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WithdrawnNCT01276002DisductUpdated Jul 6, 2022

Evaluation of Pancreatic Duct Stenting in Patients With Pancreatic Pseudocysts.

An interventional study of pancreatic duct stenting in Chronic Acute Pancreatitis, sponsored by University Hospital Schleswig-Holstein. Withdrawn at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-06.

Sponsored by University Hospital Schleswig-Holstein · Not applicable, Interventional, and Treatment

Why this study was withdrawn
No appropriate participants
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Chronic Acute Pancreatitis

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Keywords

  • disrupted duct
  • pancreatic pseudocysts
03

In context

Pancreatic Pseudocyst

31 studies on the registry are indexed under Pancreatic Pseudocyst; 9 are open to participants now.

Browse Pancreatic Pseudocyst studies →

Lead sponsor

University Hospital Schleswig-Holstein is the lead sponsor of 163 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • pancreatic pseudocyst, at least 6 cm in diameter
  • symptomatic pancreatic pseudocyst
  • increasing size of pancreatic pseudocyst within 6 weeks

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • No intervention
    No stenting

    Control group, no stenting of the pancreatic duct in case of a disrupted duct

  • Active comparator
    Pancreatic duct stenting

    in case of a disrupted pancreatic duct, patients will undergo pancreatic duct stenting in this arm

    Procedure: pancreatic duct stenting

Interventions

  • Procedurepancreatic duct stenting

    in case of a disrupted pancreatic duct, patients will undergo pancreatic duct stenting.

06

What researchers measure

Primary outcomes

  1. Recurrence of pancreatic pseudocyst

    Time frame: two years

07

Study locations

1 site
  • Interdisciplinary Endoscopy, University hospital Schleswig-Holstein, Campus Kiel
    Kiel, 24105, Germany
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2011, a primary completion of Dec 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 12, 2011
First posted
Jan 13, 2011
Start
Jan 2011
Primary completionActual
Dec 2016
CompletionActual
Dec 2016
Last update
Jul 6, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01276002
Responsible party
Mark Ellrichmann (Head Interdisciplinary Endoscopy, University Hospital Schleswig-Holstein) — Principal investigator
First posted
Jan 13, 2011
Start date
Jan 2011
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Jul 6, 2022

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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