Evaluation of Pancreatic Duct Stenting in Patients With Pancreatic Pseudocysts. (Disduct)
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ClinicalTrials.gov Identifier: NCT01276002 |
Recruitment Status
: Unknown
Verified December 2015 by Mark Ellrichmann, University of Schleswig-Holstein.
Recruitment status was: Recruiting
First Posted
: January 13, 2011
Last Update Posted
: December 7, 2015
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Condition or disease | Intervention/treatment | Phase |
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Chronic Acute Pancreatitis | Procedure: pancreatic duct stenting | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Randomized Multicenter Study on Pancreatic Duct Stenting in Disrupted or Obstructed Ducts in Context With Endoscopic Treatment of Pancreatic Pseudocysts. |
Study Start Date : | January 2011 |
Estimated Primary Completion Date : | December 2016 |
Estimated Study Completion Date : | December 2016 |

Arm | Intervention/treatment |
---|---|
No Intervention: No stenting
Control group, no stenting of the pancreatic duct in case of a disrupted duct
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Active Comparator: Pancreatic duct stenting
in case of a disrupted pancreatic duct, patients will undergo pancreatic duct stenting in this arm
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Procedure: pancreatic duct stenting
in case of a disrupted pancreatic duct, patients will undergo pancreatic duct stenting.
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- Recurrence of pancreatic pseudocyst [ Time Frame: two years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- pancreatic pseudocyst, at least 6 cm in diameter
- symptomatic pancreatic pseudocyst
- increasing size of pancreatic pseudocyst within 6 weeks
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01276002
Contact: Mark Ellrichmann, MD | +494315972075 | mark.ellrichmann@uk-sh.de | |
Contact: Annette Fritscher-Ravens, MD, PhD | +494315972075 | fri.rav@btopenworld.com |
Germany | |
Interdisciplinary Endoscopy, University hospital Schleswig-Holstein, Campus Kiel | Recruiting |
Kiel, Germany, 24105 | |
Contact: Mark Ellrichmann, MD +494315972075 mark.ellrichmann@uk-sh.de | |
Contact: Annette Fritscher-Ravens, MD, PhD +494315972075 fri.rav@btopenworld.com | |
Principal Investigator: Mark Ellrichmann, MD |
Principal Investigator: | Mark Ellrichmann, MD | Interdisciplinary Endoscopy, University hospital Schleswig-Holstein, Campus Kiel, Germany | |
Study Director: | Annette Fritscher-Ravens, MD, PhD | Interdisciplinary Endoscopy, University hospital Schleswig-Holstein, Campus Kiel, Germany |
Responsible Party: | Mark Ellrichmann, Head Interdisciplinary Endoscopy, University of Schleswig-Holstein |
ClinicalTrials.gov Identifier: | NCT01276002 History of Changes |
Other Study ID Numbers: |
UKSH-122010 |
First Posted: | January 13, 2011 Key Record Dates |
Last Update Posted: | December 7, 2015 |
Last Verified: | December 2015 |
Keywords provided by Mark Ellrichmann, University of Schleswig-Holstein:
disrupted duct pancreatic pseudocysts |
Additional relevant MeSH terms:
Pancreatitis Pancreatic Pseudocyst Pancreatic Diseases Digestive System Diseases |
Pancreatic Cyst Cysts Neoplasms |