of pancreatic pseudocyst within 6 weeks
Key exclusion criteria (10 listed)
- Pregnancy
- Age less than 18 years
- Postoperative status preventing access to papilla
- Allergy to contrast preventing from ERP
- Missing informed consent to study
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 |
|---|---|---|
| pancreatic duct stentingin case of a disrupted pancreatic duct, patients will undergo pancreatic duct stenting. | Procedure or surgery | Pancreatic duct stenting |
Primary outcome
Recurrence of pancreatic pseudocyst
Time frame: two years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
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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.
Mark Ellrichmann, MD principal investigator
Interdisciplinary Endoscopy, University hospital Schleswig-Holstein, Campus Kiel, Germany
Annette Fritscher-Ravens, MD, PhD study director
Interdisciplinary Endoscopy, University hospital Schleswig-Holstein, Campus Kiel, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pancreatic duct stenting in people with Chronic Acute Pancreatitis, run by University Hospital Schleswig-Holstein at 1 site 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 10 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: withdrawn, as of the sponsor's last update on 6 Jul 2022. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Recurrence of pancreatic pseudocyst (time frame: two 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 6 Jul 2022.